This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Generex Announces Scheduling Of USFDA End-of-Phase II Meeting For The AE37 Breast Cancer Vaccine

WORCESTER, Mass. and TORONTO, June 7, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) announced today that an End-of-Phase II meeting has been scheduled with the United States Food and Drug Administration (FDA) in respect of the Phase II clinical trial of the AE37 breast cancer vaccine being undertaken by its wholly-owned subsidiary, Antigen Express, Inc.

The meeting has been scheduled for June 18, 2012 with FDA regulatory management staff in the Office of Cellular Tissues and Gene Therapies in the Center for Biologics Evaluation and Research.  Antigen Express has provided the FDA with a comprehensive and detailed package regarding the AE37 breast cancer vaccine, the on-going Phase II clinical trial, and the company's plans for a transition into a pivotal Phase III trial.

Antigen Express will solicit guidance from the FDA regarding the company's proposed structure of a pivotal Phase III trial.

In addition to representatives of Antigen Express, Dr. Samuel Jacobs, MD, Director, Medical Affairs, National Surgical Adjuvant Breast and Bowel Project (NSABP) and a member of the Antigen Express AE37 breast cancer Scientific Advisory Board (SAB), will attend the meeting to proffer his advice and assistance on behalf of Antigen Express.  The NSABP is a clinical trials cooperative group supported since its inception by the National Cancer Institute (NCI). It has a more than 50-year history of designing and conducting clinical trials that have changed the way breast cancer is treated, and, more recently, prevented.  The NSABP was the first to demonstrate that adjuvant therapy could alter the natural history of breast cancer.  Since its inception, the NSABP has enrolled more than 110,000 women and men in clinical trials in breast and colorectal cancer.  It has research sites at nearly 1000 major medical centers, university hospitals, large oncology practice groups, and health maintenance organizations in the United States, Canada, Puerto Rico, Australia, and Ireland.  At those sites and their satellites, more than 5000 physicians, nurses, and other medical professionals conduct NSABP treatment and prevention trials.

In addition to Dr. Jacobs, another member of the SAB, an oncologist specializing in comparative effectiveness studies of targeted therapies and biomarkers, mathematical and statistical prognostic and predictive models, and advanced methods of evidence synthesis in support of clinical practice guidelines, will attend the meeting.

1 of 2

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 17,863.70 -112.61 -0.63%
S&P 500 2,075.53 -10.71 -0.51%
NASDAQ 4,920.1210 -27.32 -0.55%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs