Opexa Therapeutics Inc. : Opexa Receives Clinical Trial Approval From Health Canada for Novel T-Cell Therapy

11/13/2012| 08:50am US/Eastern

Abili-T Clinical Trial Targeting Expansion to Canada; Non-proprietary Name Granted by USANC

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.