How can Tcelna (formerly Tovaxin) help people with multiple sclerosis (MS)?

Tovaxin, now known as Tcelna or imilecleucel-T, a medication for the treatment of people with secondary­progressive multiple sclerosis (SPMS) has been granted fast-track designation by the U.S. Food and Drug Administration (FDA). Tcelna is a personalized cellular immunotherapy treatment that is in late stage clinical development for multiple sclerosis (MS). It is prepared from a sample of the person’s own cells. Myelin­reactive T­cells are extracted from the blood and irradiated to produce a vaccine. When injected, the vaccine triggers a potent immune response against specific subsets of autoreactive T­cells known to attack myelin and thereby reduces the risk of relapse over time, according to the drug’s developer, Opexa Therapeutics. “People with progressive forms of multiple sclerosis are faced with no proven effective treatment options, so the fast-track designation for Tcelna is meaningful as it should enable Tcelna to move more rapidly through the regulatory process, once it is proven to be efficacious,” commented Mark Freedman, MD, 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 Tcelna offer hope for people with a diagnosis of progressive MS.”

Opexa reports it is planning to initiate a phase IIb clinical trial with Tcelna in SPMS subject to securing the necessary resources, while remaining committed to further advancing Tcelna in relapse-remitting MS (RRMS) at a later date.

Says Multiple Sclerosis Foundation Senior Medical Advisor Ben Thrower, MD, “Tcelna is exciting in that it could be a truly ‘customized’ therapy for people with SPMS. This vaccine is made from the person’s own T­cells and can be repeated over time to account for any changes in the underlying immune attack on myelin. We know that how MS works may vary immunologically from one person to the next. Having a therapy that is unique to that person’s MS would represent a major step forwards.”

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