Opexa Therapeutics Launches Tovaxin(TM) Clinical Trial Website for Multiple Sclerosis 15 February 2007
Opexa Therapeutics, Inc, a company involved in the development and
commercialization of cell therapies, today announced that it has launched an information website for its Phase IIb study of Tovaxin(TM) ("TERMS" study) located at www.tovaxin.com
The TERMS study is being conducted at 35 U.S. sites to evaluate the safety and effectiveness of the investigational T-cell vaccine, Tovaxin, for the treatment of multiple sclerosis. The site includes information for prospective trial participants and supplements the clinical trial registration information on the U.S. National Institutes of Health-sponsored website, www.clinicaltrials.gov
, where pharmaceutical companies are required to register trials for medicines that will treat serious or life-threatening diseases or conditions.
David McWilliams, president and chief executive officer of Opexa, commented, "Given the strong interest in our Tovaxin Phase IIb clinical trial, we felt compelled to create a website that provides information to prospective patients and their families. We look forward to using this site for future trials and into commercialisation."
The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomised, 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 annualised 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.
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