FDA grants Fast Track designation to Opexa's Tovaxin for treatment of SPMS

Nov 8 2011

Opexa Therapeutics, Inc. (NASDAQ: OPXA), announced today that its lead drug candidate Tovaxin^® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS).

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. According to the FDA, products with a Fast Track designation often receive priority review, which may offer a significant benefit in that, historically, the review time of a priority product is almost half that of a standard review. Additionally, as per the FDA, Fast Track priority review products are more likely to be approved on the first review cycle than those without the designation. Fast Track also entitles Opexa to more frequent interactions and dialogue with the FDA, further benefiting the development of Tovaxin.

"Patients with progressive forms of multiple sclerosis (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, once it is proven to be efficacious," commented Dr. Mark Freedman, M.D., FRCP, FAAN, Professor of Medicine at the University of Ottawa and Director of the Multiple Sclerosis Research Unit at the Ottawa Hospital. "Novel therapies such as Tovaxin offer hope for patients with a diagnosis of progressive MS."

"The receipt of Fast Track designation from the FDA represents an important step in our strategy to advance Tovaxin through the clinical and regulatory process," said Neil K. Warma, President & Chief Executive Officer of Opexa. "We look forward to working closely with the FDA throughout the process as we recognize the need to develop a new, efficacious therapy to serve Secondary Progressive MS patients and realize the benefit Tovaxin could offer. Based on this positive FDA milestone, our encouraging data in SPMS and supportive discussions with key opinion leaders, clinicians and patients, we have accelerated our plans for SPMS and are planning to initiate a Phase IIb clinical trial with Tovaxin in SPMS subject to securing the necessary resources, while remaining committed to further advancing Tovaxin in Relapsing Remitting MS at a later date. For Opexa, moving forward in progressive MS, an area which we believe represents a higher unmet medical need, could further differentiate the company and Tovaxin from other MS treatments."

SPMS is characterized by a steady accrual of irreversible disability, despite, in some cases, reversible relapses, remissions, or clinical plateau. Only one product is currently approved in the United States specifically for the indication of SPMS. Opexa believes that a significant unmet medical need exists for the safe and effective treatment of SPMS.