CAMBRIDGE, Mass. --Genzyme Corporation today announced that five-year patient follow-up data from its completed Phase 2 multiple sclerosis (MS) trial will be presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden, October 13-16, 2010. In addition to this long-term data, Genzyme will present new alemtuzumab mechanism of action research as well as additional results from the company’s alemtuzumab multiple sclerosis (MS) development program.
Alemtuzumab is a humanized monoclonal antibody being studied as a potential therapy for relapsing-remitting multiple sclerosis (RRMS). Genzyme is currently conducting two pivotal Phase 3 trials to evaluate alemtuzumab in the treatment of MS. CARE-MS I is a randomized trial comparing alemtuzumab to the approved MS therapy Rebif® (high dose interferon beta-1a) in early, active RRMS patients who have received no prior therapy. CARE-MS II, which also compares alemtuzumab to Rebif, is studying RRMS patients who relapsed while on other MS therapies
“The ten ECTRIMS alemtuzumab presentations speak to the excitement surrounding alemtuzumab and the potential it holds as an MS treatment,” said Michael Panzara, Genzyme Group Vice President and Therapeutic Area Head for Multiple Sclerosis and Immune Diseases.
Genzyme’s CAMMS223 Phase 2 trial, first reported in the New England Journal of Medicine in 2008, compared alemtuzumab to Rebif in early, active, RRMS patients who had received no prior therapy. In the trial, which was larger and longer than most Phase 2 MS clinical trials, alemtuzumab was given to patients in two or three annual cycles of not more than five days per cycle, while Rebif was given to patients three times per week, every week for three years.
Alemtuzumab Data to Be Presented At ECTRIMS:
• Alemtuzumab Long-term Safety and Efficacy: Five Years of the CAMMS223 Trial (Poster 410, October 14)
• Alemtuzumab for Relapsing-Remitting Multiple Sclerosis: CARE-MS I Baseline Demographics and Disease Characteristics (Poster 454, October 14)
• Efficacy of Alemtuzumab in Highly Active Relapsing-Remitting Multiple Sclerosis Patients in CAMMS223 (Poster 429, October 14)
• Disability Progression-Free Efficacy of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients in CAMMS223 (Poster 426, October 14)
• Alemtuzumab’s Efficacy in CAMMS223 as Assessed with the Multiple Sclerosis Severity Score (Poster 428, October 14)
• Analysis of EDSS Measurements from CAMMS223: Application of a Markov Transition Model for Repeated Ordinal Data (Poster 404, October 14) • Case Report of Anti-Glomerular Basement Membrane Disease Following Alemtuzumab Treatment (Poster 421, October 14)
• Analysis of immune competence following alemtuzumab treatment in huCD52 transgenic mice (Poster 427, October 14)
• Impact of Alemtuzumab Treatment on the Survival and Function of Human Regulatory T-cells in vitro (Poster 424, October 14)
• Differential Sensitivity of Human Peripheral Blood Mononuclear Cell Subsets to Alemtuzumab-Mediated Cytotoxicity (Poster 425, October 14)
About Alemtuzumab
Alemtuzumab is a humanized monoclonal antibody being studied as a potential therapy for RRMS. Alemtuzumab targets the cell-surface glycoprotein CD52, which is often expressed on T- and B-lymphocytes. Research suggests that alemtuzumab depletes the T- and B-cells that may be responsible for the cellular damage in MS, while sparing other immune system elements. Alemtuzumab research has also demonstrated a unique pattern of lymphocyte reconstitution in patients following treatment with the drug.
Two pivotal Phase 3 studies investigating alemtuzumab, CARE-MS I and II, are currently ongoing. Data from these trials are expected to be available in 2011. The company expects to file for U.S. and E.U. approval in early 2012, and has been granted fast track status by the FDA for this submission.
About CAMMS223 Phase 2 Study
In the Phase 2 trial, 334 patients with early active RRMS were randomized to treatment with alemtuzumab at one of two dose levels, or Rebif. The majority of patients last received alemtuzumab at Month 12. Patients were strongly encouraged to continue for two additional years of follow-up beyond the original three years of the study.
As previously reported, notable adverse events associated with alemtuzumab in CAMMS223 included mild to moderate infusion-associated reactions, mild to moderate infection and autoimmunity (primarily thyroid disorders and immune thrombocytopenia). Patient monitoring for thyroid disorders, ITP, and anti-GBM disease is incorporated into all Genzyme-sponsored trials of alemtuzumab for the investigational treatment of MS.
Since it is not yet approved for the treatment of MS, alemtuzumab must not be used in MS patients outside of a formal, regulated clinical trial setting in which appropriate patient monitoring measures are in place.
About Genzyme
One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and immune disease. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need.
This press release contains forward-looking statements regarding Genzyme’s future plans and business strategies, including: its expectations about when data will become available from the two phase 3 trials, the anticipated date of regulatory approval for alemtuzumab, and the success of alemtuzumab to treat MS. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements, including: the timing and outcome of the data from the phase 3 trials; that the phase 3 trials may not be successful; the timing and outcome of discussions with the regulatory agencies regarding approval of alemtuzumab for MS; the actual safety and efficacy of alemtuzumab for MS; and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading “Risk Factors” in Genzyme’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2010. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.
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