THE WOODLANDS, Texas--()--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company has executed an agreement with the American Red Cross to provide blood procurement services to support Opexa’s upcoming Phase III study of Tovaxin in patients with Relapsing-Remitting MS.
“The past 12 months have been transformational for the Company as we prepare to bring Tovaxin into Phase III clinical studies”
Tovaxin is produced from an autologous whole blood procurement that is collected at a licensed collection facility. American Red Cross is the largest single supplier of blood and blood products in the United States, collecting and processing more than 40 percent of the blood supply and distributing it to some 3,000 hospitals and transfusion centers nationwide. Access to the American Red Cross centers across the U.S. will provide Opexa with a strong network of procurement locations nationwide, enhancing the efficiency of Opexa’s Phase III pivotal study and improving patient convenience.
"The past 12 months have been transformational for the Company as we prepare to bring Tovaxin into Phase III clinical studies,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “A partnership of this nature with the American Red Cross will enhance the patient and physician experience in the planned Phase III clinical trial substantially by offering the highest quality procurement services, both in terms of safety and convenience. Furthermore, this relationship solidifies Opexa’s supply chain for a seamless procurement of patient blood and will contribute significantly to an overall reduction in costs of goods.”
Rich Feliciano, Vice President, Business Development and Integration for the American Red Cross Biomedical Services, commented, “The Red Cross is pleased to support the upcoming planned Phase III clinical trial of Tovaxin. MS is the most common neurological cause of disability in young adults. We believe that the field of cellular therapy has great potential to have a positive impact on the lives of patients, and we look forward to working together during Opexa’s Phase III study and potentially into the future. With our extensive network of fixed blood collection sites, the Red Cross can provide blood collections in support of Tovaxin’s clinical trial across the United States.”
Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The Company’s leading therapy, Tovaxin®, is a personalized cellular immunotherapy treatment that is in clinical development for MS. Tovaxin 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.
Opexa is preparing for Phase III clinical trials with Tovaxin following the completion of a Phase IIb clinical study in 150 patients with MS. Data from this clinical study show evidence that relapsing-remitting MS patients treated with Tovaxin saw overall clinical and disability benefits over the placebo group, including a clinically relevant decrease in the Annualized Relapse Rate (ARR), and improvement in disability score (EDSS), as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.
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 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, 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 transferred by the Company, 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, 2010.