Tcelna is being developed by Opexa Therapeutics as a personalized T-cell immunotherapy for people with secondary progressive multiple sclerosis (SPMS). It is an autologous T-cell vaccine containing autoreactive T-cells. Such a concept is comparatively new in the pharmaceutical industry and for this reason, and because SPMS has a great unmet medical need, the U.S. Food and Drug Administration(FDA) has granted Tcelna fast-track status to help speed its clinical development.
How Tcelna Works
Tcelna is specifically tailored to each patient’s immune response profile to myelin, and it is designed to reduce the number and/or functional activity of specific subsets of myelin-reactive T-cells (MRTC) that are known to attack myelin. The company manufactures Tcelna using its proprietary ImmPath technology, a method of creating a T-cell immunotherapy from a person’s blood that encompasses the isolation of peripheral blood mononuclear cells, the generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG), and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. The attenuated T-cells are reintroduced via subcutaneous injection to trigger a therapeutic immune system response.
History of Tcelna
Five clinical trials have been completed with Tcelna in 356 patients, many with multiple years of treatment, the company reported. According to those studies, Tcelna demonstrated a potential to reduce the Annualized Relapse Rate (ARR) in MS patients and to slow disease progression. Evidence of an improvement in disability was also seen in a number of patients, suggesting a neuroprotective benefit.
A Phase 2 double-blind and placebo-controlled study in 180 SPMS patients, that began in 2012, is expected to conclude in August 2016. Its primary endpoint is change in brain volume (atrophy) at 24 months as measured by magnetic resonance imaging (MRI), and secondary outcomes include sustained changes in disease progression.
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