Genzyme and Bayer have initiated Phase III trials of B-cell chronic lymphocytic leukemia therapy Campath (alemtuzumab) in the treatment of multiple sclerosis, the companies announced Sept. 26.

The randomized, rater-blinded CARE-MS SM I study will compare alemtuzumab to Serono's Rebif (interferon beta-1a) in patients with relapsing-remitting MS who have been diagnosed but have not yet begun treatment.

A second trial, CARE-MS II, will begin soon in patients who have continued to experience relapse episodes while on currently available disease-modifying therapies, the firms said.

CARE-MS I will enroll up to 525 patients at approximately 60 sites in North America, Australia, Latin America and Europe.

The co-primary endpoints of the trial are the time to sustained accumulation of disability and the annualized relapse rate.

Alemtuzumab will be dosed at 12 mg/day for five days by daily IV infusion, with a second dosing 12 months later of 12 mg/day for three days. Campath will be given in two annual cycles, and Rebif will be administered three times a week

All patients will be followed for two years from the date the last patient is randomized to treatment, and alemtuzumab patients will be monitored for at least three years after the last course of treatment.

Interim results from the Phase II Campath trial, slated to be presented Oct. 14 at the European Committee for Treatment and Research in Multiple Sclerosis, indicated that alemtuzumab-treated patients experienced a statistically significant reduction in the risk for sustained accumulation of disability and the risk for relapse for 24 months, compared with Rebif-treated patients.

The firms said they will likely file the product in 2011, setting up a 2012 launch timeframe.

The companies have run into several delays in the development of Campath in MS. Genzyme had previously said it was aiming for a 2009 launch based on positive preliminary Phase II study results (¹ Also see "Genzyme Plans Campath MS Launch In 2009" - Pink Sheet, 28 September, 2006.).

In September 2005 dosing in the Phase II study was halted after three cases of immune thrombocytopenic purpura were reported, the first of which resulted in a death.

The delay in launch could prove costly for Genzyme and Bayer, as a number of other companies are charging ahead with new MS therapies.

Novartis, for example, is developing the first oral treatment; the company plans to submit FTY720 (fingolimod) in 2009 (² Also see "Race To Develop Oral MS Therapy Heats Up As Novartis Releases Data Results" - Pink Sheet, 28 September, 2006.).

Biogen Idec also is evaluating an oral treatment, BG-12, in Phase III for relapsing-remitting MS. The company announced in mid-2006 it was seeking to have five MS products on the market (³ Also see "Biogen Idec Plans Multiple Sclerosis Portfolio Expansion" - Pink Sheet, 26 July, 2006.).

Biogen markets Avonex (interferon beta-1a) and Tysabri (natalizumab), and is co-developing daclizumab (Roche's Zenapax ) for relapsing forms of MS with PDL BioPharma. In addition, the company is working with Genentech to investigate Rituxan (rituximab) as a treatment for relapsing-remitting MS.

The announcement regarding the Campath MS study comes less than a week after Genzyme and Bayer reported they had received FDA approval of a supplemental BLA allowing Campath labeling to include an indication for first-line treatment of B-cell chronic lymphocytic leukemia (⁴ Also see "Genzyme/Bayer Get FDA Approval For Campath As First-Line Treatment In Lymphocytic Leukemia" - Pink Sheet, 20 September, 2007.).

The drug is the first monoclonal antibody approved for the treatment of B-CLL. It was approved in 2001 for patients who had been treated previously with alkylating agents and who had failed treatment with fludarabine.

-Brooke McManus (b.mcmanus@elsevier.com)

Genzyme Initiates Campath Phase III Study In Multiple Sclerosis

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