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

RedHill Biopharma Reports Successful RHB-102 Bioavailability Clinical Trial And Planned Submission Of European Marketing Application In Q3/2014

  • RedHill received positive results from a comparative bioavailability clinical trial which included 20 healthy volunteers
  • In light of the positive results, and subject to regulatory requirements, the Company plans to submit, during the third quarter of this year, a European marketing application for RHB-102 for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting in cancer patients
  • RHB-102 is a proprietary, once-daily, extended release oral pill formulation of the anti-emetic oncology support drug ondansetron
  • RedHill is also pursuing a new undisclosed indication for RHB-102, which may significantly expand its potential market, with a Phase III study planned to commence in the U.S. later this year

TEL-AVIV, Israel, April 30, 2014 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, today reported positive results from a comparative bioavailability study with RHB-102, a proprietary, extended-release, once-daily oral pill formulation of the anti-emetic oncology support drug ondansetron for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting ("CINV" and "RINV" respectively).

The results of the study are subject to final quality assurance and an independent study report by the Canadian clinical research organization ("CRO") that conducted the study. The final independent report from the CRO is expected in the coming weeks.

The two-arm crossover comparative bioavailability study conducted in Canada followed a positive European scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency ("MHRA"), announced on April 7, 2014. The study, which included 20 healthy volunteers, was designed to support the planned European Marketing Authorization Application ("MAA") for RHB-102 and to explore the relative bioavailability between RHB-102 and GlaxoSmithKline's European reference drug. The results of the study demonstrated that the exposure provided by RHB-102 supports its effectiveness and safety.

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
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
AAPL $92.72 -0.56%
FB $119.49 1.43%
GOOG $711.12 1.38%
TSLA $214.93 1.61%
YHOO $37.23 0.79%


Chart of I:DJI
DOW 17,740.63 +79.92 0.45%
S&P 500 2,057.14 +6.51 0.32%
NASDAQ 4,736.1550 +19.0610 0.40%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs