Ziopharm designed PICASSO-3 with the assumption that STS patients treated with doxorubicin alone would yield a median PFS of 4.3 months, or equal to the results seen in PICASSO. The study was powered so that a median PFS benefit of three months or more for patients treated with palifosfamide-doxorubcin (median PFS of 7 months-plus) will produce statistically significant results. Expressed another way, Ziopharm is aiming for a 40% reduction in the relative risk of tumor progression, which if achieved, may also produce a survival benefit.
I believe the addition of palifosfamide to doxorubicin is likely to demonstrate some improvement over doxorubicin alone in STS patients in PICASSO-3. I'm less confident about results replicating what was seen in PICASSO, meaning the study could fail to achieve the primary endpoint with statistical significance.
Given the lack of additional treatment options for STS patients, Ziopharm is likely to seek U.S. approval of palifosfamide even if PICASSO-3 results only show a trend favoring the drug. An absolute benefit in PFS of at least two months coupled with no additional toxicity might be viewed favorably by an FDA advisory panel and could lead to FDA approval.
Chaudhry has no position in Ziopharm.Follow Aafia Chaudjry on Twitter.
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 + 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