Tclena (Tovaxin)

By jefff Added at September 6, 2015 Views 1,496 Reviews 1

Tclena is a personalized T-cell immunotherapy in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive Multiple Sclerosis. Tcelna is specifically tailored to each patient’s immune response profile to myelin and is designed to reduce the number and/or functional activity of specific subsets of myelin-reactive T-cells (MRTC) known to attack myelin.

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jefff September 6, 2015 at 1:31 am   

Tcelna possesses a unique mechanism of action that combats the demyelination of the nerve fibers in the central nervous system, the underlying cause of MS. There have been five clinical trials thus far that have been completed with Tcelna in 356 patients, many with multiple years of treatment. Tcelna may possess a number of advantages compared to other MS therapies currently available or in development, including: A personalized autologous immunotherapy that is manufactured for every individual patient. A level of efficacy in the first few waves of the clinical trials conducted to date demonstrate that Tcelna may result in a reduction in the Annualized Relapse Rate (ARR) for patients with MS, slowing of disease progression and evidence of an improvement in disability in a number of MS patients, which could suggest a neuro-protective benefit. It is believed to have a level of safety and tolerability whereby this treatment selectively targets and regulates the pathogenic T-cell population and is not a general immune suppressant. Currently, improved compliance therapies are administered monthly and, in some cases, daily…but the treatment regimen for Tcelna consists of only five subcutaneous injections per year!


Patients with Secondary Progressive MS (SPMS) represent approximately 50% of the total MS population, yet treatment options remain very limited. Currently, there is only one product specifically approved for patients with SPMS, and that product carries a black box warning due to severe cardio toxicity. In an effort to meet this significant unmet medical need, Opexa is currently conducting a Phase IIb clinical trial of Tcelna in SPMS patients, but warn still that this is ONLY a trial!