Additional information concerning these factors is contained in our filings with the SEC today, which are available on our investor section of our website.
While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so even if our assumptions change.
You should not rely on these forward-looking statements as representing our assumptions as of any date subsequent to today. We issued a press release this morning and on today’s call, Ron will discuss the partial clinical hold based on IDX 184, and then we will open up the call up for Q&A. I'll now turn the call over to Ron.
Ron RenaudThanks Daniella. We were verbally notified by the FDA late yesterday afternoon that our clinical candidate IDX184 has been placed on partial clinical hold. We believe this is a result of the recent occurrence of a serious cardiac-related adverse event with Bristol-Myers BMS094 which is that company’s nucleotide pro-drug for the treatment of HCV.The FDA has expressed an interest in further reviewing the safety of IDX184 and therefore it has placed IDX184 on partial clinical hold.In previous clinical trials as well as the ongoing Phase IIb clinical trial of IDX184 dosed in combination with pegylated interferon and ribavirin, there has been no evidence to date of cardiotoxicity in patients dosed with IDX184 and pegylated interferon and ribavirin, beyond that seeing with pegylated interferon and ribavirin alone.I should also add that there are no -- there are currently no patients receiving IDX184 worldwide. We believe and we assert that there are significant differences between IDX184 and BMS094, including an entirely different pro-drug approach.In our view there at least three components of BMS094 and its metabolites that are not present in IDX184 and which could have contributed to the reported toxicity of BMS094.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- 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 + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV