Opexa Receives Clinical Trial Approval from Health Canada for Novel T-Cell Therapy
THE WOODLANDS, Texas - (November 13, 2012) - Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced that Health Canada has approved the Company's Clinical Trial Application (CTA). The application was filed with the Biologics and Genetic Therapies Directorate. With this approval by the Canadian Health Authority, Opexa expects to expand its ongoing clinical trial in Secondary Progressive MS (SPMS) patients to include several sites in Canada. The Abili-T trial, a Phase 2b study of Tcelna in subjects with SPMS, is currently enrolling patients in the United States.
To date, over a half of the clinical sites have been initiated and approximately ten percent of subjects have been enrolled. Enthusiasm and support remains strong among the patients and the treatment sites. The trial is expected to enroll 180 patients in approximately 30 sites in the U.S. and Canada and conclude in 2015.
In addition, at the end of September, The United States Adopted Names Council (USANC) officially adopted Tcelna's non-proprietary name, imilecleucel-T. USANC is tri-sponsored by the American Medical Association, the United States Pharmacopeial Convention, and the American Pharmacists Association. USANC aims to standardize drug nomenclature by selecting informative and unique non-proprietary names for all pharmaceuticals marketed in the U.S. The name imilecleucel-T is derived from a set of regulations and guidelines set forth by USANC specific to cellular therapies. The non-proprietary name will be used in conjunction with the brand name, Tcelna, in publications and certain communication material appearing as "Tcelna (imilecleucel-T)".
"We are very pleased with the progress of the Abili-T SPMS clinical trial to date," stated Neil K. Warma, President and CEO of Opexa. "The clinical trial sites are being activated as planned and screening of patients for enrollment into the trial is on schedule due to the patients' enthusiasm to participate in the trial and the efficient cooperation among the sites, our clinical staff and the various vendors. SPMS represents a market in dire need of new, safe and effective therapies. Currently there is only one FDA-approved treatment in the U.S. and it carries a safety warning that significantly limits its use. With the approval of the regulatory package by the Canadian Health Authority, we have taken another key step in the progress of the Abili-T trial, as it enables us to access large clinical practices that should enhance patient enrollment. Additionally, USANC's acceptance of Tcelna's non-proprietary name supports our rebranding effort and enables us to have more flexibility in meeting submission criteria in certain publications. We are also continuing to focus on securing the necessary capital required to continue and complete the trial," added Mr. Warma.
About SPMS
SPMS is a progressive phase of MS which is characterized by a steady progression of clinical neurological damage with or without relapses. After ten years of disease characterized by relapse events and remitting disability (RRMS), approximately 50 percent of patients will have progressed to SPMS. In SPMS, relapses dissipate over time and subjects experience general progression and increasing disability. It is believed that the resulting neurological damage cannot be reversed.
About Tcelna
Tcelna (imilecleucel-T) is a personalized therapy that is specifically tailored to each patient's disease profile. Tcelna is manufactured using ImmPath™, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response. Opexa believes the potential combination of efficacy, superior safety, excellent tolerability and administration may position Tcelna as an MS treatment of choice as compared to existing therapeutics.
About Opexa
Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as MS. The Company's leading therapy, Tcelna™, is a personalized cellular immunotherapy treatment that is in late stage clinical development for 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 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," "hopes," "anticipates," "estimates," "may," "could," "intends," "exploring," "enable," "enhance," "evaluating," "progressing," "proceeding" 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 rights and preferences provided to the Series A Convertible Preferred Stock and investors in the convertible secured notes issued by the Company in July 2012 (including a secured interest in all of our assets), 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 development programs (including to undertake and complete any ongoing or further clinical studies for Tcelna) including in this regard our ability to satisfy various conditions required to access the financing potentially available under the purchase agreements with Lincoln Park (such as the minimum closing price for our common stock, the registration of the underlying shares of common stock under the Securities Act of 1933, as amended, and the requirement for an ongoing trading market for our stock), the success of our clinical trials, the efficacy of Tcelna for any particular indication, such as for 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 or the rights of third parties, 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.
Contacts:
Neil K. Warma
Opexa Therapeutics, Inc.
President & CEO
281-775-0600
nwarma@opexatherapeutics.com