Opexa Therapeutics Announces Tcelna(TM) as New Brand Name for MS Therapy

THE WOODLANDS, Texas, May 21, 2012 (BUSINESS WIRE) — Opexa Therapeutics, Inc. OPXA +6.85% , a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company is rebranding its leading MS therapy with the new name Tcelna(TM). The product, previously known as Tovaxin(R), will now be known as Tcelna as the company positions itself towards the treatment of patients with Secondary Progressive MS (SPMS).

“Opexa has worked diligently in the optimization of its overall manufacturing process and clinical development program while concentrating its efforts in the SPMS indication. The rebranding of our lead product as Tcelna encompasses these advancements and our continued dedication to make a difference in the treatment of MS,” commented Neil K. Warma, President and Chief Executive Officer of Opexa.

The name Tcelna (pronounced Te-SELL-nuh) reflects the T-cell derivation of the product. Opexa has requested a registered trademark for the new brand name.

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 therapy, Tcelna(TM), a personalized cellular immunotherapy treatment, is in clinical development targeting both Secondary Progressive and Relapsing Remitting MS. Tcelna 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, Tcelna, 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, Tcelna, on reasonably satisfactory terms (if at all), our dependence (if partnered) on the resources and abilities of any partner for the further development of Tcelna, 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 Tcelna, the success of our clinical trials, the efficacy of Tcelna 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 Tcelna), 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 Investors:

Carney Noensie Burns McClellan 212-213-0006 cnoensie@burnsmc.com

Results in For Potential MS Therapies

  • In a two-year Phase III trial, the oral MS therapy BG-12 significantly reduced – by up to 51%-the average number of annual MS relapses.  More than 1,400 people with relapsing-remitting MS participated in the study.  BG-12 is thought to inhibit the immunce cells and molecules that are involved in MS attacks on the brain and spinal cord.  This study should help to define further the safety and promise of BG-12 as a potential therapy for relapsing MS.
  • The experimental intravenous MS therapy alemtuzumab significantly reduced relapse rates and the worsening of disability in a two-year Phase III study that compared alemtuzumab to Rebif.  The study, called CARE-MS II, involved 840 people with relapsing-remitting MS.  The FDA has fast-tracked alerntuzumab, which should speed up future review.
  • A study of 324 patients comparing the MS oral therapy teriflunomide with Rebif found no significant difference in the numbers of participants in each group who experienced events defined as treatment failure.  Teriflunomide is thought to prevent damage to the nervous system by immune cells.  A previous phase III trial was more successful and three others are ongoing.  The FDA is reviewing an application for marketing approval of teriflunomide.

To stay current on MS therapies in the pipeline for FDA approval, sign up for MS eNEWS at www.nationalMSsociety.org/signup

Source: Northern California MS Connection