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

Threshold Pharma Seeks to Erase Doubts About Pancreatic Cancer Drug

VIENNA ( TheStreet) -- Threshold Pharmaceuticals (THLD - Get Report) presented new data Saturday showing how pancreatic cancer patients who "crossed over" in a mid-stage clinical trial of TH-302 may have hampered the drug's ability to demonstrate a stronger improvement on overall survival.

When these crossover patients were excluded from the analysis of the phase II study, the survival benefit attributable to TH-302 improved.

The new analysis was an effort by Threshold to alleviate investor concerns about the future of TH-302. The company's stock price has fallen by 20% over the past two weeks because of worries that TH-302 would not help patients live longer in a larger, phase III trial scheduled to start soon.

Threshold shares closed Friday at $7.24

The phase II study enrolled 214 pancreatic cancer patients and randomized them to treatment with TH-302/gemcitabine or gemcitabine alone. As presented earlier this year, treatment with TH-302/gemcitabine led to a two-month improvement in progression-free survival of 5.6 months compared to 3.6 months for gemcitabine alone. The benefit in PFS was statistically significant, although there were some imbalances in patients' baseline criteria that favored TH-302 and may have skewed results.

An analysis of overall survival from the TH-302 study was less favorable. TH-302/gemcitabine reduced the relative risk of death by 4.5% compared to gemcitabine alone -- a small survival benefit that was not statistically significant. This survival analysis was made public two weeks and was responsible for the selloff in Threshold shares.

Threshold attributed the modest survival benefit, in part, to patients in the gemcitabine control arm of the study that "crossed over" and began treatment with TH-302 after their tumors began growing again. This made it more difficult for the study to measure the true survival benefit of TH-302 since patients in both arms of the study were treated with the drug.

To add weight to its argument, Threshold on Saturday presented new data from the study that excluded the 38% of patients in the control arm who crossed over to treatment with TH-302. The new data were presented in conjunction with the presentation of the TH-302 phase II data at the European Society for Medical Oncology [ESMO] annual meeting.

Without crossover patients, TH-302 plus gemcitabine reduced the relative risk of death by 24-25% over gemcitabine alone. That's an improvement over the 4.5% risk reduction for death when the crossover patients were factored into the analysis. [Two doses of TH-302 were studied.]
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
CELG $103.41 0.00%
THLD $0.44 0.00%
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 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