Opexa Initiates Discussions with Health Canada in Pre-CTA Meeting
Health Canada Provides Guidance on Clinical Trial Protocol for Opexa’s Planned Phase III Clinical Trial
THE WOODLANDS, Texas--(June 2, 2011)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company met this week with Health Canada’s Biologics and Genetics Therapies Directorate (BGTD), in a pre-Clinical Trial Application (pre-CTA) meeting. A complete CTA must be filed with and approved by BGTD prior to the initiation of a clinical trial in Canada.
The pre-CTA consultation meeting provided an opportunity for Opexa to review the status of the Tovaxin development with the Canadian Health Authority (the equivalent to the FDA in the U.S.). Opexa presented data related to the safety and efficacy of Tovaxin and reviewed the manufacturing process and clinical trial protocol for the planned Phase III program. Health Canada provided valuable guidance on the planned clinical trial further enhancing Opexa’s goal of a successful outcome.
"Canada has one of the highest prevalence of MS in the world and as such there has evolved a tremendous expertise in researching and managing the disease. We would welcome Opexa to conduct their pivotal studies in Canada, giving our patients an opportunity to experience a promising new and innovative therapy and allow our researchers to gain experience in this exciting area of treatment" commented Mark S. Freedman, MSc MD FAAN FRCPC, Director of Multiple Sclerosis Research Unit, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario Canada.
Neil Warma, President and CEO of Opexa Therapeutics, commented, "Health Canada acknowledged the novel approach of our T-cell technology for the treatment of MS and commented on the encouraging safety and efficacy data collected to date. This discussion, similar to those we held with the U.S. FDA several months ago, paves the way for us to potentially use Canadian sites in any future trial with Tovaxin. We envision using both U.S. and Canadian trial sites in the planned Phase III program. Canada has some of the most respected MS opinion leaders in the world, a couple of which are on our Advisory Board, and several of the leading treatment centers for MS. Our next step will be to prepare and submit the full dossier on Tovaxin as part of the CTA, which we envision completing over the next few months. We will need a positive review and approval from Health Canada prior to initiating any clinical study, but this meeting was a key step in the process and allowed us to gain valuable guidance from the Agency in fine-tuning our development plan."
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 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.