Phase III trials start

A board to discuss the soon-to-be released drug Campath as a treatment for Multiple Sclerosis

Phase III trials start

Postby bromley » Wed Sep 26, 2007 6:41 am

Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis 26 September 2007

Genzyme Corporation and Bayer Schering Pharma AG, Germany today announced that the first patient has been treated in the first of two planned Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).

The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomised, rater-blinded study, will compare alemtuzumab to Rebif(R) (interferon beta-1a) in patients with relapsing- remitting multiple sclerosis (MS). Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but who have not yet begun treatment with any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.

Initiation of this Phase 3 program follows the successful completion of the initial treatment period in the Phase 2 trial. Interim results from the Phase 2 trial indicated that alemtuzumab-treated patients experienced a statistically significant reduction compared with Rebif-treated patients in the risk for sustained accumulation of disability and the risk for relapse for 24 months. Results of the primary outcomes from this trial at 36 months are expected to be presented on Oct. 14 by Professor Alastair Compston during the Charcot Award lecture at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis, in Prague.

The CARE-MS I study will enroll up to 525 patients at approximately 60 medical centers throughout North America, Australia, Latin America, and Europe, and will again compare alemtuzumab-treated patients to Rebif-treated patients according to two co-primary endpoints: 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. All patients will be followed from their entry into the trial until two years from the date that the last patient is randomized to treatment. Alemtuzumab-treated patients will continue to have safety evaluations for at least three years after the last course of treatment. The companies anticipate filing for marketing approval of alemtuzumab for the treatment of MS in 2011.

Alemtuzumab is an investigational drug for the treatment of MS and must not be used outside of a formal clinical trial setting in MS patients. Physicians or patients seeking additional information about the CARE-MS I trial should contact Genzyme Medical Information at 1-800-745-4447, option 2 in the United States, + 31 35 6991499 in Europe

About Alemtuzumab

Alemtuzumab is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside of the U.S. for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The product was launched in its oncology indication in 2001 in the US, where it is marketed by Bayer HealthCare Pharmaceuticals Inc. as Campath(R), and in Europe, where it is named MabCampath(R).

Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces and directs the body's immune system to destroy those cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-CLL.

Genzyme and Bayer Schering Pharma AG, Germany are co-developing alemtuzumab in oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG, Germany holds exclusive worldwide marketing and distribution rights to alemtuzumab.

Campath has a boxed warning which includes information on cytopenias, infusion reactions, and infections. The most commonly reported adverse reactions in patients with B-CLL were infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.

Source: Genzyme Corporation and Bayer Schering Pharma AG, Germany (26/09/07)
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Postby ewizabeth » Wed Sep 26, 2007 10:01 am

Hi Bromley,

This one sounds promising. I think this is one my neuro is hopeful for, that, and CDP323. I haven't talked to him about any of the other up and coming treatments lately. These sure make the future treatment of MS look brighter.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby bromley » Wed Sep 26, 2007 11:17 am

Ewizabeth,

I'm thrilled with the benefits I have experienced to date. No relapses (not a whisper) since my infusion at the end of last November. I get my second infusion (3 days) at the end of this November. If anyone is thinking of participating in the Phase III trial I'd be more than happy to answer questions (pm me).

Hope the Tysabri is working out for you.

All the best

Ian
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Postby ewizabeth » Wed Sep 26, 2007 11:46 am

Ian,

I'd forgotten that you were in the Campath trial. I'm thrilled for you that you've had good results! :D

Tysabri is doing a good job for me so far. I have a bit more energy, and I think I might be gradually feeling a bit better as time goes on. I had my 5th infusion last week.

I'm finishing my BSBA degree right now, and in two very tough classes so I haven't posted a lot. I hope when I'm finished end of November I'll have lots of energy to do physical things around the house.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby CureOrBust » Thu Sep 27, 2007 12:56 am

ewizabeth, if I am not mistaken, Ian received Campath outside of any trial. I am glad to hear it is REALLY working out for him, and always have this treatment in the back of my head, in the compartment labelled jealousy. :)
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Postby bromley » Thu Sep 27, 2007 1:31 am

COB,

You are right - I am on a small project (I think 15 of us) which is not part of the Phase II trial. We all got the real thing.

Some further data on the Phase II trial is to be presented at ECTRIMS in early October, which I will post when I see it.

Ian
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