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 MRTCs are raised against selected peptides from three myelin proteins (myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG), and proteolipid protein (PLP)).

The company manufactures Tcelna using its proprietary ImmPath technology. Opexa describes three main stages in this method of creating a T-cell immunotherapy. First, “procurement” involves collecting the patient’s blood.The “processing” stage encompasses the isolation of peripheral blood mononuclear cells (mainly the immune cells, or lymphocytes, which include T cells) and the generation of an autologous pool of MRTCs. The final stage is “treatment”, where the expanded, irradiated T-cells are reintroduced back to the patient. The attenuated T-cells (that are unable replicate in the body) 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. This did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. Tcelna did show a favorable safety and tolerability profile, Opexa Therapeutics announced in October 2016. “We would like to express our sincere thanks to the patients in the Abili-T trial, as well as to the principal investigators and study coordinators, for their contributions to the study”, said Neil K. Warma, President and Chief Executive Officer of Opexa.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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  1. Sharon L McLeod says:

    Diagnosed 2008 RRMS,exactly eight years later I am bedridden! I can’t afford help so I sit ten hours in a soiled diaper until my husband comes home! Please hurry with this medicine!

    • Sheryl says:

      God bless you, Sharon! I have lived with MS since my teens. Now 49. HORRIFIC neuropathic pain in my feet. SPMS for several years now caused me the loss of my nursing career, which led to my husband leaving me. MS has taken control of my life. Pain has left me with no quality of life. I can’t go one much longer.
      PLEASE get drugs for SPMS to the market NOW!

    • Monica says:

      I’m diagnosed 2008 also Spms now – bedridden no hope
      Tried stem cell DIDNT work got worse
      Just read Tcelna still not FDA approved and probably never will be. Last study results were not good

  2. Shawn McQuaige says:

    Look, I was in the clinical trial for tcelna in 2013 and 2014. I have done a 180 degree turn around. It took a full year after my last injection. When can we get this medicine. I have friends who need it. They even said if you are still conducting trials, they wanna sign up. PLEASE HELP

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