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

Bavarian Nordic Agrees On Interim Analysis With The FDA And Provides An Update On Its PROSPECT Phase 3 Trial

KVISTGAARD, Denmark, April 8, 2013 (GLOBE NEWSWIRE) -- Bavarian Nordic A/S (OMX: BAVA) today announced that the Company plans to conduct an interim analysis of the on-going PROSPECT Phase 3 trial of PROSTVAC(r) in prostate cancer patients with metastatic disease. The updated statistical analysis plan for the trial, which was recently accepted by the FDA, now includes pre-specified interim analyses of data that will be performed to evaluate whether the trial should continue as planned or potentially be stopped early for efficacy. In such case, a Biologics License Application may be filed at an earlier stage, potentially shortening the overall development time.

Enrollment in the trial is currently ongoing at almost 100 sites in 10 countries, and continues to expand into new countries and sites. As previously communicated, the initiation of new sites has been delayed due to a lengthier and more arduous regulatory process than anticipated in certain countries. Bavarian Nordic has responded to this delay by implementing a number of measures, aimed at completing enrollment within approximately one year.

Dr. James Breitmeyer, who was recently appointed President of BN Immunotherapeutics, Inc. said, "Enrollment in the PROSPECT study has been my first priority since I joined the company in February. Several enhancements to study conduct have been made to catch up on enrollment. Specifically, we have refocused our efforts towards high-performing clinical trial sites, an awareness program has been implemented, and we have hired additional internal and external resources to allow for a closer dialogue with the increasing number of clinical trial sites."

Two abstracts have been accepted for the American Society of Clinical Oncology (ASCO) Annual Meeting on May 31-June 4, 2013 in Chicago, Illinois, covering clinical safety data for PROSTVAC(r), and the rationale for and design of two new studies of PROSTVAC(r) given in combination with enzalutamide. In connection with the conference, Bavarian Nordic will also be hosting a PROSTVAC(r) update and reception. Further information will follow shortly.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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!

Markets

DOW 17,191.37 -195.84 -1.13%
S&P 500 2,002.16 -27.39 -1.35%
NASDAQ 4,637.9940 -43.5030 -0.93%

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