Protalix Biotherapeutics, Inc. (NYSEAmex PLX), reported preclinical data on prantiTNF, a biosimilar version of etanercept (Enbrel™). Produced using the Companys proprietary ProCellEx™ technology, prantiTNF is a plant cell expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. PrantiTNF has an identical amino acid sequence to Enbrel™.

In vitro and preclinical animal studies have demonstrated that prantiTNF exhibits similar activity to Enbrel™. Specifically, prantiTNF binds TNF alpha thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNFinduced apoptosis in a dosedependent manner. In a proofofconcept in vivo study using an established arthritis animal model, prantiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model including joint inflammation, swelling and tissue degradation. Data from the collagen induced arthritis animal model studies are expected to be presented at an upcoming scientific conference.

“We are very encouraged by the preclinical data generated from our prantiTNF thus far,” said Dr. Yoseph Shaaltiel, Executive Vice President, R&D of Protalix. “These data further validate our ProCellEx™ technology and its ability to produce a wide range of complex therapeutic proteins in plant cells. Given our highly efficient and cost effective manufacturing process, we feel the Company is well positioned to be an active participant in the biosimilar market.”

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Most people think arthritis is worse in the cold, winter months but a dirty little secret is that it can be just as painful during the hot, summer months as well.

Paying close attention to your diet and exercising the right way can help minimize the pain. Flexcin International, Inc., a natural supplement company offering the only joint pain remedy products with CM8™, offers five great tips to control arthritis and joint pain during the summer months.

1) Activities like golf and even walking can be a good arthritis remedy because theyre great ways to loosen up the body and keep the joints from becoming sedentary.

2) Drink plenty of water and fluids to stay hydrated. Joint pain and arthritis often worsens as a result of dehydration.

3) People tend to consume more sugars from teas, sodas, sports drinks, cakes and pies in the summer. Too much sugar can actually be bad for arthritis and joints.

4) When traveling, make sure to stretch and get as much exercise and joint pain treatment as possible during stops. For car trips get out and walk around frequently and stretch as much as possible on long airplane rides.

5) With activities like gardening, avoid strenuous movements which can be taxing on joints. “Pain medications mask pain and cause further damage,” said Dr. Jan McBarron, M.D. N.D. and cohost of the nationally syndicated radio show, “Duke and the Doctor.” “Instead I recommend Flexcin, which helps build back the lost cartilage and lubricates your joints similar to how WD40 is used to lubricate the parts of an engine.”

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Obese people are four times as likely to develop osteoarthritis of the knee as they are to develop high blood pressure or type2 diabetes, according to a leading arthritis charity, launching a new online report on the subject. But whereas high blood pressure and diabetes may be substantially improved on losing weight and are relatively easy to control with therapy, the changes resulting from osteoarthritis are irreversible, as worn cartilage cannot currently be repaired.

However, according to Professor Alan Silman, medical director of the Arthritis Research Campaign, there is good news for the obese and overweight whose knees become painful due to osteoarthritis as a result of their weight.

“Research shows that losing weight, however modest, when combined with exercise, is a panacea at every stage,” said Professor Silman.

“Achieving a healthy weight reduces the risk of developing the disease in the first place, relieves existing symptoms and helps to prevent further deterioration. And weight loss and exercise has been shown to achieve the same level of symptom relief as joint replacement surgery.”

The medical research charity is concerned that while rising rates of obesity have been linked to a number of serious disorders and health concerns, the risk of potentially crippling osteoarthritis have been, if not ignored, then certainly underestimated.

The true impact of obesity in the development of knee osteoarthritis has only recently become clear, said the charity, pointing to a study which revealed that at the most extreme, very obese people with a body mass index of 36 or more have a 14fold higher risk of knee osteoarthritis compared to those in the healthy BMI range.

Professor Silman warned there was a real concern that unless rocketing rates of obesity were tackled, the numbers of people needing joint replacement surgery would soar, which would have a considerable impact on the NHS.

“There are two major risk factors for developing osteoarthritis ageing and obesity and as both these factors are on the rise in the UK, its an obvious prediction to make that the outcome could be a massive cost to the health service,” he added.

Joint replacements are more likely to fail earlier in obese patients, and the heavier the patients the less likely it is that surgery will bring about an improvement in symptoms.

Very obese women are 19 times more likely to need knee replacement and four times more likely to need hip replacement surgery compared to women of a healthy weight.

A series of studies have shown that even modest weight loss and exercise can help to reduce not only pain but also mobility and the ability to perform everyday activities.

Professor Silmans comments follow the publication of the charitys online report, Osteoarthritis and obesity, which warns the public of the hitherto little publicised dangers to their health and quality of life of obesity on their joints.

The Arthritis Research Campaigns report, Osteoarthritis and obesity, can be accessed on its website at arc.org.uk from July 15.

Newly announced National Institutes of Health (NIH) funding will expand the reach of ongoing University of Alabama at Birmingham (UAB) research into a unique nanostructured coating to improve the performance and longevity of total joint replacement components. The broadened UAB research opportunity is funded by a fouryear, $790,931 National Institutes of Health (NIH) grant through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

UABs research, titled Bioengineering Research Partnership (BRP) in Total Joint Replacements, will explore nextgeneration technology to improve the service life of total joint replacements, which UAB researchers believe could dramatically cut the number of recurrent surgical procedures performed each year, said Yogesh Vohra, Ph.D., the BRPs principal investigator and director of the Center for Nanoscale Materials and Biointegration (CNMB) in the UAB School of Natural Sciences and Mathematics.

Vohra said the BRP opportunity will unite his UAB interdisciplinary research team with professionals at Smith and Nephew Inc., an international leader in the development of advanced medical devices. The company is known globally for its OXINIUMTM oxidized zirconium material for joint replacements.

“We have been researching our nanostructured multilayer diamond coating for a number of years inside our UAB facilities but there have been limitations to just how rigorous the testing could be,” Vohra said. “The funding to partner with Smith and Nephew expands our research options because it offers us access to the companys resources and talent.”

Among the benefits, Vohra said, the BRP allows access to Smith and Nephews hip and knee simulators, which offer UAB researchers the most realistic testing conditions to date for their coating technology. Working with the multimillion dollar simulators should strongly indicate how well the teams nanostructured multilayer diamond coatings reduce the friction and wear on the metal components of orthopaedic devices, Vohra said. The team also will be able to examine the cellular and tissue responses to the technology and confirm that there is no toxicity effect from any wear debris that is generated.

“This partnership is central to advancing our research toward more reliable and efficient joint replacements,” Vohra said. “We are gaining access to stateoftheart testing equipment while benefitting from Smith and Nephews experience as the industry leader in advanced bearingsurfaces for joint replacement implants.”

The BRP also helps put the UAB coating technology on the fast track for commercialization, as it will foster the private industry relationship necessary to secure investment and production capacity, Vohra said.

The overall clinical impact of the BRP research is to drive down the number of recurrent surgical procedures for joint replacement recipients, who are living longer and pushing the longevity limits of their devices, Vohra said. The American Academy of Orthopaedic Surgeons reports that 15 to 20 percent of annual total joint replacement procedures are recurrent, or revision, surgeries. Vohra said the nanostructured diamondcoated devices should reduce the metal ion release to the surrounding tissues and perform better during longterm implantation in the human body, which could significantly cut the followup surgery rate.

The UAB interdisciplinary research team for the project includes Vohra, Susan Bellis, Ph.D., associate professor of physiology and biophysics, Aaron Catledge, Ph.D., research assistant professor of physics, Alan Eberhardt, Ph.D., associate professor of biomedical engineering and David Moore, M.D., Division of Orthopedic Surgery.

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Andrew Hayenga

POZEN Inc. (NASDAQPOZN), announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVO™ (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca entered into a global codevelopment agreement for VIMOVO in August 2006. Pending regulatory approval, the proposed trade name is VIMOVO and the proposed indications are for the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing NSAIDassociated ulcers.

The NDA submission is based on data from a comprehensive clinical trials program. POZEN conducted two pivotal studies (301/302) under a special protocol assessment agreed with the FDA, which met their primary endpoints. In the 301/302 studies, significantly fewer subjects taking VIMOVO experienced endoscopically confirmed gastric ulcers compared to subjects receiving EC naproxen. The primary endpoint was the cumulative incidence of gastric ulcers through six months. In each of the trials, approximately 400 subjects received either VIMOVO or EC naproxen (500 mg), twice daily, over a sixmonth treatment period. Subjects underwent upper endoscopies at baseline and at one, three, and six months. Upon the FDAs acceptance for filing of the NDA, a $10 million milestone payment from AstraZeneca will be payable to POZEN.

About Osteoarthritis

Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain, affecting nearly 140 million individuals worldwide,1 and impacting approximately 18% of women and 9.6% of men aged 60 and above.2,3 A combination of factors can contribute to osteoarthritis, including being overweight, aging, joint injury or stress, heredity and muscle weakness.4 Osteoarthritis commonly affects the hands, feet, spine or large weightbearing joints, such as the hips and knees.5 In the U.S., the average direct cost of osteoarthritis is about $2,600 per year outofpocket expenses. Total annual disease costs are $5,700 (2000) and jobrelated osteoarthritis costs are $3.4 to $13.2 billion per year.6

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