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

Gauging Ziopharm's Chances for Positive Sarcoma Drug Trial Results

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.
Aafia Chaudhry M.D. is a founding partner at Noesis LLC, an investment-management firm focused on the pharmaceutical and biotechnology sectors. She originally trained in general surgery prior to transitioning into the health-care industry. Aafia has been an active life-sciences investor for the past nine years and is an expert in pharmaceutical life-cycle management strategy. She was formerly president of 81qd, a strategic data-analytics consultancy, and most recently served as vice president of strategic market planning at WebMD Health Corp.
3 of 3

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
ZIOP $7.86 0.00%
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs