- Tovaxin
Tovaxin is a novel anti-
T-cell therapeutic vaccine that parallels the concept ofautologous cancer vaccines . Instead of modifying cancerous cells, TovaxinTM consists of attenuated autoreactive T cells. Tovaxin is being developed byOpexa Therapeutics inHouston, Texas Method of Action
Tovaxin takes a patients own T-cells from a
blood sample drawn in the clinic. Attenuation of the patient's T-cells during the vaccine production process renders the cells non-replicating but viable and causes them to elicit animmune response when injectedsubcutaneously (under the skin) into the patient. This immune response is directed against T-cells within the patient that are self-reactive withmyelin . Myelin is the sheath that covers theneurons that are affected inMultiple Sclerosis . This immune response, directed against a specific subset of autoreactive T cells, greatly reduces the number of these autoreactive cells in MS patients.During the latest study treatment has consisted of four injections spaced four weeks apart followed by one injection at 24 weeks. Biannual booster shots will follow. Only minimal side effects have resulted from the use of the treatment, these consisting of mild injection site reactions, typically clearing within a day.
As any other disease modifying therapy, Tovaxin attacks the underlying cause of MS rather than just addressing its symptoms.
tatus of FDA Trials
In October 2005, the Company presented positive interim research findings of its Phase I/II
clinical trial s of Tovaxin at the 21st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the 10th Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) congress held inThessaloniki, Greece . The trial results indicated that the treatment appeared safe and well tolerated with no dose-limiting toxicities, and that Tovaxin depletes the myelin-peptide reactive T cells that may contribute to theMultiple Sclerosis (MS) disease processes.PharmaFrontiers , currently namedOpexa Therapeutics , announced in late2005 that theU.S. Food and Drug Administration 'sCenter for Biologics Evaluation and Research (FDA's CBER) had approved the protocol for its Phase IIbclinical trial of Tovaxin. PharmaFrontiers conducted Phase IIb with its clinical development partner,INC Research ,Raleigh, North Carolina .That multicenter, randomized,
double blind ,placebo -controlled Phase IIb clinical study was designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell therapy with clinically isolated syndrome (CIS) and early relapsing-remitting MS (RR-MS) patients. Additionally, the study of these patients will evaluate biomarkers of Tovaxin's efficacy and to evaluate the effect of Tovaxin onimmune deviation andepitope spreading.The clinical trial finished on March 2008 [Opexa Therapeutics Announces Completion Of Mid Study Descriptive Analysis On Phase IIb Trial Of Tovaxin [http://www.medicalnewstoday.com/articles/100415.php] ] . Now, all patients who completed the trial are eligible to participate in an optional one-year extension study, in which they will receive Tovaxin open-label. The open-label study is being planned under a different protocol that will be submitted to the
Food and Drug Administration (FDA).References
External links
* [http://www.ihavems.com A Personal Experience with Tovaxin]
* [http://news.bbc.co.uk/1/hi/health/4787430.stm BBC Article 3/8/06]
* [http://www.upi.com/HealthBusiness/view.php?StoryID=20060309-042811-3384r UPI Health Brief]
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