Osiris Therapeutics Takes a Bumpy Ride
In addition, 42% of the patients in the study had GVHD involving the skin only, which again, is easier to treat compared with GVHD affecting the GI tract or internal organs.
Osiris used a liberal definition of response to measure Prochymal's efficacy. In the study, a patient was measured for response on day 28 after treatment. Osiris says the complete response rate at that time point was 74%, double the historical rate.
But the study Osiris cites to make that comparison, published in 2002, defined complete response as total clinical resolution of GVHD at day 28, maintained for another 28 days without requiring any additional treatment.
There were nine patients in the Osiris study who required additional treatment after Prochymal to eliminate their GVHD, including four patients who Osiris deemed complete responders. These patients would not have counted as responders had Osiris used a stricter and more typical definition of efficacy.Mills defended the design and conduct of the Prochymal study. "We used an incredible [efficacy] standard for GVHD. The fact that we had 74% of patients with a complete response at day 28 is remarkable," he says. And he says the study design did not allow patients to be retreated with Prochymal, which explains why some patients required other, additional treatments even after they were deemed responders. "We have re-treatment data with Prochymal if GVHD returns, and it works very well, but not in this trial," he says.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $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
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV