On November 8, 2011, the FDA granted the drug Tovaxin a "Fast Track" designation. When a drug is designated by the FDA as Fast Track, the review process for the drug is expedited. Ultimately, this means getting the drug approved and to market sooner. Tovaxin is being developed for the treatment of patients with Secondary Progressive Multiple Sclerosis.
For the over 6,000 Connecticut residents (and 400,000 Americans) battling the potentially debilitating effects of multiple sclerosis (MS), this offers hope for a new and effective therapy. "Patients with progressive forms of MS are faced with no proven effective treatment options, so the Fast Track designation for Tovaxin is meaningful as it should enable Tovaxin to move more rapidly through the regulatory process," said Mark Freedman, M.D. of the University of Ottawa.
Multiple sclerosis is an autoimmune disease that affects the central nervous system (i.e., the brain and spinal cord). Secondary Progressive MS is characterized by a steady accumulation of irreversible disability. There is no known cure for MS. The goal of current treatment is to control symptoms and try to slow the disease down.
Tovaxin is a T-cell vaccine for the treatment of MS that is specifically tailored to each patient's disease profile. It is designed to reduce the number of specific subsets of autoreactive T-cells known to attack myelin. Thus, it is specific for the immune response against the myelin-destroying T cells and should not cause a general immunosuppression.
Based on this positive FDA milestone and the recent encouraging data with Tovaxin in SPMS, Opexa Therapeutics, Inc. (the maker of Tovaxin) is initiating a Phase IIb clinical trial with Tovaxin in SPMS. Tovaxin is also being considered for the treatment of patients with Relapsing Remitting MS. Information about future clinical trials will be available on Opexa's website.
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