Phase I/II Data presented at the AAN

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Phase I/II Data presented at the AAN

Postby flipflopper » Tue Apr 15, 2008 2:53 pm

http://www.centredaily.com/business/tec ... 26680.html



Opexa Therapeutics Presents Tovaxin Phase I/II Data at the American Academy of Neurology 60th Annual Meeting


THE WOODLANDS, Texas — Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced that Brian Loftus, M.D., of Bellaire Neurology and the Principal Investigator of the Tovaxin Phase I/II studies, presented data titled "Autologous Attenuated T-Cell Vaccine (Tovaxin(R)) Dose Escalation in Multiple Sclerosis Relapse-Remitting and Secondary Progressive Patients Nonresponsive to Approved Immunomodulatory Therapies" at the American Academy of Neurology meeting today. The AAN meeting is taking place at the McCormick Place West Convention Center in Chicago, IL.

The objective of the Tovaxin Phase I/II dose escalation study was to assess the safety and effectiveness of T cell vaccine (Tovaxin(R)) in MS patients non-responsive to approved immunomodulatory therapies. The trial results indicate statistically significant improvements from baseline observed using the annualized relapse rate and myelin-reactive T-cell count effectiveness measurements.

"The positive therapeutic effects of safety, early effectiveness and tolerability observed in this study suggest that depletion of myelin-reactive T-cells using Tovaxin, a trivalent T-cell vaccine, may be an appropriate treatment strategy for patients with MS and warrants further study," said Dr. Loftus.

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 multiple sclerosis 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

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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.

Opexa Therapeutics, Inc. Lynne Hohlfeld, 281-719-3421 lhohlfeld@opexatherapeutics.com
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Postby av8rgirl » Thu Apr 24, 2008 10:36 am

Has anyone seen any information other than the abstract?

http://www.acceleratedcure.org:8080/node/3205

but NOTHING about Tovaxin. I guess it wasn't worth their time... :x
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Postby Hub » Fri Apr 25, 2008 12:50 am

av8rgirl wrote:Has anyone seen any information other than the abstract?

http://www.acceleratedcure.org:8080/node/3205

but NOTHING about Tovaxin. I guess it wasn't worth their time... :x


av8rgirl,

You should click on the link again. Art clarified that there was no session on Tovaxin -- there was only a poster.
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Postby Loobie » Fri Apr 25, 2008 3:54 am

A freakin' poster! I hope it was a hell of a poster. But then again they are having $$$$ issues and I don't know how much data they can release yet on the IIb. I guess I thought there'd be more.
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Postby JanethePain » Fri Apr 25, 2008 7:17 am

Loobie wrote:A freakin' poster! I hope it was a hell of a poster. But then again they are having $$$$ issues and I don't know how much data they can release yet on the IIb. I guess I thought there'd be more.


I've suspected that when they get the last of the year's data from Patient # 150 that they'll make some sort of "First Year's Results" info available to the general public--and especially to prospective buyers. Shouldn't that be about an August time-frame?

If there are any plans to kick off Phase III as an overlap, they'd have to publish some first year's results, don't you think, it order to get the ball ready to roll for it? :?
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Postby av8rgirl » Fri Apr 25, 2008 7:21 pm

I saw his post...I've seen the poster. I was really hoping that someone would have done some sort of commentary or something about what was there....something more than the abstract. Hasn't the embargo been lifted?

I was under the impression that there was going to be a paper presented...I guess I was misinformed. :?
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