Patients participating in the study will receive 52 weeks of treatment and will undergo safety and efficacy assessments using primary criterion of gadolinium-enhancing lesions and secondary criterion of annualized relapse rate.
David McWilliams, president and CEO of Opexa Therapeutics, said: “Full enrollment in this phase IIb study is an important milestone in the commercialization of Tovaxin. With this milestone achieved, we now look forward to reporting a descriptive analysis in the fourth quarter of 2007 and the full data results in the second half of 2008.”
In multiple sclerosis, a protective insulating sheath around the nerve fibres in the white matter regions of the central nervous system called myelin is damaged in an inflammatory response by the body's own immune system. This causes a wide variety of neurological symptoms that vary considerably depending on which areas are damaged.
Tovaxin is a novel T-cell therapeutic vaccine consisting of attenuated autoreactive T cells which elicits an immune response directed against T cells within the patient that are self-reactive with myelin. According to Opexa, Tovaxin has considerable potential because it attacks the underlying cause of MS rather than just addressing its symptoms.