This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Cleveland BioLabs Receives FDA Meeting Minutes And Advice Letter On Clinical Protocol For Development Of Entolimod(TM) (CBLB502) As Radiation Countermeasure

Stocks in this article: CBLI

BUFFALO, N.Y., Oct. 1, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced the receipt of the End-of-Phase II meeting minutes (the "Minutes") and an Advice Letter providing further clarification on the remaining clinical study protocols for the development of Entolimodâ„¢ (CBLB502) as a radiation countermeasure from the U.S. Food and Drug Administration (the "FDA").

The Minutes reiterated the FDA's commitment to moving the Entolimodâ„¢ program forward and summarized the Agency's responses and requests regarding several aspects of the Company's proposed plan for dose conversion, as discussed during the meeting and in related correspondence.

The Advice Letter provided specific guidance on the structure of the remaining clinical studies, including two primary study outcomes: generation of additional biomarker information for dose conversion as an initial study focus and then subsequent generation of extended safety data using the projected efficacious dose defined by the initial dose conversion study. The letter also provided specific recommendations on several technical aspects of the Company's proposed clinical protocol that remain in active and ongoing discussion.  

Yakov Kogan, Ph.D, MBA, Chief Executive Officer of Cleveland BioLabs, stated, "This correspondence represents a significant step forward in delineating the path forward for Entolimodâ„¢ and we continue to be pleased by our interactions with the FDA. We believe that the receipt of the Minutes and feedback on our clinical program, along with our previously announced agreements on the pivotal animal program enable us to continue funding discussions with our government agency partners."

The Company previously announced the receipt of an Advice Letter from the FDA indicating agreement with the design of the proposed pivotal animal efficacy studies and accepting the Company's recently concluded Good Laboratory Practice non-human primate study as part of the pivotal program.

Entolimodâ„¢ is a therapeutic drug currently in development under the FDA's Animal Rule to reduce the risk of death after total body irradiation. The Animal Rule provides a mechanism for marketing approval when human efficacy studies are not ethical or feasible. Development under the Animal Rule includes efficacy studies in animal models and human safety studies, as well as studies to support the conversion of the effective dose in animals to an effective dose in humans.

1 of 2

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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!


DOW 17,356.87 +288.00 1.69%
S&P 500 2,012.89 +40.15 2.04%
NASDAQ 4,644.3120 +96.4780 2.12%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

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