More on Tovaxin and Phase IIb Clinical Trials

I’m just going to take it straight from Opexa’s press release that I found today on MarketWatch about the “upcoming Phase IIb clinical trial using Opexa’s T-cell therapy in patients with Secondary Progressive Multiple Sclerosis (SPMS).”

We’ve written about Opexa before because they seem to understand that NOT killing the patient is the best way to try and treat Multiple Sclerosis.

Everything below is taken directly from MarketWatch

PRESS RELEASE

April 19, 2012, 8:30 a.m. EDT

Opexa to Hold Preliminary Investigator’s Meeting for MS Trial at American Academy of Neurology Annual Meeting

Dr. Mark Freedman and other Members of Opexa’s SAB to introduce SPMS clinical trial to prospective trial physicians

THE WOODLANDS, Texas, Apr 19, 2012 (BUSINESS WIRE) — Opexa Therapeutics, Inc. OPXA -0.24% , a biotechnology company developing Tovaxin(R), a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company will be holding a preliminary meeting with prospective clinical trial investigators at the 64th Annual American Academy of Neurology (AAN) Meeting in New Orleans on April 24, 2012. The purpose of this meeting will be to discuss the upcoming Phase IIb clinical trial using Opexa’s T-cell therapy in patients with Secondary Progressive Multiple Sclerosis (SPMS).

“We are honored to introduce our next clinical trial to a group of invited neurologists at this year’s AAN meeting in New Orleans,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “The meeting will be an opportunity to discuss with select clinicians and their study coordinators potential participation in the SPMS clinical trial as well as present the final protocol for the trial including the design, structure and patient selection criteria. This is an exciting time for Opexa, neurologists and SPMS patients as this study will provide an innovative opportunity for treatment in an area where currently there are very few treatment options. The annual AAN meeting is an excellent forum for the MS community to discuss and present new therapies that could have an important impact on the treatment of MS. We are pleased that Tovaxin is generating a great deal of enthusiasm among physicians, key opinion leaders and patients in the lead up to this meeting and are equally pleased to be advancing our clinical plans for Tovaxin.”

Mark Freedman, M.D., director of the Multiple Sclerosis Research Unit at the Ottawa Hospital and member of Opexa’s Scientific Advisory Board, commented, “I am pleased to contribute my expertise to Opexa with their design and planning of this Phase IIb study. Opexa is now in the process of selecting clinical trial investigators and finalizing the remaining steps in order to conduct a study of optimal quality. I am pleased to facilitate the introduction of the Phase IIb study to prospective clinical trial investigators at this year’s AAN meeting. Patients with SPMS have few treatment options and Tovaxin’s safety profile certainly justifies investigation of this therapy in the challenging SPMS patient population.”

The proposed Phase IIb clinical trial will be a randomized, double-blind, placebo-controlled study of Opexa’s T-cell therapy in SPMS patients with evidence of disease progression without associated relapses. The study, to be initiated once the necessary resources are secured, is expected to treat approximately 180 patients in up to 30 sites in the United States and Canada with annual courses of treatment for two years.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS). The Company’s leading T-cell therapy, a personalized cellular immunotherapy treatment, is in clinical development targeting both Secondary Progressive and Relapsing Remitting MS. Opexa’s T-cell therapy is derived from T-cells isolated from peripheral blood, expanded ex vivo and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time.

For more information, visit the Company’s website at http://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 which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “expects,” “believes,” “anticipates,” “estimates,” “may,” “could,” “intends,” and similar expressions are intended to identify forward-looking statements. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding the development of the Company’s product candidate, Tovaxin, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our capital position, the ability of the Company to enter into and benefit from a partnering arrangement for the Company’s product candidate, Tovaxin, on reasonably satisfactory terms (if at all), our dependence (if partnered) on the resources and abilities of any partner for the further development of Tovaxin, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of developing a marketable product, our ability to raise additional capital to continue our treatment development programs and to undertake and complete any further clinical studies for Tovaxin, the success of our clinical trials, the efficacy of Tovaxin for any particular indication, such as Relapsing Remitting MS or Secondary Progressive MS, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights (including for Tovaxin), the risk of litigation regarding our intellectual property rights, the success of third party development and commercialization efforts with respect to products covered by intellectual property rights that the Company may license or transfer, our limited manufacturing capabilities, our dependence on third-party manufacturers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date made. We assume no obligation or undertaking to update any forward-looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in our reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2011.

SOURCE: Opexa Therapeutics, Inc.

        Neil K. Warma
        Opexa Therapeutics, Inc.
        President & CEO
        281-775-0600
        nwarma@opexatherapeutics.com
        or
        Institutional Investors:
        Carney Noensie
        Burns McClellan
        212-213-0006
        cnoensie@burnsmc.com

Copyright Business Wire 2012

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