Further Enhancing Tovaxin Production Process in Support of Future Clinical Trials
THE WOODLANDS, Texas--(BUSINESS WIRE)-- 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 Blood Group Alliance, Inc. (BGA), a cooperative of community blood centers, to provide blood collection services to support Opexa’s clinical studies, including a planned Phase III study of Tovaxin in patients with Relapsing-Remitting MS.
This agreement will substantially enhance the overall process for the production of Tovaxin as the first step in the manufacturing process is obtaining a unit of whole blood from the patient. With BGA’s North American footprint extending throughout the United States and into Canada, patients in Opexa’s clinical trials will have access to a very broad network of treatment centers ensuring improved efficiency in blood collection. BGA has agreed to manage the collection of the blood and ship the units to Opexa’s facility for further manufacturing of the Tovaxin product. Opexa recently announced a similar agreement with the American Red Cross. In combination, these two groups provide Opexa with access to over 90% of the blood procurement centers in the United States. With these agreements, Opexa has now put into place a strong network of procurement locations nationwide which provide feasibility for commercialization as well as an excellent supply chain for Opexa’s future clinical studies.
"The feasibility of procurement for the clinical manufacture of Tovaxin has been solidified with the execution of these agreements,” commented Jaye Thompson, Ph.D., Senior Vice President, Clinical Development and Regulatory Affairs of Opexa. “We are pleased to be associated with BGA and their network of community blood centers. Our partnership will allow Opexa great flexibility to utilize investigational sites in almost any location for future Tovaxin studies. This unlimited access will be valuable for our patients and physicians. In addition, these contracts should result in a stable and reduced cost of goods in the manufacture of Tovaxin.”
Charles Mosher, President and CEO, Blood Group Alliance, commented, “We have purposefully been reaching out to provide services to the cell therapy industry since 2005. Our goal is to provide the industry and our cooperative members the opportunity to collaborate in a mutually beneficial way to support patient needs. BGA is pleased to support the planned Phase III clinical trial of Tovaxin, a novel therapy that may positively impact the lives of patients with a chronic disease that poses risk of debilitation. We look forward to working together during Opexa’s Phase III study and through commercialization.”
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 late stage 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 a Phase III clinical trial 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.
Blood Group Alliance was created in 2010 as a collaboration between Blood Centers of America, Inc (BCA) and GSABC Cooperative Association (GSABC) whose members together provide over half of the US blood supply. BGA focuses its services in five primary areas to support blood center operations which include the sale of recovered plasma, supply chain initiatives, vendor qualification, hospital GPO affiliation and cell therapy contracts. It has over 70 US blood center members.
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.
Opexa Therapeutics, Inc.
Neil K. Warma, 281-775-0600
President & CEO
KEYWORDS: United States North America Texas
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical General Health