Tcelna (formerly known as Tovaxin) is an anti-
T cell
T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...
vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...
being studied in
multiple sclerosis
Multiple sclerosis (MS) is an autoimmune disease resulting in damage to myelinthe insulating covers of nerve cellsin the brain and spinal cord. As a demyelinating disease, MS disrupts the nervous system's ability to Action potential, transmit ...
(MS).
As of 2016 it is in phase II trials.
History
The company announced in late 2005 that the
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
had approved the protocol for the Phase IIb clinical trial of Tcelna.
The multicenter, randomized,
double blind
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expec ...
,
placebo
A placebo ( ) can be roughly defined as a sham medical treatment. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures.
Placebos are used in randomized clinical trials ...
-controlled Phase IIb clinical study on 150 patients was designed to evaluate the efficacy, safety and tolerability of the therapy with clinically isolated syndrome (CIS) and early relapsing-remitting MS (RR-MS) patients.
The first phase of the trial finished in March 2008. All patients who completed the trial were to be eligible for an optional one-year extension study, OLTERMS, to receive Tcelna open-label without a placebo group; however, that program was terminated suddenly for lack of funding.
After several financial troubles, the trials were restarted in 2011
"Tcelna phase III announced" Opexatherapeutics
/ref> and Opexa rebranded the therapy, previous called Tovaxin, with the new name Tcelna.
References
{{reflist
External links
BBC Article 3/8/06UPI Health BriefOpexa Therapeutics Tcelna PageThe US clinical trial registry NCT01684761 Tcelna phase II trial for SPMS.
Vaccines