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Opexa Therapeutics Presents Myelin Reactive T-Cell Research at the International Society of Cell Therapy Annual Meeting

Posted on: Thursday, 22 May 2008, 09:01 CDT

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced a recent poster presentation at the 2008 Annual Meeting of the International Society of Cell Therapy held in Miami May 17th-20th. The poster, titled "Persistence of Myelin Reactive T-cells in Relapsing-Remitting Multiple Sclerosis Patients Receiving Immunomodulatory Treatment" was presented on Monday, May 19th.

Multiple Sclerosis (MS) patients frequently have circulating myelin reactive T-cells (MRTC) as detected by an epitope analysis screening assay (EAA). The EAA measures proliferative responses of patient peripheral T-cells upon exposure to peptides of myelin proteins. Patient-specific T-cell lines for Tovaxin(R) vaccine formulation are then generated using synthetic peptides across myelin basic protein, proteolipid protein, and myelin oligodendrocyte glycoprotein.

As a prelude to the Tovaxin for Early Relapsing Multiple Sclerosis (TERMS) Phase IIb clinical study, 30 relapsing-remitting MS (RRMS) patients on various immunomodulatory therapies were evaluated for MRTC using the EAA. At the time of blood draw 11 subjects were being treated with glatiramer acetate, 11 were being administered beta-interferon, and 8 patients were not taking immunomodulary medication. Of the 30 subjects screened in this cohort, MRTC were detectible in 19 patients (63.3%). When stratified by therapy, 8/11 glatiramer acetate users (72.7%), 7/11 beta-interferon users (63.6%), and 4/8 patients not on MS therapy (50.0%) were positive for MRTC activity. Reactivity among subjects varied from 1 -12 peptides and were present across all three major myelin proteins. The study was conducted at a single site by Edward J. Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas.

"This study indicates that certain immunomodulatory agents used in MS treatment may not completely suppress circulating MRTC and that the EAA can be used to assess patient-specific MRTC profiles," said Dr. Fox.

About T-cell Vaccination

For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in MS patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in some patients treated in earlier clinical studies.

About Opexa Therapeutics

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product, Tovaxin, a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, obtain FDA approval for its therapeutic products, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Business Wire

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