Roche, Genentech And Biogen Idec Announce Positive Results From First Phase III Trial Of Ocrelizumab In Rheumatoid Arthritis
Roche (SIX: RO, ROG; OTCQX: RHHBY), Genentech, Inc. a wholly owned member of the Roche Group, and Biogen Idec (Nasdaq: BIIB) announced a Phase III study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by American College of Rheumatology or ACR20 response) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks. The companies continue to analyze the study results and plan to submit the data for presentation at an upcoming medical meeting. "These results are significant because they are the first data from a large Phase III trial to show that a humanized antibody targeted at B-cells improves the signs and symptoms of rheumatoid arthritis, " said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. "These results build on earlier findings from our broad clinical program aimed at developing medicines to help people living with rheumatoid arthritis.
Independent Advisory Committee Recommends Continuation Of Phase III Oral Calcitonin Studies For Osteoporosis And Osteoarthritis
Unigene Laboratories, Inc. (OTCBB: UGNE) announced that an independent Data Monitoring Committee (DMC) has recommended that Novartis and its partner Nordic Bioscience proceed as planned with their ongoing oral calcitonin Phase III studies for osteoporosis and osteoarthritis. Its recommendation is based on the committee's recently completed "futility" analysis of the data obtained from all patients enrolled for at least twelve months in these studies. That analysis included an assessment of both safety and efficacy parameters. It is the committee's opinion that there are no major or unexpected safety concerns and it unanimously recommends to proceed with the studies to evaluate the efficacy and safety profile of oral calcitonin as planned. "The report of the DMC is an important benchmark in the conduct of these trials and it provides the first preliminary indication of the drug's performance, " commented Dr. Ronald S. Levy, Executive Vice President of Unigene Laboratories, Inc. "Unigene has a vested interest in the success of these studies both from a milestone and a royalty perspective, and we are encouraged by this committee's recommendation.
Winston Laboratories, Inc. Receives Notice Of Non-Compliance In Canada For Its New Drug Submission Of CIVANEX To Treat Osteoarthritis
Winston Laboratories, Inc. ("Winston Labs"), a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. (OTC BB: WPHM) today announced that it has received a Notice of Non-compliance ("NON") from the Therapeutics Drug Directorate, Health Canada (the "Directorate") for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis. The Directorate remarked that the analysis of the pivotal trial did not support the requested indication. Winston Labs has a period of ninety days to submit a response to the Directorate's NON, which it intends to do. "Winston Labs intends to fully address the comments in the NON, and believes that the clearly favorable risk-benefit profile of CIVANEX should lead to approval in Canada, " stated Joel E. Bernstein, MD, President and Chief Executive Officer of Winston Pharmaceuticals, Inc. "We believe CIVANEX represents an advance over current topical therapies for osteoarthritis as it is not absorbed, and thus has minimal risk for systemic side effects or interactions with other medications a patient might be using.
Updated Data From Randomized Controlled Phase II Study Evaluating Oral Apremilast In Psoriatic Arthritis Demonstrates Sustained Response At Six Months
Celgene Corporation (NASDAQ: CELG) announced that updated results of a phase II, multi-center, randomized, double-blind, placebo-controlled, three-arm study of apremilast in adult patients with psoriatic arthritis (CC-10004-PSA-001) were presented today at the American College of Rheumatology (ACR) 2009 annual meeting in Philadelphia, PA. Apremilast is an oral pluripotent immunomodulator that inhibits the activity of PDE4 and modulates the production of multiple pro-inflammatory mediators, including TNF-Î, IL-2 IL-10, IL-17, and IL-23. CC-10004-PSA-001 sought to determine the efficacy and safety of apremilast in 204 patients at two different dosing regimens - 20mg twice per day (BID) or 40mg once per day (QD) compared to placebo after 12 weeks, with 126 patients participating in an extension of the study for an additional 12 weeks (24 weeks total). Approximately 60 patients did not have the opportunity to participate in the extension due to the timing of its initiation. The extension included 40 patients that had previously received placebo and were randomized to receive one of the two dose regimens of apremilast.
An important assay used to aid in the diagnosis of rheumatoid arthritis (RA) will soon be available on Abbott's ARCHITECT immunoassay analyzers. The FDA has granted 510(k) clearance for an antibody cyclic-citrulinated peptide, or anti-CCP assay, to run on the world class systems. Many patients with RA develop an immune response against proteins containing citrulline long before they present symptoms of the disease. Studies show detecting the level of these antibodies earlier in the disease continuum, in conjunction with other clinical information, is critical to the early diagnosis of the disease. The American College of Rheumatology treatment guidelines for RA recommends early diagnosis of the disease and timely introduction of therapies to prevent potentially irreversible joint damage. The assay was developed by Axis-Shield to run on Abbott's ARCHITECT i1000SR and i2000SR systems. The anti-CCP assay is already approved and available on the Abbott ARCHITECT outside the United States.
Chicken collagen can provide relief from rheumatoid arthritis (RA) symptoms. A randomised, controlled trial, published in BioMed Central's open access journal Arthritis Research & Therapy, has found that Chicken type II collagen (CCII), a protein extracted from the cartilage of chicken breast, is a safe and effective treatment for RA. Wei Wei, from Anhui Medical University, China, worked with a team of researchers to test the novel treatment by comparing it to the established antirheumatic drug methotrextate, in 503 RA patients. Patients who received a 12-week course of CCII capsules showed significantly improved joint function, with fewer and milder adverse effects than those taking methotrexate. According to Wei, "We've shown that CCII is a promising alternative therapeutic strategy that may be used as a nutritional supplement against rheumatoid arthritis". RA is an autoimmune disease caused by the body mounting a response against its own cartilage - the rubbery tissue, composed mainly of collagen, which cushions and lubricates joints.
Biogen Idec (NASDAQ: BIIB) today announced that its oral compound BG-12 (dimethyl fumarate) achieved key milestones in clinical trials for multiple sclerosis (MS) and rheumatoid arthritis (RA). In recent months, the last patient was enrolled in the CONFIRM trial, the second of two Phase III trials designed to evaluate the efficacy and safety of BG-12 as a monotherapy in patients with relapsing-remitting multiple sclerosis (RRMS). Both the DEFINE and CONFIRM Phase III trials are now fully enrolled and will evaluate the effect of BG-12 on clinical relapse, disability progression, various MRI measures of disease activity, and safety. The last patient was also enrolled in a Phase II study to evaluate the safety, tolerability and efficacy of BG-12 in combination with methotrexate in subjects with active RA who had an inadequate response to conventional disease-modifying antirheumatic drug (DMARD) therapy. "There is significant unmet need in both the MS and RA communities for additional treatment options, " said Kate Dawson, M.
Neovacs Initiates A Phase II Clinical Trial Of TNF-alpha Kinoid In Rheumatoid Arthritis Patients Failing TNF-alpha Monoclonal Antibody Therapy
Neovacs, a biotechnology company developing proprietary immunotherapies for autoimmune and chronic diseases, today announced the initiation of a Phase IIa clinical study of its TNFÎ Kinoid immunotherapy in rheumatoid arthritis patients who have ceased to respond to an anti-TNFÎ monoclonal antibody and who test positive for anti-drug antibodies (ADAs). The announcement follows trial clearance by the French regulatory authority (AFFSAPS) and the central ethics committee. Neovacs has also submitted the trial protocol to the relevant authorities in two other European countries and has already received regulatory clearance in one and ethics committee approval in the other. "This is a major milestone and an excellent way to end 2009 - a year that has seen Neovacs make significant progress", stated Guy-Charles Fanneau de la Horie, CEO of Neovacs, "Along with the ongoing Phase Ib trial in Crohn's patients, this new Phase IIa trial adds a second indication for our TNF-Kinoid. We also plan to initiate clinical testing of our second product, IFNÎ Kinoid, in early 2010".
A comprehensive account of the most important advances in rheumatology research from the past decade has been published in BioMed Central's open access journal Arthritis Research and Therapy (AR&T). This freely available collection of 38 articles written by an internationally recognized group of experts spanning more than 400 pages is an essential educational tool which provides clinicians and researchers with a detailed overview of the current status of basic, translational and clinical research in rheumatology. Rheumatic diseases affect the body's joints, muscles, skin and a variety of internal organs and connective tissues. Current estimates indicate that some 43 million Americans have been diagnosed to date as well as even greater numbers worldwide. AR&T's new review collates the expertise of 39 renowned scientists and rheumatologists to present physicians and scientists around the globe with an invaluable reference work outlining the biologic processes underlying rheumatic diseases and analyzing the most significant developments in specific rheumatic diseases from the past decade.
Middle-aged men and women who engage in high levels of physical activity may be unknowingly causing damage to their knees and increasing their risk for osteoarthritis, according to a study presented today at the annual meeting of the Radiological Society of North America (RSNA). "Our data suggest that people with higher physical activity levels may be at greater risk for developing knee abnormalities and, thus, at higher risk for developing osteoarthritis, " said Christoph Stehling, M.D., research fellow in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco (UCSF) and radiology resident in the Department of Clinical Radiology, University of Muenster, Germany. Osteoarthritis is a degenerative joint disease that causes pain, swelling and stiffness. According to the Centers for Disease Control and Prevention, osteoarthritis is the most common form of arthritis and affects an estimated 27 million American adults. The UCSF study involved 236 asymptomatic participants who had not reported previous knee pain and were enrolled in the National Institutes of Health Osteoarthritis Initiative.