TOVAXIN: Opexa Begins Dosing Patients in Phase IIb Trial of Tovaxin for MS
"Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company involved in the development and commercialization of cell therapies, announced today that it has dosed the first patient in its 150-patient Phase IIb clinical trial of Tovaxin™ in multiple sclerosis. Enrollment is expected to be completed by mid-2007. There are currently 31 trial sites in the U.S., all of which are actively recruiting patients; the first patient was treated by Dr. Suzanne Gazda, Principal Investigator at Integra Clinical Research in San Antonio, Texas.

As previously announced, this Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) and relapsing-remitting MS (RR-MS) patients. A total of 100 patients will receive Tovaxin, while 50 will receive placebo. The study is designed as a two-arm, 52-week, parallel-group study, whereby patients will be given five subcutaneous injections at 0, 4, 8, 12 and 24 weeks. The analyses will be performed at the end of the 52-week study to assess the safety and efficacy of Tovaxin. The primary efficacy variable is the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans summed over the Week 28, 36, 44, and 52 MRIs. The secondary efficacy variables are the cumulative number of new gadolinium-enhancing lesions at Weeks 28-52, the change in T2-weighted lesion volume, and the annualized relapse rate.

All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.

David McWilliams, president and chief executive officer of Opexa, commented, “We have received a very enthusiastic More on Opexa Therapeutics Home Page