Genzyme, a subsidiary of sanofi-aventis Group announced that it will present new data from its completed phase II trial of the investigational drug Alemtuzumab for Multiple Sclerosis (MS) at the American Academy of Neurology's (AAN) 63rd Annual Meeting in Hawaii, April 9 - 16, 2011. Included among the additional phase II trial safety and efficacy data at AAN will be presentations on the clinically-active disease status of patients through five-years of patient follow-up as well as data describing a measure of vision improvement.

“We are excited to present new alemtuzumab data at AAN that further reflects alemtuzumab's potential as an MS treatment,” said Michael Panzara, Genzyme Group vice president and Therapeutic Area Head for Multiple Sclerosis and Immune Diseases. “We look forward to the availability of phase III results in the middle of this year.”

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 III 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. Data from these trials are expected to be available beginning in mid-2011.

Genzyme’s CAMMS223 phase II 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 II 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.  The study included an extended phase for collection of long-term efficacy and safety data.

Alemtuzumab targets the cell-surface glycoprotein CD52, which is often expressed on T- and B-lymphocytes. Preliminary research suggests that it depletes the T- and B-cells that may be responsible for the cellular damage in MS, while potentially sparing other cells of the immune system. Early research has also suggested a distinctive pattern of lymphocyte reconstitution in patients following treatment.

In the phase II trial, 334 patients with early active relapsing-remitting multiple sclerosis were randomized to treatment with alemtuzumab at one of two dose levels, or to the approved MS therapy Rebif (high dose interferon beta-1a). 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. The majority of alemtuzumab treated patients last received the investigational drug at Month 12.

The trial successfully met its two primary endpoints, reduction in relapse rate and reduction in the rate of sustained accumulation of disability.

Patients were strongly encouraged to continue for two additional years of follow-up beyond the original three years of the study. Sixty-eight percent of alemtuzumab patients participated in the follow-up programme, and 60 percent were evaluated at 60 months. Forty-two percent of Rebif patients participated in the follow-up program, and 35 percent were evaluated at 60 months. Rater-blinded disability scores were assessed quarterly and relapses as-needed. A sensitivity analysis adjusted for patients receiving alternative disease-modifying therapy during the follow-up period, as well as for retreatment with alemtuzumab.

As previously reported, common adverse events associated with alemtuzumab in the CAMMS223 phase II trial included mild to moderate infusion-associated reactions, secondary autoimmunity (primarily thyroid disorders and immune thrombocytopenia), and infections, particularly of the upper respiratory tract; infections were predominantly mild to moderate in severity and there were no life-threatening or fatal infections. Approximately 30 percent of alemtuzumab-treated patients developed an autoimmune thyroid-related adverse event. Thyroid disorders were managed using conventional therapies. 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.

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