This study makes the suggestion that Copaxone could very well be useful as a treatment for Primary Progressive Multiple Sclerosis, particularly in men. However, there was a (strangely enough) low rate of progression in both the placebo and the drug groups, and so statistical significance was not reached. Still, this bodes well for PPMS'ers who until now really have had no sanctioned CRAB treatment choice (Novantrone is approved for PPMS, and anecdotally Low Dose Naltrexone has shown efficacy in this subgroup as well).
"Treatment with COPAXONEŽ (glatiramer acetate injection) may provide beneficial effects in patients with primary progressive multiple sclerosis (PPMS), according to new data presented late yesterday at the 56th Annual Meeting of the American Academy of Neurology. In a post-hoc analysis of all available data from the intention-to-treat cohort, men treated with COPAXONEŽ were found to have significantly slower rates of progression of the disease than those treated with placebo. No overall benefit was shown, a result that may have been driven by the low rate of progression in the study population. "
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COPAXONE(R) Study Demonstrated a Trend in Affecting Clinical Progression of Primary Progressive Multiple Sclerosis
Slower Rates of Progression Noted for Men
KANSAS CITY, MO -- (MARKET WIRE) -- 04/28/2004 -- Treatment with COPAXONEŽ (glatiramer acetate injection) may provide beneficial effects in patients with primary progressive multiple sclerosis (PPMS), according to new data presented late yesterday at the 56th Annual Meeting of the American Academy of Neurology. In a post-hoc analysis of all available data from the intention-to-treat cohort, men treated with COPAXONEŽ were found to have significantly slower rates of progression of the disease than those treated with placebo. No overall benefit was shown, a result that may have been driven by the low rate of progression in the study population.
The primary progressive form of multiple sclerosis is the most degenerative form of MS, characterized by a slow (nearly continuous) worsening of symptoms from the onset of the disease. It is a relatively rare form of the disease, occurring in about 10 percent of multiple sclerosis patients and more typically occurs in men. Unlike the more common relapsing-remitting form of the disease, it is not associated with distinct relapses or periods of remission. No currently available treatments have shown significant positive effects in treating PPMS.
"Although the primary endpoint in our trial did not reach statistical significance, there was a trend with COPAXONEŽ to slow clinical progression," said Dr. Jerry S. Wolinsky, Bartels Family Professor of Neurology, The University of Texas Health Science Center at Houston. "We observed slower rates of progression in men on the drug. Based on these findings, additional research with COPAXONEŽ in PPMS is warranted."
The data are from an intent-to-treat analysis of the ProMiSe trial in which 943 patients (455 men) were randomized for treatment with COPAXONEŽ (glatiramer acetate injection) or placebo in a two-to-one ratio. A preplanned interim analysis of 935 patients, of whom 757 had completed at least two years or had terminated the study early, projected that no significant treatment effect could be reached for the primary endpoint, which was time to progression of Expanded Disability Status Scale (EDSS) scores (defined as change of 1.0 EDSS point or greater for entry EDSS of 3.0 - 5.0, or 0.5 for entry EDSS of 5.5 - 6.5). As a result, the study was terminated prematurely and study medications were discontinued.
Despite the termination of this study, due to the unique nature of this PPMS cohort, patients were offered the opportunity to continue to be followed. An intention-to-treat analysis at three years demonstrated trends toward delaying disease progression and decreasing the proportion of male patients demonstrating progression in favor of COPAXONEŽ. The Kaplan Meier survival curve indicated delayed disease progression for males assigned to COPAXONEŽ diverged from a placebo-assigned patient curve within a year of study entry, and the gap widened over time. Additionally, an analysis of an on-study drug cohort supported a treatment effect based on MRI-monitored enhancements and plaque burden. Overall, data suggested COPAXONEŽ had a beneficial impact on clinical progression, most evident in the subcohort of male patients where the placebo group showed more rapid progression.
"It is unfortunate the premature discontinuation of study medication and unanticipated low event rate complicate the interpretation of this trial," said Dr. Wolinsky. "Most sensitivity subcohort analyses supported or strengthened the primary analysis, suggesting a trend toward delaying disease progression with COPAXONEŽ."
COPAXONEŽ is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. The most common side effects of COPAXONEŽ are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONEŽ (glatiramer acetate injection) is now approved in 42 countries worldwide, including the United States, Canada, Australia, Israel, and all the European countries. In Europe, COPAXONEŽ is marketed by Teva Pharmaceutical Industries Ltd., and Aventis Pharma. In North America, COPAXONEŽ is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 pharmaceutical companies in the world. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Close to 90 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONEŽ.
See additional important information at http://www.copaxone.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.
COPAXONEŽ is a registered trademark of Teva Pharmaceutical Industries Ltd.
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, including its recent acquisition of Sicor Inc., the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
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