This Day On The Street
Continue to site
ADVERTISEMENT
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 Initiates Discussions With Health Canada In Pre-CTA Meeting

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.”

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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 17,751.39 +121.12 0.69%
S&P 500 2,108.57 +15.32 0.73%
NASDAQ 5,111.7330 +22.5270 0.44%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs