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

OXiGENE Announces Agreement With FDA On Special Protocol Assessment For A Phase 3 Trial Of ZYBRESTAT(R) In Anaplastic Thyroid Cancer

SOUTH SAN FRANCISCO, Calif., Sept. 17, 2012 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that it has come to agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for its Phase 3 clinical trial (FACT 2) of ZYBRESTAT for the treatment of anaplastic thyroid cancer (ATC). The FACT 2 study is designed as a randomized, placebo-controlled, double-blinded study of 300 subjects randomized 1:1 to receive carboplatin and paclitaxel plus fosbretabulin versus carboplatin and paclitaxel plus placebo. The primary endpoint of the study will be to compare the median overall survival between the two arms. 

Commented Peter J. Langecker, M.D., Ph.D., President and Chief Executive Officer: "We appreciate the FDA's granting of the SPA for the pivotal FACT 2 trial of ZYBRESTAT in patients with anaplastic thyroid cancer. ATC is a tough disease – tough for patients who are faced with dire prospects, tough for doctors who have very little to offer in terms of therapy to their patients, tough for the company trying to develop a novel treatment and even tough for regulators who see the need but who also have to see certain criteria met to be able to approve a drug. We want to thank the agency for their very thoughtful and constructive process.

"ATC is the indication for which we have the most compelling data, suggesting an overall survival benefit for patients who receive ZYBRESTAT along with carboplatin and paclitaxel chemotherapy and that is the reason for our continued pursuit of this indication. ATC is a very rare tumor from which most patients die within few months of initial diagnosis, and thus represents a significant unmet medical need. We are hopeful that the receipt of the SPA will strengthen our ability to obtain funding to conduct the FACT 2 study, either through financing or partnering. We believe that vascular disrupting agents can make a valuable contribution to anticancer therapeutic regimens, and we look forward to advancing our VDA programs not only in ATC, but also in ovarian cancer, carcinoid syndrome, myeloid leukemia and other potential indications."

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
AAPL $93.24 0.00%
FB $117.81 0.00%
GOOG $701.43 0.00%
TSLA $211.53 0.00%
YHOO $36.94 0.00%


Chart of I:DJI
DOW 17,660.71 +9.45 0.05%
S&P 500 2,050.63 -0.49 -0.02%
NASDAQ 4,717.0940 -8.5450 -0.18%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs