Brief Campath update
Posted: Wed Jan 10, 2007 8:44 am
A blurb about Campath from a Genzyme press release today:
Following an encouraging meeting with the FDA in November, Genzyme expects to initiate during the first half of this year a phase 3 study of alemtuzumab (Campath) for the treatment of relapsing/remitting multiple sclerosis. The company is currently developing the study protocol to submit to the agency for review. Two-year results from a pre-planned interim analysis of the three-year phase 2 study were released in September and showed a robust, statistically significant treatment effect for alemtuzumab compared with Rebif(R) (interferon beta-1a). The IND for this trial remains on clinical hold in the United States, and Genzyme is working closely with clinical investigators and regulatory agencies to complete the study and ensure that the risk of immune thrombocytopenic purpura (ITP) is well understood and managed. Genzyme has implemented a comprehensive risk management plan to help physicians and patients participating in the trial detect ITP early and minimize the risk of complications.
http://www.drugnewswire.com/11163/
Following an encouraging meeting with the FDA in November, Genzyme expects to initiate during the first half of this year a phase 3 study of alemtuzumab (Campath) for the treatment of relapsing/remitting multiple sclerosis. The company is currently developing the study protocol to submit to the agency for review. Two-year results from a pre-planned interim analysis of the three-year phase 2 study were released in September and showed a robust, statistically significant treatment effect for alemtuzumab compared with Rebif(R) (interferon beta-1a). The IND for this trial remains on clinical hold in the United States, and Genzyme is working closely with clinical investigators and regulatory agencies to complete the study and ensure that the risk of immune thrombocytopenic purpura (ITP) is well understood and managed. Genzyme has implemented a comprehensive risk management plan to help physicians and patients participating in the trial detect ITP early and minimize the risk of complications.
http://www.drugnewswire.com/11163/