16 APS exercise research highlights, from reduced flu mortality to proteomics & obesity

Keynote speaker Bengt Saltin bridges latest research, historic U.S.-European physiology, mentoring at APS exercise meeting, Oct. 6-9


BETHESDA, Md. (Sept. 28, 2004) - Bengt Saltin, keynote speaker at the 2004 APS Intersociety exercise meeting in Austin, Texas Oct. 6-9, weaves together a lifetime of learning and research experience that bridges the 1920 Nobel Prize for Physiology, the 1935 High Altitude Expedition to Chile, and the latest in international exercise physiology.


Dr. Saltin, director of the Copenhagen Muscle Research Centre, will draw on his early medical training with Erik Hohwu Christensen, a pupil of 1920 Nobel Prize in Physiology August Krogh who won for his work on increased muscle activity and oxygen diffusion. Christensen would later become famous for his work on the International High Altitude Expedition to Chile where he and his coauthors "fully confirmed...the opinion of Krogh, Barcroft and others that diffusion can account for the transfer of oxygen in the lung…."


Completing the circle, Saltin and several collaborators published an article on altitude effects on oxygen consumption in the September 2004 issue of the American Journal of Physiology-Heart and Circulatory Physiology. (See below for references.) Saltin will discuss how Krogh and Christensen "conceived and formed the field of human integrative physiology using exercise as a key intervention," how American and European approaches to exercise physiology bifurcated, and where this type of physiology might be leading.


Among his many honors, Bengt Saltin received the International Organizing Committee 2002 Olympic Prize, which is underwritten by Pfizer Inc. In 1990 Saltin received the Honor Award from the American College of Sports Medicine, which honored Erik Hohwu-Christensen with the same award in 1981.



Editors note: Saltin is speaking at the American Physiological Society's 2004 Intersociety Meeting, "The Integrative Biology of Exercise," Oct. 6-9 in Austin. Information about the meeting can be found at (the-aps/meetings/aps/austin).


A detailed program, including abstracts, for the entire meeting is available upon request to members of the media.


Arrangements for on-site interviews, or telephone interviews during the meeting can be arranged through APS from Mayer Resnick (cell: 301-332-4402, mresnickthe-aps) or Stacy Brooks 301-634-7253 (sbrooksthe-aps). From Oct. 5-9, the onsite phone number in Austin is 512-482-8000, room 602.



The meeting is cosponsored by APS, the American College of Sports Medicine and the Canadian Society for Exercise Physiology. Additional support through unrestricted educational grants came from: the National Aeronautics and Space Administration (NASA), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMSD), Gatorade Sports Sciences Institute, Pfizer Inc. and the U.S. Army Research Institute of Environmental Medicine (USARIEM).















* * *


Summaries of 16 selected presentations at the Austin exercise meeting Oct. 6-9, 2004.


Ronald L. Terjung, chair of the meeting organizing committee and professor in the Department of Biomedical Science at the University of Missouri-Columbia, College of Veterinary Medicine, noted that in addition to the 12 symposia of invited speakers, ample time each day has been set aside for discussing the over 380 presentations with the authors.


Below are summaries of a few of the top presentations, with their program references.


1.5

Charles H. Turner (Indiana University, Indianapolis)

Mechanisms for increasing bone mass by exercise.

Mechanical loading through exercise builds bond mass, with the effects most pronounced during skeletal growth and development; rest periods reduce the effect of desensitization though it's unclear how this process is effected.


2.4.

David Proctor and Dennis Koch (Pennsylvania State University, University Park)

Influence of aging on skeletal muscle blood flow in healthy humans.

Active leg sympathetic vasoconstrictor responsiveness appears to be greater in older men during exercise.


4.17

Adrienne Visocchi, et al. (McMaster University, Hamilton, Canada)

The effect of isometric arm or leg exercise on resting blood pressure and arterial distensibility in persons medicated for hypertension.

Isometric handgrip (IHG) exercise seems to significantly reduce systolic blood pressure and carotid arterial distensibility.


6.3

Cheri L.M. McGowan, et al. (McMaster University, Hamilton, Canada)

IHG training improves blood pressure and endothelial function in persons medicated for hypertension.
Reduced reactive hyperemic flow, accompanied by improvements in normalized flow mediated dilation suggests a heightened vasoactive sensitivity to the reactive hyperemic stimulus, implicating it as a mechanism for improved cardiovascular function.


12.3

Thomas J. Hawke (York University, Toronto, Canada)

Molecular mechanisms of skeletal muscle regeneration.

Completion of the Human Genome Project and advent of microarray and proteomics technologies should facilitate an expanded analysis of the complex processes that regulate the myogenic progenitor cell and characterize the discrete stages of the muscle repair process.


12.4

Natasha Frank, et al. (Children's Hospital Boston, Mass.)

Expression of early developmental genes by human fetal skeletal muscle side population cells.
Early developmental mechanisms may be preserved in later stages of muscle cell commitment and differentiation and are likely to be involved in maintaining muscle side population cells in an undifferentiated state and available on demand for muscle regeneration.


13.4

Bente Klarlund Pedersen (University of Copenhagen, Denmark)

The biological role of the myokine IL-6. Muscle-derived IL-6 fulfils the criteria of an overriding exercise factor and such classes of cytokines should be renamed "myokines."


17.7

Steven E. Black, et al. (University of Massachusetts, Amherst)

Improved insulin action following short-term exercise training: effects of exercise or energy balance?
Study suggests that subtle changes in energy balance that precede measurable fat loss play a key role in mediating the beneficial effects of exercise on whole-body insulin action.


20.23

Elizabeth Mitchell, et al. (University of Massachusetts, Amherst)

Effects of short-term exercise in negative or zero energy balance on cardiovascular disease (CVD) risk factors. CVD risk factors trended down in overweight, sedentary people after exercise with negative energy controls.


22.1

Arnt Erik Tjonna, et al. (Norwegian Univ. of Science & Technology, Trondheim)

Maximal strength training improves work economy in patients with chronic obstructive pulmonary disease (COPD).

Substantial improved rate of force development indicates that strength training with emphasis on maximal mobilization in the concentric part of a leg press device improves work economy in COPD patients.


23.5

Stan L. Lindstedt, et al. (Northern Arizona University, Flagstaff)

Design of muscle for function as a spring.

Titin may function as a major component in the vertebrate muscle spring and the "spring properties" of muscle can be exploited clinically.


24.4

Rainer P. Hambrecht (Heart Center, Leipzig, Germany) Effects of exercise training on vascular function and myocardial perfusion.

Since the degree of coronary endothelial dysfunction has been identified as a predictor of cardiac events, exercise may contribute to long-term reduction of cardiovascular morbidity and mortality.


24.5

Jeff Woods and Tom Lowder (University of Illinois, Urbana)

Protective effect of exercise on mortality due to influenza in mice.

Moderate exercise for four consecutive days post-infection significantly increased survivability to influenza infection.


28.1

Ronald N. Cortright, et al. (East Carolina University, Greenville, SC)

African-American women have increased rates of fat oxidation after 10 days of endurance exercise training (EET).

Since 10 days of EET increases skeletal muscle fatty acid oxidation similarly in African-American and Caucasian women, EET should work as a treatment against obesity and diabetes for both.


33.14

L. Lawrenson, et al. (University of California at San Diego)

COPD patients reveal attenuated muscle plasticity following isolated quadriceps training.
Findings support the restoration of skeletal muscle power and metabolic capacity in COPD patients towards sedentary control levels, yet even during isolated small muscle mass exercise, provide evidence of attenuated muscle plasticity associated with COPD.


36.6

Dustin Hittel, et al. (Children's National Medical Center, Washington, D.C.)

Using genomic and proteomic techniques to investigate exercise adaptation in untrained and overweight men and women.

Comparative mRNA and proteomic profiling provides unique insight into underlying metabolic crisis in chronically untrained muscle and clues as to how exercise reverses these effects.





References


Several of August Krogh's articles from the American Journal of Physiology are available in the American Physiological Society's recently completed Legacy Project, as is one by Christensen.


"Kinematographic methods in the study of capillary circulation," by August Krogh and P. Brandt Rehberg, from the Laboratory of Zoophysiology, University of Copenhagen, Denmark, AJP April 1924.



"The progress of physiology," by August Krogh, AJP October 1929.


"Gas equilibria in the lungs at high altitudes," by D.B. Dill, E.H. Christensen and H.T. Edwards (from the Fatigue Laboratory, Harvard University, Boston, and the Laboratory of Zoophysiology, Copenhagen University), AJP April 1936.


"Plasma volume expansion does not increase maximal cardiac output or maximal oxygen consumption in lowlanders acclimatized to altitude" by Jose A.L. Calbet, Goran Radegran, Robert Boushel, Hans Sondergaard, Bengt Saltin, and Peter D. Wagner appears in the September 2004 issue of AJP-Heart, which is published by the American Physiological Society. Calbet is at the Dept. of Physical Education, University of Las Palmas, Canary Islands, Spain; Calbet, Radegran, Boushel, Sondergaard and Saltin are at the Copenhagen Muscle Research Center, Rigshospitalet, Copenhagen; Boushel is also at Dept. of Exercise Science, Concordia University, Montreal, Canada; and Wagner is at the University of California at San Diego.


* * *


The American Physiological Society was founded in 1887 to foster basic and applied bioscience. The Bethesda, Maryland-based society has more than 10,000 members and publishes 14 peer-reviewed journals containing almost 4,000 articles annually.


APS provides a wide range of research, educational and career support and programming to further the contributions of physiology to understanding the mechanisms of diseased and healthy states. In May, APS received the Presidential Award for Excellence in Science, Mathematics and Engineering Mentoring (PAESMEM).


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High-fat Low-carb Diets Could Mean Significant Heart Risk

New scientific research has shown that low-carbohydrate high-fat diets, made popular by the likes of the Atkins diet, do not achieve more weight loss than low-fat high-carbohydrate diets. Worryingly, the research, lead by Dr Steven Hunter from the Royal Victoria Hospital, Belfast, also shows significantly increased risks of cardiovascular disease for people following low-carbohydrate high-fat diets.


The research shows that the risks of low-carbohydrate high-fat diets far outweigh the potential benefits gained by overweight and obese people through weight loss, including improvements in blood pressure and risk factors for coronary heart disease.


The research results, released hot on the heels of both National Obesity Week and World Diabetes Day, are particularly important for nearly a quarter (24%??) of the UK adult population, and 16% of the child population, now classified as obese and at risk of Type 2 Diabetes - 80%?? of all people diagnosed with Type 2 diabetes are overweight. Type 2 Diabetes is the result of inadequate insulin production and/or insulin resistance, which means that the right levels of glucose (our main source of energy from food) are not maintained naturally by the body. There are 180 million people in the world with diabetes and the World Health Organisation predicts this number will double in the next 20 years.


Dr Hunter, Royal Victoria Hospital, Belfast, said: "The worldwide obesity pandemic is a major public health concern and strongly linked to rises in diabetes and cardiovascular disease. By advocating low-carbohydrate high-fat diets as a weapon against obesity and diabetes, health professionals could be contributing to a dangerous rise in cardiovascular disease".


The research study, conducted among a group of obese pre-diabetic adults, compared the results of following a low-fat high-carbohydrate diet (20% fat, 60% carbohydrate) with a high-fat low-carbohydrate diet (60% fat, 20% carbohydrate). It showed that in all areas, other than the risk of cardiovascular disease, the diets have equal health benefits. The same amount of weight is lost; there is no significant difference in the body's glucose uptake or production; and meal tolerance-related insulin secretion is comparable. However, the study revealed a significant difference in overall systemic arterial stiffness and pointed to increased cardiovascular risk factors from high-fat low-carbohydrate diets.


Dr Hunter continued: "High-fat diets have become popular because they seemingly promote more rapid weight loss and because of their palatability. However, we now have proof that they do not help people lose weight any faster than more conventional diets, and the potential negatives of increased cardiovascular risks far outweigh the potential positives of more easily sustained dieting/weight loss, especially when there is a proven and safe alternative in low-fat high-carbohydrate weight loss diets."


According to Dr Hunter, the challenge now is to find ways to make low-fat high-carbohydrate diets more palatable and easier to maintain, so that a long-term positive outcome is achieved.


The Food Standards Agency says that saturated fat should account for less than 11% of the total diet for a normal person, and Dr Hunter concludes: "If your New Year's resolution is to lose weight, make sure you do it the right way and don't burden your body with additional unnecessary health risks by falling for the lure of the seemingly easy and fast weight loss offered by high-fat diets. The best approach for your overall health is a low-fat high-carbohydrate diet, coupled with exercise."


?? NHS Statistics on obesity, physical activity and diet: England, January 2008, published 31 January 2008


?? Diabetes UK


Reference


Bradley U et al.

"Low-fat versus low-carbohydrate weight reduction diets: effects on weight loss, insulin resistance and cardiovascular risk. A randomised trial."

Diabetes. December 2009, vol.58, no. 12, 2741-2748. doi: 10.2337/db09-0098

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Data Shows ENBREL Provides Sustained Clinical Improvements For People With Ankylosing Spondylitis For Up To Three Years

Amgen (NASDAQ:AMGN), today announced that data from an ongoing open-label, multinational, phase 4 extension study showed that patients with ankylosing spondylitis (AS) who received treatment with Enbrel(R) (etanercept) experienced sustained improvement in signs and symptoms, spinal mobility and physical function over 148 to 160 weeks of therapy. These results are consistent with an ENBREL phase 3 clinical trial at 24 weeks. The 160-week results will be presented at the American College of Rheumatology (ACR) Scientific Meeting in Washington, D.C.


"These data demonstrate that ENBREL can provide substantial long-term improvement in AS symptoms such as total back pain and spinal mobility," said Joachim Sieper, M.D., professor of rheumatology, Charite University in Berlin, Germany. "Because AS is a chronic inflammatory disease that requires ongoing management, it is important to offer patients a treatment option that is effective, has an established safety profile, and can be used over the long-term."


Data presented at ACR showed that 59 patients who received open-label ENBREL treatment for up to 160 weeks experienced sustained clinical improvements. Overall, 78 percent of patients (n=46) continuing treatment with ENBREL achieved a 20 percent improvement in the Assessment on Ankylosing Spondylitis Response Criteria (ASAS 20) after 160 weeks of treatment. ASAS is a composite measure of improvement in AS symptoms that include total back pain, patient assessment of disease activity, inflammation and physical function. Thirty-one percent of patients (n=18) achieved partial remission at week 160. Partial remission, as defined by ASAS, is a low disease activity level (score less than 20 units out of 100 in each of the four ASAS criteria).


Additional ENBREL data presented at ACR from this phase 4 extension study show that improvement in spinal mobility was also sustained through 148 to 160 weeks of treatment with ENBREL.


Patients with ankylosing spondylitis have reported that their condition has negatively impacted their ability to perform daily activities including exercising, rising from a seated position and climbing stairs without aid. Overall, patients treated with ENBREL achieved a 46 percent improvement in physical function, as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI), and these results were sustained through 160 weeks. The BASFI is a 10-question, patient self-assessment instrument consisting of 8 specific questions regarding physical function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10).


ENBREL was generally well tolerated over 148 to 160 weeks of therapy.















This study was designed to assess the safety and long-term efficacy of ENBREL in patients with AS, using clinical measures to assess disease activity, physical function, improvement in AS symptoms, and ongoing surveillance to assess the incidence of adverse events. The study is a 96-week open-label, multinational, phase 4 extension study in 59 patients with AS who completed each of two earlier trials, a 12-week randomized, double-blind, placebo-controlled study and a 96-week open-label study. The data presented at ACR is from the first 52-weeks of an ongoing 96-week extension study (total ENBREL treatment 148 - 160 weeks).


Enbrel received FDA approval to treat the signs and symptoms of active AS in 2003 following a randomized, double-blind, placebo-controlled phase 3 study in 277 patients with active ankylosing spondylitis. Treatment with ENBREL (n=138) resulted in significant clinical improvements through 24 weeks, compared to placebo (n=139). At 12 weeks, the ASAS 20 response was achieved by 60 percent of patients receiving ENBREL, compared to 27 percent of patients receiving placebo (p less than or equal to 0.0001, ENBREL vs. placebo). These results were maintained through 24 weeks. Patients in this study were between 18 and 70 years of age and had ankylosing spondylitis as defined by the modified New York Criteria for Ankylosing Spondylitis. Patients with complete ankylosis of the spine were excluded from study participation. Patients taking hydroxychloroquine, sulfasalazine, methotrexate, or prednisone (less than or equal to 10 mg/day) could continue these drugs at stable doses for the duration of the study. Doses of 25 mg ENBREL or placebo were administered subcutaneously twice a week for 6 months. The primary measure of efficacy was a 20 percent improvement in the Assessment in Ankylosing Spondylitis (ASAS) response criteria.


ABOUT AS


Ankylosing spondylitis, which affects up to half a million people in the United States, is a chronic, painful and progressive inflammatory disease affecting joints and ligaments that normally allow a person's back to move and flex. The disease most often occurs in the lower back but can affect the upper spine, chest and neck. In more advanced disease, the spine can fuse, causing loss of motion and a permanent stooped-over posture. AS may also involve other joints, such as the hips, shoulders, knees and ankles. Unlike other forms of arthritis, AS frequently affects individuals between the ages of 17 and 35. It tends to affect more men than women.


ABOUT ENBREL


ENBREL is a fully human soluble TNF receptor. ENBREL has more than 14 years of collective clinical experience.


ENBREL is indicated for:


-- reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.


-- reducing signs and symptoms of moderate to severe polyarticular-course juvenile rheumatoid arthritis in patients who have failed one or more disease modifying anti-rheumatic drugs (DMARDs).


-- reducing signs and symptoms, keeping joint damage of active arthritis from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used with methotrexate in patients who do not respond adequately to methotrexate alone.


-- reducing signs and symptoms in patients with active ankylosing spondylitis.


-- the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.


ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.


All medicines have side effects, including ENBREL. Possible side effects of ENBREL include:


-- Serious infections


-- Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes


-- Some serious infections have been fatal


-- Rare cases of tuberculosis have occurred


-- What not to do


-- Do not start ENBREL if you have an infection, such as an open sore or the flu, or are allergic to ENBREL or its components


-- What to do


-- Tell your doctor if you are prone to infection


-- Stop ENBREL if a serious infection occurs


-- Contact your doctor if you have questions about ENBREL or develop an infection

-- Tell your doctor if you have ever been treated for heart failure


-- Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes


-- Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL


-- Rare reports of serious blood disorders (some fatal)


-- Contact your doctor immediately if you develop symptoms, such as persistent fever, bruising, bleeding, or paleness


-- In medical studies of all TNF blockers, including ENBREL, a higher rate of lymphoma (a type of cancer) was seen compared to the general population. The risk of lymphoma may be up to several-fold higher in rheumatoid arthritis and psoriasis patients


-- The role of TNF blockers, including ENBREL, in the development of lymphoma is unknown
-- ENBREL can cause injection site reactions


-- In a medical study of patients with JRA, infections, headaches, abdominal pain, vomiting, and nausea occurred more frequently than in adults


-- The kinds of infections reported were generally mild and similar to those usually seen in children


-- Other serious adverse reactions were reported rarely, including serious infections (2%) and depression/personality disorder (1%)


About Amgen and Wyeth


Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL. Additional information about ENBREL, including full Prescribing Information, can be found on the Web site sponsored by the companies at enbrel or by calling toll free 888-4ENBREL (888-436-2735).


Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit amgen.


Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.


Forward-Looking Statement


This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2005, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.


No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. In addition, sales of Amgen's products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, Amgen competes with other companies with respect to some of Amgen's marketed products as well as for the discovery and development of new products. Amgen believes that some of the newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.


The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third-party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


An electronic version of this news release may be accessed via our Web site at amgen. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site.



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Herbal Medicines For Treatment Of Gastrointestinal Disease

Herbal medicines could benefit patients suffering from gastrointestinal (GI) motility disorders that cannot be treated using conventional drug therapy. In a study published in Neurogastroenterology and Motility, researchers reviewed data on Japanese herbal medicines and found them to be effective in reducing the symptoms of GI disorders such as functional dyspepsia, constipation, and postoperative ileus.


"Japanese herbal medicines have been used in East Asia for thousands of years," says lead researcher Hidekazu Suzuki, Associate Professor at the Keio University School of Medicine. "Our review of the world medical literature reveals that herbal medicines serve a valuable role in the management of patients with functional gastrointestinal disorders."


Many of the drugs used to treat GI motility disorders are ineffective or cause unwanted side effects and, in some cases, this has led to drugs being withdrawn from the market. Herbal medicine is an attractive alternative.



The researchers reviewed data from studies looking at the effect of several different Japanese herbal medicines including the use of Rikkunshi-to, Dai-Kenchu-to, and other herbal medicines. Rikkunshi-to, which is prepared from eight crude herbs, was effective in reducing discomfort caused by functional dyspepsia. Dai-Kenchu-to, a mixture of ginseng, ginger, and zanthoxylum fruit, was beneficial for constipation in children and patients suffering from post-operative ileus - disruption of normal bowel movements following an operation. Another herbal medicine, hangeshashin-to, reduced the severity and frequency of diarrhoea caused by anti-cancer drugs.


In Japan, herbal medicine is manufactured in standardised form with regards to quality and quantity of ingredients. The researchers say the health benefits of standardised formulations of herbal medicines require more rigorous examination, particularly in the Western world.
"There is a mandate to provide accurate data regarding the effectiveness of non-traditional therapy, not only to our patients but also to healthcare providers who face the dilemma of recommending or opposing management strategies that incorporate herbal medicine," says Suzuki.


Full citation: Suzuki, H., Inadomi, J.M. and Hibi, T.; Japanese Herbal Medicine in Functional Gastrointestinal Disorders; Neurogastroenterology and Motility (2009); DOI: 10.1111/j.1365-2982.2009.01290.x


Neurogastroenterology & Motility is the official Journal of the European Society of Neurogastroenterology and Motility, the American Neurogastroenterology & Motility Society and the Functional Brain-Gut Research Group. Edited by Jan Tack, Keith Sharkey and Joseph Szurszewski, it has an ISI Journal Citation Reports® Ranking: 2007 of 14/50 (Gastroenterology & Hepatology) and 68/211 (Neurosciences), and an Impact Factor of 3.364. The field of gastrointestinal motility has undergone phenomenal growth and change in the past three decades since it emerged as a distinct speciality. Neurogastroenterology & Motility provides a forum where current issues and advances relating to the motor function of the GI tract can be presented and discussed. It is of interest to both clinicians and researchers. For further information please visit www3.interscience.wiley/journal/118498177/home


Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley's Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal.

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Study Results Present Paradigm Shift; REDUCE Trial Shows New Hope For The Risk Reduction Of Prostate Cancer

The recent announcement of the REDUCE trial results at the American Urological Association annual meeting in Chicago brings optimism to the prostate cancer community as dutasteride (Avodart), a drug used to treat benign prostatic hyperplasia, has shown to lower by 23 percent the risk of prostate cancer in men with an increased risk of the disease.


Men's Health Network looks forward to this becoming an additional tool in the fight against prostate cancer.


The REDUCE trial is a placebo-controlled study that evaluates whether dutasteride decreases the risk of biopsy-detectable prostate cancer.


As this disease continues to strike one in six American men, with African American men having an incidence rate up to 60% higher than white men, it is important that patients and physicians engage in a meaningful conversation about prostate cancer, an individual's risk of getting the disease, and the value of early detection and prevention.


Scott Williams, Vice President, Men's Health Network commented, "We continually stress the importance for men to receive a baseline Prostate Specific Antigen or PSA and physical exam of the prostate at age 40 and to engage in a continual dialogue with their physician about their individual risk and need for annual prostate exams. It could mean the difference between living with the disease or dying from the disease."


PSA is currently the most effective tool physicians and patients have to detect a disease that kills an estimated 28,000 men a year in the US.


In addition to the approximately 200,000 men who are diagnosed with prostate cancer each year, we must remember that the disease can have a devastating effect on entire families and communities. Spouses, significant others, and children are often emotionally, financially, and physically strained and the diagnosis reaches beyond the family to impact friendships, employers, and churches.


"It is also important to note that families can impact the prevention and early detection of prostate cancer," said Theresa Morrow of Women Against Prostate Cancer. "Just a little encouragement from a spouse or family member can get a man to the doctor for prostate screening."


The REDUCE trial is the first step in a paradigm shift in the way prostate cancer is viewed, changing the conversation to focus on the value of prevention and early detection of this deadly disease.

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CINVENTION And Relisys Medical Devices Enroll First Patients In Clinical Trial Of The Corel + C Drug-Eluting Stent

COREL is a prospective,
open label randomized clinical trial that will enroll 150 patients in 10
centers in India. The primary endpoint is 9-month in-stent late loss within
the stented segment post-procedure and historical comparison with 6 to
9-month in-stent late loss with other drug-eluting stents. The secondary
endpoints include Angiographic Binary Restenosis, Target Lesion
Revascularization (TLR), Target Vessel Revascularization (TVR) and Target
Vessel Failure (TVF) rates at nine months, Major Adverse Cardiac Events
(MACE), acute, sub-acute and late Stent thrombosis at 30 days and 9 and 12
months, Lesion, Device as well as Procedure success. The Principal
Investigator of the study is Dr. Balram Barghava MD. of All India Institute
of Medical Sciences, New Delhi, India.


Relisys' new Corel + C drug-eluting stent comprises a Cobalt-Chromium
Stent that is coated with a macro-porous nano-structured carbon-composite
matrix containing the active drug paclitaxel. The coating has been
developed and provided by CINVENTION, the Germany based company specialized
in nano- composite materials and surface engineering. The coating
eliminates the use of polymers and provides a bioactive coating with less
thrombogeneity and pro- endothelialization surface design - thus,
completely reducing tissue inflammation and reaction, but additionally
enhancing engraftment and endothelialisation.


Dr. Balram Bhargava, the principal investigator, explained that he
expects significant improvements in the short, mid and long-term clinical
outcomes. "This is the first time that a nano-structured coating is used as
an elution platform. The coating itself is made out of non-thrombogenic
glassy carbon, the bio-availability of paclitaxel is nearly hundred percent
and, additionally, the surface structure of the coating promotes
endothelial cell attachment and proliferation. We are confident that this
trial will show excellent results and demonstrate that the non-polymeric
bioactive nano- composite coating will reduce the late thrombosis issue
significantly," said Dr. Balram Bhargava.



The enrolment of the study will be carried out throughout 10 clinical
trial centers in Bangalore, Ahmadabad, Vellore, Bangalore, Chandigarh,
Hyderabad, New Delhi and Mumbai. Dr. Soheil Asgari, Chief Executive Officer
and Chief Technology Officer of CINVENTION, pointed out, that the enrolment
will be finished within 4 weeks. "The investigators community has access to
a large collective of patients and we expect the stenting of the patients
within four to five weeks." He also referred to previous pre-clinical data
that showed excellent histomorphometric and histopathology data indicating
the non- inflammatory and pro-healing properties of the coating. "The
CINVENTION coating replaces inflammatory polymers - either durable or
absorbable - by the most inert material known, i.e. carbon. CINVENTION's
technology enables the embedding of drug control properties together with a
surface design that attracts endothelial cells and allows attachment and
proliferation on the nano-structured surface". Furthermore, he said that
CINVENTION has created significant knowledge in surface design for tissue
engineering and mammalian cell cultivation. This knowledge was transferred
to the nano-structured design of the carbon-coating material.
















Badari Narayan, Managing Director of Relisys Medical, stated that he
expects a clear result demonstrating the superior performance of the Corel
+ C stent. "The Corel+ C stent has unique advantages. While other companies
are still in the early development phase of non-polymeric stents, Relisys
has gained a head start over the community. We combine the advantages of a
Cobalt Chromium stent with an excellent profile and deliverability together
with the proven drug paclitaxel and the most advanced coating platform. The
Corel + C stent was specifically designed to eliminate the potential
complications of thrombosis that are now identified as the main issues of
Drug-Eluting Stents."


The animal trials for the advanced Corel + C drug-eluting stent were
completed at the Cardiovascular Research Institute, Washington D.C., and
published in April 2006. The animal data have shown the safety and efficacy
of the Corel + C drug-eluting stent, including its innovative porous
carbon/carbon composite coating technology.



CINVENTION AG


CINVENTION AG is a leading technology company focusing on
nano-composite materials in biomedical applications (learn more about
CINVENTION at cinvention/.


CINVENTION's unique portfolio of Nano-Composite Systems includes: Drug
Delivery Coatings, Multifunctional Device Coatings, Advanced Cultivation
Systems for Bio-Processing and Systems for Tissue Engineering.


CINVENTION's mission is to exploit its proprietary and highly
innovative technology platform for materials and surface engineering of
nano-structured composites. Providing a sustainable portfolio of
applications in medical device engineering, bio-processing and chemical
processing CINVENTION solutions enable its customers to acquire superior
technologies for next generation applications.


Relisys Medical Devices


Relisys Medical Devices Limited is a leading Indian medical device
manufacturer, which has taken a lead in the indigenous development of
medical devices like coronary stents, catheters and critical care products
in India.



Relisys focus products includes: Drug-eluting stents,
Angiographic/Angioplasty catheters, Occlusive devices, Cardiac surgery
disposables and Critical care products.



Relisys Medical Devices mission is to make quality medical care
affordable through development of cutting edge technology and competitive
pricing. Relisys Manufacturing facilities include a stent coating division
and an integrated catheter manufacturing facility with in-house
compounding, extrusion, injection molding, braiding, welding, tipping,
grinding, sterilization and others.


Cinvention AG

cinvention/

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'Counseling Suicidal Clients' By Andrew Reeves

Counselling Suicidal Clients by Andrew Reeves, from University of Liverpool Counselling Service, is a new title for counselling practitioners published today by SAGE. This title addresses the important professional considerations when working with clients who are suicidal. It covers work on the 'bigger picture', including legal and ethical considerations and organisational policy and procedures, including how practitioners can work with the dynamics of suicide potential in the therapeutic process.



The book is divided into six main parts:
The changing context of suicide


The prediction-prevention model, policy and ethics


The influence of the organisation


The client process


The practitioner process


The practice of counselling with suicidal clients.

The book also contains chapters on the discourse of suicide, suicide and self-injury, and self-care for the counsellor. It is written for counsellors and psychotherapists, and for any professional who uses counselling skills when supporting suicidal people.



About the author:



Andrew Reeves is a Senior BACP Accredited Counsellor at the University of Liverpool Counselling Service. He is also a Registered Social Worker, with a professional background in child protection and adult mental health services. His research interests focus on developing therapeutic approaches to assessing suicide risk, and he has written extensively on this subject. He is also Editor of Counselling and Psychotherapy Research journal, and a regular columnist in Therapy Today.



Praise for the title:



"A uniquely accessible, comprehensive and practical guide. Essential reading for counsellors and psychotherapists and all helping professionals who work with clients at risk of suicide." Mick Cooper, Professor of Counselling, University of Strathclyde



"A 'must read' for counsellors of all experience levels, offering sound practical strategies alongside thought-provoking case studies and discussion points. Reeves addresses this difficult topic with depth, breadth and integrity. Excellent." Denise Meyer, developer and lead author of studentdepression



"Andrew Reeves brings together his experience as a social worker, counsellor and academic to explore the essential elements in working with suicidal clients. His openness and integrity in writing about this complex topic creates a valuable resource for reflective practice." Barbara Mitchels, Solicitor and Director of Watershed Counselling Service, Devon.



Paperback ISBN: 9781412946360 ??22.99



Hardcover ISBN: 9781412946353 ??65.00


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Higher Cancer Risk For Those With Gum Disease

Whether
they are smokers or non-smokers, people with gum disease have a higher
overall risk of cancer, according to an Article published on May 27,
2008 in The Lancet Oncology.



Gum disease, such as
periodontis or gingivitis, is associated with increased concentrations
of inflammatory markers in the blood. There is some debate, however,
about whether this systemic inflammation, the pathogenic invasion into
the blood stream, or the immune response to gum infection could
possibly affect cancer risk, overall or at specific sites.



To
explore the potential association between gum disease and cancer, Dr.
Dominique Michaud, Imperial College London, UK, and colleagues began a
study of male health professionals aged 40-75 years in 1986.
Questionnaires were sent to the living participants every two years,
and dietary questionnaires were sent every four years. The data
collected through these surveys included: baseline gum disease, bone
loss, the number of natural teeth, tooth loss, smoking history, food
intake, and any cancer diagnoses. The data were examined for the
overall cancer risk and compared to individual cancers, and more than
100 cases were documented.



In total, 48,375 men were
considered eligible for the study and followed for a median follow-up
period of 17.7 years. In this group, there were 5,720 cases of incident
cancer, excluding non-melanoma skin cancer and non-aggressive prostate
cancer. Of these, the most common cancers were colorectal (18% or
1043), melanoma of the skin (12% or 698), lung (12% or 678), bladder
(9.5% or 543) and advanced prostate cancer (9.5% or 541). After
adjusting for many known risk factors, including accounting for smoking
and dietary histories, the subjects who had a history of gum disease
had a risk of cancer that was 14% higher than those with no history of
gum disease.



Patients with a history of gum disease, in
comparison with those without a history of gum disease, had an
increased risk of cancer in certain specific sites as well, including:
36% increased in the lung, 49% increased in the kidney, 54% increased
in the pancreas, and 30% increased in hematological cancers. Patients
with 0-16 natural teeth at the baseline were also 70% more likely to
have lunch cancer than those with 25-32 teeth. In subjects who did not
smoke, gum disease was associated with a 21% overall cancer risk above
those without gum disease. In contrast, nonsmoker subjects had no
difference in risk based on lung disease.



In conclusion, the authors summarize their results: "Gum
disease was associated with a small, but significant, increase in
overall cancer risk, which persisted in never-smokers. The associations
recorded for lung cancer are probably because of residual confounding
by smoking. The increased risks noted for haematological, kidney, and
pancreatic cancers need confirmation, but suggest that gum disease
might be a marker of a susceptible immune system or might directly
affect cancer risk."



Periodontal disease, tooth loss, and cancer risk in male
health professionals: a prospective cohort study

Dominique S Michaud, Yan Liu, Mara Meyer, Edward Giovannucci, Kaumudi
Joshipura

Lancet Oncol 2008; 9: 550-58

DOI:10.1016/S1470-2045(08)70106-2

Click Here For Journal



Written by Anna Sophia McKenney

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Response Of Hepatocellular Carcinoma To Chemoembolization May Be Predicted By Functional MRI

Early knowledge of hepatocellular carcinoma (HCC) response to transcatheter arterial chemoembolization (TACE) is crucial for determining treatment success, timing of repeat treatment, and patient prognosis. Currently, magnetic resonance imaging (MRI) is used 1-3 months after treatment to evaluate anatomical tumor response, based upon changes in tumor size and contrast-agent enhancement. Alternatively, diffusion-weighted imaging (DWI) can be used as a functional imaging technique to depict thermally induced motion of water molecules. The extent of water mobility within biological tissues can be quantified by a parameter called the apparent diffusion coefficient (ADC). Recently, ADC values have been shown to change within days to weeks after therapy, which is earlier than changes seen by conventional HCC anatomical size assessment. However, no studies to date have reported the intra-procedural characteristics of ADC and whether these values can predict future tumor response at the time of chemoembolization.



A research article was published on July 7, 2010 in the World Journal of Gastroenterology. The research team led by Professor Reed A Omary, from Department of Radiology, Northwestern University, Chicago, used functional magnetic resonance imaging (MRI) to measure changes in tumor activity at the time of treatment, and compared them to tumor structural changes on conventional MRI at standard 1- and 3-months follow-up periods.



Their results suggest that patients whose intra-procedural ADC values increase or decrease by > 15% are more likely to have a favorable anatomical tumor response 1 month later.



This result is encouraging because early knowledge of HCC response after initial therapy is essential to revise prognosis and guide future therapy. Use of DWI and ADC mapping in conjunction with traditional anatomical imaging evaluation could further improve tumor response interpretation and subsequent treatment planning. At present, MR/Interventional radiology suites permit the acquisition of immediate quantitative functional imaging changes, in both tumor perfusion and now diffusion. Which of these two functional parameters is more effective as an intra-procedural biomarker to tailor HCC therapy awaits verification by future studies.



Reference:
Chung JC, Naik NK, Lewandowski RJ, Deng J, Mulcahy MF, Kulik LM, Sato KT, Ryu RK, Salem R, Larson AC, Omary RA. Diffusion-weighted magnetic resonance imaging to predict response of hepatocellular carcinoma to chemoembolization. World J Gastroenterol 2010; 16(25): 3161-3167

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GSK Begins Distributing HPV Vaccine Cervarix In Philippines; Gardasil Approved In Spain

GlaxoSmithKline on Saturday began distributing its human papillomavirus vaccine Cervarix in Manila, Philippines, less than one month after the country's Bureau of Food and Drugs approved the vaccine, the AP/CNNMoney reports (AP/CNNMoney. 8/25). Cervarix has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. Researchers in a 2006 study published in the online edition of the Lancet also found that Cervarix prevented infection with HPV strains 31 and 45, which together with strains 16 and 18 cause more than 80% of cervical cancer cases (Kaiser Daily Women's Health Policy Report, 8/15).

The Philippines food and drugs bureau last year also approved Merck's HPV vaccine Gardasil (AP/CNNMoney, 8/25). Gardasil has shown to be 100% effective in preventing infection with HPV strains 16 and 18 and about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains (Kaiser Daily Women's Health Policy Report, 8/20).

In related news, Spain's government on Friday said it had approved Gardasil for use in the country, Reuters reports (Reuters, 8/24).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.



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Advanced Kidney Cancer - Median Progression-free Survival Doubled For Patients Treated With Nexavar (sorafenib), Phase III Data

Bayer HealthCare today announced the publication of encouraging Phase III data on sorafenib tablets - a treatment for patients with advanced renal cell carcinoma (RCC/kidney cancer), in the New England Journal of Medicine (NEJM).


Sorafenib is the first, multi-kinase inhibitor indicated for the treatment of patients with advanced RCC who have failed prior interferon-alpha or interleukin-2 based therapy and also 1st line when patients are considered unsuitable for such therapy.


Patients treated with sorafenib demonstrated a doubling of median progression-free survival (PFS) (5.5 months vs. 2.8 months) compared to patients receiving placebo (p-value< 0.001)1. The data, as assessed by independent radiologic review, are taken from the largest randomised controlled trial ever conducted in advanced RCC known as 'Treatment Approaches in Renal Cancer Global Evaluation Trial' TARGET - study.


"Sorafenib and agents like it are exciting new treatments for patients with advanced kidney cancer who have no good standard options in this country at present," said study investigator Tim Eisen, Professor of Medical Oncology, Cambridge. He added: "The vast majority of patients can tolerate treatment easily. The main job for us now is to secure these drugs for the NHS."


TARGET - a multi-national, randomised, placebo-controlled Phase III study of sorafenib administered as a single agent was initiated in 2003.?  More than 900 patients with advanced RCC, who had previously failed one prior systemic therapy, were enrolled in 117 sites worldwide and randomised into two treatment arms of equal numbers to receive either 400 mg sorafenib or placebo twice a day. 1


PFS measures the time that a patient lives without evident tumour growth. In a planned sub-group analysis the benefit in PFS was seen in all subgroups studied, including patients who had not received conventional treatment, such as interleukin-2 or interferon-alpha. After the PFS endpoint was met in April 2005, Bayer discussed the clinical and statistical significance of this analysis with the principal investigators, the independent data monitoring committee and with regulatory authorities and agreed that it would not be ethical to continue the study with a placebo-control arm. The study was subsequently modified and all patients in the trial were offered access to sorafenib.


A further interim analysis of overall survival (OS) ? based on 367 deaths and after 48% of the placebo patients (216 patients) had crossed over to sorafenib showed that median overall survival was 19.3 months for patients in the sorafenib group and 15.9 months for those in the placebo group (p=0.02). This analysis did not reach pre-specified O'Brien-Fleming boundaries for statistical significance.1


In the phase III study, sorafenib was generally well tolerated. The most common reported treatment-emergent adverse events of any severity were diarrhoea, rash, fatigue, hand-foot skin reaction, alopecia, nausea, pruritus, hypertension, vomiting, erythema and dry skin.2















About Sorafenib:


When launched in July 2006, sorafenib was the first new kidney cancer treatment in
Europe for over 10 years.


Mechanism of Action:


Sorafenib is an oral multi-kinase inhibitor that targets both the tumour cell and tumour vasculature. In preclinical models, sorafenib targeted members of two classes of kinases (tyrosine kinases and serine/threonine kinases) known to be involved in both tumour cell proliferation (tumour growth) and tumour angiogenesis (tumour blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-??, c-KIT and FLT-3.2


Indication:


Sorafenib, (200 mg film-coated tablets) is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy and also 1st line when patients are considered unsuitable for such therapy.2


Sorafenib is being evaluated as a single agent in a Phase III clinical trial for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, a study that has completed enrolment. A Phase III clinical trial of Nexavar combined with carboplatin and paclitaxel in non-small cell lung cancer (NSCLC) for treatment-naive patients was initiated in the first half of 2006. In addition to company-sponsored trials, there are a number of sorafenib studies being sponsored by government agencies, cooperative groups, and individual investigators.


About Kidney Cancer:


The Disease:


More than 6,600 people are diagnosed with kidney cancer each year in the UK. Kidney cancer causes around 3,600 deaths each year in the UK.3
In adults in England and Wales almost 90% of malignant kidney tumours arise in the renal parenchyma and the renal pelvis.3 Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, causing up to 85 percent of all kidney cancers.4


Key Statistics:


Kidney cancer affects both men and women with a ratio of 5 new diagnoses in men for every 3 in women3
Between 1975 and 2002, the incidence of kidney cancer in the UK has almost doubled for both men and women aged over 65 years.3


In men incidence rates increased by 79% between 1975 and 2002 (from 7.1 in 100,000 in 1975 to 12.7 per 100,000 in 2002), and by 90% in women (from 3.2 to 6.1 per 100, 000) over the same time period, mainly affecting men over 65 and women over 55 years.3


Risk Factors:


The major risk factors for kidney cancer include age and sex, obesity, smoking, and several genetic and medical conditions. Other factors such as phenacetin use and occupation also increase risk but these exposures are not widespread and most likely account for a small number of cases.5


Symptoms:


In the early stages kidney cancer does not generally cause any symptoms.3

Late symptoms include6: blood in the urine - haematuria; low back pain unrelated to injury; a lump in the abdomen in the region of the kidneys; fatigue; weight loss; recurrent fevers not associated with colds or flu; high blood pressure; swelling of the ankles and legs.


Treatment:


The treatment of kidney cancer depends on the severity of the cancer and the patient's overall health. The main treatment for kidney cancer is surgery4, which is effective when all of the cancer is removed.


For further information please visit: info.cancerresearchuk


Nexavar(R) is a registered trademark of Bayer Pharmaceuticals Corporation.


About Bayer HealthCare:


Bayer HealthCare AG, with sales of approximately 9.4 billion Euros in 2005, is one of the world's leading, innovative companies in the healthcare and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. Bayer Pharmaceuticals Corporation is part of the new Global Pharmaceutical Division, established January 1, 2006, which consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Haematology/Cardiology; Oncology and Primary Care.?  Bayer HealthCare AG employed 33,800 people worldwide in 2005.


Bayer HealthCare AG's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.


bayerhealthcare


References:


1. Escudier B et al, New Engl J Med 2007 356 (2): 11-20

2. ? Nexavar Summary of Product Characteristics

3. Cancer Research UK, Cancer Statistics by Type, kidney cancer

4. Cohen N. N Engl J Med, 2005; 353:?  2477-2490

5. Quin, M., et al. Cancer Trends in England and Wales 1950-1999. ed., Vol. SMPS No. 66. 2001: TSO

6. American Cancer Society, Detailed Guide: Kidney Cancer - Surgery


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Trying To Improve On Activity Of Interferon-Alpha In Metastatic Renal Cell Carcinoma: Interferon Plus Cimetidine In A Phase III Randomized Trial

UroToday - Interferon-alpha (IFN) has been a mainstay in the systemic treatment of metastatic renal cell carcinoma (RCC) for decades, with response rates ranging from 3-15%. Unlike interleukin 2, it has shown a survival benefit for patients in phase III randomized trials. Recent advances in the development of targeted therapy for metastatic RCC may sideline IFN as a first choice in therapy na?ve patients, but research continues with therapies in combination with IFN to improve on historical results. Here, Kinouchi and colleagues, out of Japan, report on a phase III randomized trial comparing IFN alone to IFN with the type 2 histamine receptor antagonist cimetidine, a combination that had previously proved beneficial for patients with metastatic RCC in phase II trials.


Over a 4 year period, 71 patients from 32 institutions were accrued to this phase III trial with endpoints of response and time to progression. In the IFN arm, there was 1 complete response (CR) and 4 partial responses (PR), with 16 patients demonstrating stable disease, for a response rate of 13.9%. In the IFN + cimetidine arm, there were 2 CR, 8 PR, and 13 patients with stable disease, for a response rate of 28.6%. These response rates were not statistically significantly different (p=0.13). In the IFN arm, the median time to progression was 112 days, which was not significantly different from the 125 days seen in the IFN + cimetidine arm (p=0.87).


The authors conclude that the addition of cimetidine does not improve the activity of IFN in metastatic RCC.


By Christopher G. Wood, M.D.


Kinouchi T, et al.

J Cancer Res Oncol, 2006 Aug;132(8):499-504. Epub 2006 Apr 4

Link Here.


UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.


To access the latest urology news releases from UroToday, go to:

urotoday


Copyright © 2006 - UroToday


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Medifacts International Drives Innovation In Telemedicine For Clinical Trials

Medifacts International, Inc., one of the largest global providers of noninvasive cardiovascular diagnostic services, announced that they are once again leading the Cardiovascular Safety Services marketplace in innovation, expertise, and execution - this time with new innovations in the use of telemedicine, T-SMBP (Telemonitoring Self Measured Blood Pressure), in clinical trials.


T-SMBP allows for remote collection of blood pressure (BP) data from a subject's home. Telemonitoring and telemedicine are actively being implemented through health care providers for general patient care, specifically in patients being treated for heart failure, diabetes, cancer and hypertension. The transition and implementation of telemedicine in clinical trials provides many benefits to the conduct of the study. The benefits of implementing T-SMBP include: (i) electronic capture of BP data, which removes transcription errors; (ii) reduction in the number of office visits required by the subject; and perhaps most importantly (iii) real-time access to the subjects' BP data via study web portal, which allows for alert criteria process and real-time view of data trends and treatment effect.


Over the past two years, Medifacts has worked with their partners and devoted key resources to advancing the design, implementation and execution of T-SMBP in clinical trials to enhance a solution that is both functional and cost-effective. As the global leader in ABPM (Ambulatory Blood Pressure Monitoring), Medifacts was able to access its vast reservoir of real-time clinical trial ABPM experience to enhance its T-SMBP solution.


Medifacts will present best practices and case studies of effective implementation of T-SMBP in clinical trials at The Med-e-Tel 2010 Conference in Luxembourg, April 14-16, 2010.


Michael Woehler, Medifacts International's President and Chief Executive Officer said: "We are seeing a very positive reaction to our proactive approach regarding technologies, study designs and timetables. It's important to our clients that we be innovative and driven toward more effective solutions. Our commitment to serve our clients' needs continues to pay dividends as we advance our position as one of the top global companies providing cardiovascular safety solutions."


Source
Medifacts International, Inc.

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Use Of Low Dose Aspirin To Protect Against Cardiovascular Disease Should Be Abandoned

The latest issue of the Drug and Therapeutics Bulletin (DTB) reports that the use of low-dose aspirin to protect against heart attacks and strokes in individuals yet to develop obvious cardiovascular disease, should be abandoned.


Low-dose aspirin is widely used to prevent further episodes of cardiovascular disease in people who have already had problems such as a heart attack or stroke. This approach is known as secondary prevention. It is well established and of confirmed benefit.


Following an analysis of the available evidence, it is the use of aspirin in primary prevention with which DTB takes issue. This is for individuals without symptoms, who have not yet had, for example, a heart attack or stroke, but who may be at risk.


Across the European Union alone, cardiovascular disease accounted for two million deaths in 2000. "Worldwide, many people take aspirin every day in the belief that doing so helps prevent [cardiovascular disease]," says DTB.


DTB points to various guidelines issued between 2005 and 2008 that recommend aspirin for the primary prevention of cardiovascular disease in various groups of patients. Examples include people aged 50 and older with type 2 diabetes and those with high blood pressure.


However DTB indicates that current evidence does not support the routine use of low-dose aspirin in such groups. This is because of the potential risk of serious gastrointestinal bleeds that accompany its use and the slight impact it has on curbing death rates.


DTB recommends that doctors review all patients currently taking low-dose aspirin for primary prevention, either as prescribed or over-the-counter treatment. It adds that the decision about whether to maintain or discontinue treatment should be made only after fully informing patients of the available evidence.


DTB adds: "Furthermore, in our view, current evidence makes it hard to recommend starting aspirin for primary prevention."


DTB concludes: "??¦ current evidence for primary prevention suggests the benefits and harms of aspirin in this setting may be more finely balanced than previously thought, even in individuals estimated to be at high risk of experiencing cardiovascular events, including those with diabetes or elevated blood pressure."


"We believe, therefore, that low dose aspirin prophylaxis should not be routinely used for primary prevention."


"Aspirin for primary prevention of cardiovascular disease? "

DTB vol 47; No 11, November 2009.

doi:10.1136/dtb.2009.10.0045

dtb.bmj


Written by Stephanie Brunner (B.A.)

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Watercress: Anti-Cancer Superfood

Eating watercress daily can significantly reduce DNA damage to blood cells, which is considered to be an important trigger in the development of cancer, University of Ulster scientists revealed today (15 February).


The research, published in this month's American Journal of Clinical Nutrition, found that in addition to reducing DNA damage, a daily portion of watercress also increased the ability of those cells to resist further DNA damage caused by free radicals**.


The dietary trial involved 30 healthy men and 30 healthy women (including 30 smokers) eating an 85g bag (a cereal bowl full) of fresh watercress every day for eight weeks. The beneficial changes were greatest among the smokers. This may reflect the greater toxic burden or oxidative stress amongst the smokers, as smokers were also found to have significantly lower antioxidant levels at the start of the study compared to the non-smokers.


Professor Ian Rowland, who led the research project, said: "Our findings are highly significant. Population studies have shown links between higher intakes of cruciferous vegetables like watercress, and a reduced risk of a number of cancers. However, such studies don't give direct information about causal effects. What makes this study unique is it involves people eating watercress in easily achievable amounts, to see what impact that might have on known bio-markers of cancer risk, such as DNA damage. Most studies to date have relied on tests conducted in test tubes or in animals, with chemicals derived from cruciferous vegetables."


Prof. Rowland added: "Blood cell DNA damage is an indicator of whole body cancer risk, and, the results support the theory that consumption of watercress is linked to an overall reduced risk of cancer at various sites in the body. The nature of the study group also means that the results are applicable to the general population eating a normal diet."


The single blind, randomised, crossover study was carried out with volunteers aged between 19 and 55. The volunteers ate one daily portion of watercress in addition to their normal diet.


The key findings of the watercress diet are as follows:


-- significant reduction in DNA damage to lymphocytes (white blood cells), by 22.9 per cent.


-- reduction in DNA damage to lymphocytes (white blood cells) when a sample was challenged with the free radical generating chemical hydrogen peroxide, by 9.4%


-- reduction in blood triglyceride levels, by an average of 10%


-- significant increase in blood levels of lutein and beta-carotene, which have antioxidant activity, by 100% and 33% respectively(higher intakes of lutein have also been associated with a lower incidence of eye diseases such as cataract and age-related macular degeneration).















Average intakes of dietary fibre, vitamin C, vitamin E, folate and beta- carotene, were significantly higher during the watercress phase of the study.


The two year research project was funded by The Watercress Alliance, made up of British watercress producers, Vitacress Salads, Alresford Salads and The Watercress Company.


Member Steve Rothwell commented: "We have known for years that the special mustard oil in watercress, PEITC, has significant anticancer properties. But research on PEITC has been confined mainly to laboratory cultures or animal studies.


"This is groundbreaking research on two fronts: it suggests the anticancer properties of watercress go beyond those attributable to PEITC and, more importantly, the study is the first to demonstrate a direct correlation between eating watercress and reducing one's susceptibility to cancer"


The confidence to run this study came from a large body of existing evidence which has demonstrated the anti-cancer potential of watercress, including a laboratory study with human colon cancer cells, run by the same research group. Published in May 2006, the study showed for the first time that a watercress extract had beneficial effects on 'initiation', the DNA damage that triggers cancer cell development, 'proliferation' or uncontrolled growth of cancer cells, and 'metastasis', the spread of cancer cells. These are the three key stages of carcinogenesis, the process that results in cancer. Watercress extract was also shown to trigger cell death of cancerous calls a process known as apoptosis.


UK TV presenter and survivor of bowel cancer Lynn Faulds Wood commented: "The research from the University of Ulster is very interesting - it's great to know there are simple things that people can do - like eating watercress - which could help them avoid getting cancers like bowel cancer in the future. It's great that the watercress farmers want to raise awareness of bowel cancer, the commonest cancer in Europe. Thousands of people die unnecessarily of bowel cancer every year - with exercise and a good diet, many of them could live."


Cultivated in pure spring water, watercress has been revered as a superfood down the centuries. Hippocrates, the father of medicine, is said to have located his first hospital close to a stream to ensure fresh watercress to help treat his patients. Greek soldiers were given it as a tonic before going into battle and the 16th Century herbalist Culpepper claimed it could cleanse the blood. It is brimming with more than 15 essential vitamins and minerals. Gram for gram, it contains more iron than spinach, more vitamin C than oranges and more calcium than milk.


Watercress is the UK's most historic salad leaf and in the 19th Century was a staple part of the working class diet, most often eaten for breakfast in a sandwich. If people were too poor to buy bread, then they ate it on its own, which is why it was sometimes known as "poor man's bread." Bunches were handheld and eaten ice-cream cone style the first "on the go food."


After decades of being pushed to the side of the plate as nothing more than a decorative garnish, watercress is currently enjoying a renaissance, with sales increasing by ??18 million a year to ??55 million. Consumers and celebrities alike are re-discovering its distinctive peppery taste and its amazing nutritional benefits. Liz Hurley has been known to drink seven cups of watercress soup a day!


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Superiority Of Spiriva&reg; (Tiotropium) Over Long-Acting Beta Agonist Salmeterol In Reducing The Risk For COPD Exacerbations Demonstrated By Study

Results of the one-year Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD®) study, published today by the New England Journal of Medicine (NEJM), demonstrate that Spiriva® (tiotropium),*is superior to salmeterol,**in reducing the risk of exacerbations in Chronic Obstructive Pulmonary Disease (COPD).1 The POET-COPD® study is a large, one year head-to-head study designed to compare the effects of the long-acting anticholinergic Spiriva® with the long-acting beta agonist salmeterol on moderate to severe exacerbations in COPD.1 Exacerbations (sometimes referred to as COPD lung attacks due to the severe impact on patients' health), are a key indicator for disease progression and decline in lung function and their prevention is a major treatment goal.2,3,4


Results of the POET-COPD® Study


The results of the POET-COPD®study, which involved 7376 patients with moderate to severe COPD and a history of exacerbations, show that Spiriva® significantly delayed the occurrence of the first COPD exacerbation. A 17 percent overall risk reduction (p






COPD Exacerbations


COPD exacerbations (sometimes referred to as COPD lung attacks) are an acute worsening of COPD symptoms and have a severe impact on patients' health. Frequent exacerbations indicate a deterioration and progression of the disease.2,3,4 They are associated with a more rapid decline in lung function over time and, in severe cases, an increased risk of mortality, and they can severely compromise patients' health-related quality of life.2,3,4 Economic analyses suggest that hospitalisation due to COPD exacerbations accounts for 40-70 percent of all medical expenses for patients with COPD.9,10,11,12The cost of hospitalisation for COPD patients is estimated at $6.1 billion in the U.S.A. alone.12As hospitalisation accounts for the largest component of cost in the management of COPD, interventions reducing hospitalisation will have the greatest impact on the cost of treating COPD for all severities of the disease.9


The POET-COPD® study was a one-year, randomised, double-blind, double-dummy, parallel-group trial involving 7376 patients with moderate to severe COPD from 25 countries in 725 centres.1 The study was specifically designed to compare the effects on exacerbations of two long-acting bronchodilators; both are recommended as maintenance therapy of COPD by international guidelines and are widely used.13,14


"COPD exacerbations can occur even in the early stages of COPD (e.g. GOLD Stage II) and may recur throughout the course of the disease. They are associated with substantial personal, medical, societal and economic burden. Prevention of exacerbations constitutes a major treatment goal and is a key concern for COPD patients," said Professor Dr. Klaus Rabe, Department of Medicine, University of Kiel and Grosshansdorf Hospital, Germany. "The results of the POET-COPD® study, comparing two long-acting bronchodilators, should help to guide clinical practice in the management of COPD and the prevention of exacerbations."


* Via HandiHaler®

** Via HFA (metered-dose inhaler)

*** Global Initiative for Chronic Obstructive Lung Disease


Notes
About COPD


Chronic Obstructive Pulmonary Disease (COPD) is a progressive yet treatable disease that restricts patients' lives over time and is a major cause of death and disability throughout the world. Symptoms include cough, sputum (mucus or phlegm) production, and breathlessness on exertion. Acute worsening of these symptoms, i.e. exacerbations (sometimes referred to as COPD lung attacks due to their severe impact on patients' health) often occur and can restrict a patient's ability to perform normal daily activities.13 The latest World Health Organization (WHO) figures estimate that 210 million people are currently living with COPD and more than 3 million people died from the disease in 200515- more than breast cancer and diabetes combined.16Dyspnoea (breathlessness), the main symptom of COPD, is characteristically persistent and progressive and has a serious impact on patients' quality of life.13 At its most severe, it even limits a patient from performing simple tasks such as washing and dressing.


About the POET-COPD®Study


The Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD®) study was a one-year, multicentre (725 sites), multinational (25 countries), randomised, double-blind, double-dummy, parallel-group trial which included 7376 male and female COPD patients. The primary objective of this study was to compare the effect of Spiriva® (18 ?µg) inhalation capsule via HandiHaler® and salmeterol (50 ?µg) via HFA metered dose inhaler (MDI) on COPD exacerbations.1


Patients included in the trial had to be ?‰?40 years of age, have a smoking history of ?‰?10 pack-years and a diagnosis of moderate to very severe COPD with a history of at least one exacerbation within the previous year requiring treatment with either systemic steroids and/or antibiotics or hospitalisation.1


About Spiriva® (tiotropium)


Spiriva®, a long-acting inhaled anticholinergic medication, is the first inhaled treatment to provide significant and sustained improvements in lung function with once-daily dosing. Spiriva® positively impacts the clinical course of COPD, helping to change the way patients live with their disease.17,18It is the most prescribed maintenance therapy for COPD worldwide. Spiriva® helps COPD patients breathe easier by opening narrowed airways and helping to keep them open for 24 hours. Spiriva® works through targeting of a dominant reversible mechanism of COPD - cholinergic bronchoconstriction.


Spiriva® has demonstrated significant and sustained bronchodilation (opening of the airways)19and reduction in hyperinflation (air trapping).20,21 In placebo-controlled studies, patients treated with Spiriva® had less activity-induced breathlessness and improved exercise endurance.17In the UPLIFT® trial, Spiriva® demonstrated proven benefits for up to four years including improved lung function and quality of life as well as reduced exacerbations and COPD-related hospitalisations.22****These benefits were shown in a broad range of COPD severities, including patients with early-stage COPD (GOLD Stage II),23*patients new to maintenance therapy,24 * and younger patients (

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PEAK Surgical Receives 510(k) Clearance To Market PEAK(R) Surgery System For Use In General Surgery

PEAK Surgical, Inc., a
medical device company that has developed a new tissue dissection system
based on a proprietary technology, announced that the U.S. Food and
Drug Administration has granted the company 510(k) clearance to market its
PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System
combines the PULSAR(TM) Generator, which supplies pulsed plasma
radiofrequency energy, with the PEAK PlasmaBlade(TM) 4.0, a low-temperature
surgical cutting and coagulation tool. This tissue dissection system will
be commercially available next month.



"With the introduction of the PlasmaBlade, general surgeons now have
access to a single surgical tool that cuts tissue as precisely as a scalpel
and controls bleeding as effectively as traditional electrosurgery without
causing extensive collateral thermal damage to tissues," said John Tighe,
chief executive officer of PEAK Surgical.



In preparation for the commercialization of the PEAK Surgery System,
the company launched a redesigned corporate Web site, which can be accessed
at peaksurgical. The Web site provides detailed information
about all of the components of the PEAK Surgery System, including a cart
and wireless foot switch, as well as video, a brochure, fact sheets,
product images, scientific literature and surgeon testimonials, among other
information.



Benefits of the PlasmaBlade and PULSAR Generator



For decades, surgeons have relied on scalpels to cut skin and delicate
tissues and used electrosurgical devices to cut and coagulate fat and other
thicker, tougher tissues. Although scalpels precisely cut tissue, they do
not control bleeding. Electrosurgical devices, on the other hand, cut
efficiently and control bleeding but can cause extensive thermal damage to
surrounding tissue. In cases where the risk of collateral damage or
scarring from electrosurgery is considered to be unacceptable, surgeons
must use both a traditional scalpel for cutting and an electrosurgery
device for coagulation. The PlasmaBlade combines into a single surgical
tool the precision of a scalpel and the bleeding control of a traditional
electrosurgery device.



Unlike most radiofrequency-based surgical products that use continuous
voltage waveforms to cut tissue, the PULSAR Generator supplies pulsed
plasma-mediated electrical discharges through the PlasmaBlade. Because the
radiofrequency is provided in short on-and-off pulses and the blade
contains highly insulated electrodes, the PlasmaBlade cuts tissue at an
average temperature that is half that of a conventional electrosurgery
device and can be as low as 50 degrees Centigrade. This temperature
reduction results in reduced heat transfer and half the damage to
surrounding tissues compared with traditional electrosurgical devices. The
PlasmaBlade also can dissect tissue in a wet or dry surgical field.



The pulsed plasma-mediated discharges and electrode insulation
techniques were originally developed at the Hansen Experimental Physics
Laboratory and Department of Ophthalmology at Stanford University.
















"Surgeons typically must switch between a scalpel and a traditional
electrosurgery device depending on the surgical field and type of tissue
they are cutting," said Dr. Thomas M. Krummel, professor and chair of
surgery at Stanford University School of Medicine. "I believe the
PlasmaBlade has the potential to revolutionize the way surgery is performed
because it eliminates the need to change from one surgical tool to another
as a surgeon cuts through all types of soft tissue, including skin, fat and
muscle. It also has the ability to cut in a wet or dry surgical field, an
advancement over most electrosurgical tools in use today."



PlasmaBlade Study Results



Results of a preclinical surgical incision healing study of the
PlasmaBlade presented in an oral presentation at the American College of
Surgeons' Annual Clinical Congress in October 2007 demonstrated that it
efficiently cut tissue with effective bleeding control and minimal thermal
damage compared with standard surgical techniques. The PlasmaBlade reduced
bleeding by 60 percent compared with a scalpel, while providing the same
positive wound healing profile of minimal scarring and inflammation. In
addition, surgical incision healing and strength were significantly
improved with the PlasmaBlade compared with traditional electrosurgical
devices.



Additional preclinical studies of the PEAK Surgery System are underway.
PEAK Surgical is exploring the applicability of its technology across
numerous surgical fields beyond general surgery, including cardiothoracic,
gynecologic, plastic and reconstructive and neurosurgery. The company
believes the technology may have applications in more than 2 million
surgical procedures each year.



About PEAK Surgical, Inc.



PEAK Surgical, Inc. is a medical device company that has developed the
PEAK(R) Surgery System, a new tissue dissection system based on a
proprietary technology that represents an evolutionary leap in the
advancement of radiofrequency surgical technologies. The PEAK Surgery
System consists of the PEAK PlasmaBlade(TM) 4.0, a disposable cutting tool
that offers the exacting control of a scalpel and the bleeding control of
traditional electrosurgery without the extensive collateral damage, and the
PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy to
the PlasmaBlade. The PEAK Surgery System is cleared for use in general
surgery in the United States. The company is exploring the applicability of
this technology across additional surgical fields, including
cardiothoracic, gynecologic, plastic and reconstructive, and neurosurgery.
For more information, please visit peaksurgical.


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Forcing Evolution: Boosting Its Infectivity Turns Benign Virus Into Good Gene Therapy Carrier For Cystic Fibrosis

Researchers from the University of California, Berkeley, and the University of Iowa have turned a relatively benign virus into a highly infectious form that is ideal as a carrier for gene therapy.



In its first gene therapy test, it completely cured human cystic fibrosis lung tissue in culture.



This success with the benign adeno-associated virus (AAV), published this week in the online early edition of the journal Proceedings of the National Academy of Sciences, overcomes a major problem of earlier virus-based gene therapy for cystic fibrosis, and sets the stage for tests in advanced animal models of the disease.



"I think it is worthwhile thinking about clinical therapy at the levels of infection we are achieving," said coauthor David Schaffer, professor of chemical engineering at UC Berkeley.



A new pig model of cystic fibrosis developed last year by Schaffer's colleague, pulmonologist Joseph Zabner of the University of Iowa Hospitals and Clinics in Iowa City, will provide a key test of the virus as a carrier of a gene to replace the mutated gene responsible for the disease.



"If we are able to show that efficient gene transfer can result in gene therapy, if we can cure the lung disease of pigs that have been genetically engineered to have cystic fibrosis lung disease, we should have a real chance of curing cystic fibrosis in humans," Zabner said in an e-mail.



Schaffer's lab is collaborating with groups elsewhere to adapt the virus to gene therapy for other diseases, including Alzheimer's disease and amyotrophic lateral sclerosis (Lou Gehrig's disease).



"Both of those are situations where improvements in the properties of the vehicle can have a significant impact on the success of the therapy," Schaffer said.



Cystic fibrosis (CF) is a common hereditary disease that affects the body's mucus membranes, in particular the lungs, resulting in difficulty breathing and typically in death before the age of 40 from lung or organ failure. One in 4,000 children in the United States is born with CF.



Schaffer and his UC Berkeley colleagues collaborated with Zabner's laboratory to test a technique developed by Schaffer to force the evolution of a virus in ways that make it more effective in gene therapy.



Two years ago, Schaffer and colleagues used the technique to create a variant of AAV that more easily avoids the immune system, allowing the virus to remain in the body long enough to deliver a gene to its intended target.



Using the same technique, the team produced a variant of AAV that is several hundred times more effective at entering lung cells than the natural virus.
















Schaffer's technique involves making many mutations in AAV, culturing these variants with cells, and then taking those with specific improved properties - in this case, the ability to infect lung cells - and repeating the process.



"We probably conducted about six rounds of evolution in which we infected the lung epithelial cultures in Iowa, they sent it back to us, we recovered the viral sequences, made new viruses and sent them back again," Schaffer said. "It was iterative rounds of infection and selection for improved infection that finally led to this enhancement of function."



The main problem in CF is a mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene that results in a defective chloride ion channel in the body's cells. This, in turn, creates a chloride ion imbalance in the cell, which interferes with water transport in and out of the cell. In the lungs, this causes the mucus that lines the lung surface to become thick and sticky. Breathing becomes difficult if the mucus is not loosened, often by vigorous pounding on the chest, and coughed out. Respiratory infections are common, and lung failure often results. The ion channel defect also affects digestion, leading to nutritional deficiency.



According to Schaffer, previous attempts to deliver a normal CFTR gene to lung cells by means of a virus failed either because the immune system mopped up the virus before it had a chance to deliver its cargo, as was the case with adenovirus; or because the virus was inefficient at delivering the gene to cells, the case with adeno-associated virus. Most respiratory viruses tend to have low infection rates, apparently because they would otherwise quickly wipe out their host, Schaffer said.



Schaffer's technique forced the normally benign AAV, which has already infected over 90 percent of people without any harmful side effects, through rounds of directed evolution to increase its infectivity several hundred-fold.



"We devised a way to evolve viruses that are released from the natural constraints of evolution and have the freedom or ability to evolve toward properties that are more useful for medical application," he said. "In human lung tissue, it completely rescued the chloride ion transport properties of the cells after delivering the correct copy of the CFTR gene to replace the mutated copy of the gene that is present in cystic fibrosis patients."



In this case, the infectious AAV strain developed two major changes: Thanks to a mutation on the viral surface, it was able to bind to different receptors or bind to a more plentiful receptor on the cell surface; and it also acquired a mutation that gave the virus an enhanced ability to make it past the cell surface membrane, slip past the lipid bilayer and reach the inside the cell.



"Neither change alone was enough; it had to be the combination of the two that resulted in the improved properties," said Schaffer. "If we decided to use rational design, we wouldn't have known this. So, we left it up to evolution to discover the answer."







Coauthors with Schaffer and Zabner were James T. Koerber, a graduate student with UC Berkeley's chemical engineering and bioengineering departments and with the Helen Wills Neuroscience Institute; research scientist Katherine J. D. A. Excoffon and David D. Dickey of the University of Iowa; Matthew Murtha and Brian K. Kaspar of The Research Institute at Nationwide Children's Hospital in Columbus, Ohio; and Saf Keshavjee of Toronto General Hospital and the University of Toronto.



The research was funded by the National Institutes of Health and the Cystic Fibrosis Foundation.

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