This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Opexa Receives Clinical Trial Approval From Health Canada For Novel T-Cell Therapy

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.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 17,846.56 +126.64 0.71%
S&P 500 2,096.47 +16.06 0.77%
NASDAQ 5,145.8940 +37.2280 0.73%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs