08-01-2001, 11:45 AM
Dr Y. about 2.5-3 months ago in a thread at cantdo you eluded to acorde gearing up to start a phase 1 clinical trial with M1 in MS pts. i was wondering if you could elaborat on were acorda was with M1.
08-01-2001, 12:34 PM
Acorda made much more progress with M1 than anybody ever antipated. M1 was originally a mouse antibody (like IN-1 was). Instead of going the route of "humanizing" the mouse antibody so that it could be used in a human, Acorda (e.g. Moses Rodriguez at Mayo Clinic) invested in finding the actual human M1. They found the antibody, developed the procedure for making it in quantity.
The plan is to start the trial, probably early in 2002, first in people with MS. This is of course assuming that the FDA approves the protocol. Details of clinical trial are often not announced until the last moment because the company must get the protocol approved by the FDA. Sometimes the FDA will require all sorts of changes in the trial design.