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

Progenics Pharmaceuticals Relaunching Registrational Trial Of Azedra To Treat Pheochromocytomas

TARRYTOWN, N.Y., Nov. 25, 2013 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that it is resuming a phase 2b clinical study of safety and efficacy of a novel targeted radiotherapy, Azedra , in patients suffering from pheochromocytomas. Existing options for these rare endocrine tumors that form in the adrenal glands can fail to result in effective disease treatment.

Daniel Pryma, M.D., Assistant Professor of Radiology and Nuclear Medicine/Molecular Imaging Modality Chief of the Department of Radiology at the University of Pennsylvania Perelman School of Medicine, and lead investigator in the trial, said, "I have seen in my own research evidence that Azedra is a promising agent for the treatment of metastatic pheochromocytoma and paraganglioma – two orphan oncology indications with tragically unmet needs. There currently are no medications approved specifically to treat pheochromocytomas and paragangliomas."

Azedra originally was developed by Progenics' Molecular Insight Pharmaceuticals (MIP) subsidiary, which commenced the phase 2b study under a 2009 Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA). The compound also has Orphan Drug and Fast Track designations, which are intended to get important new therapies to patients sooner by expediting the review of drugs for serious conditions filling unmet medical needs. In late 2010 MIP suspended the trial, with enrollment two-thirds complete, to seek additional funding. Progenics, which acquired MIP in early 2013, plans for patient recruitment to continue after making drug supply manufacturing arrangements for the trial. 

Following a successful completion of this phase 2b study, Progenics intends to submit a New Drug Application (NDA) and request priority review to receive FDA action on the application within six months instead of the standard ten.

Hagop Youssoufian, M.Sc., M.D., Executive Vice President of Research and Development for Progenics, said, "Azedra has the potential to be the first approved treatment for pheochromocytomas. Our team is energized by this opportunity to potentially bring a treatment option with improved dosing, safety and efficacy to patients suffering with these devastating conditions."

1 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
AAPL $93.99 0.00%
FB $102.01 0.00%
GOOG $682.40 0.00%
TSLA $151.04 0.00%
YHOO $27.04 0.00%


Chart of I:DJI
DOW 15,973.84 +313.66 2.00%
S&P 500 1,864.78 +35.70 1.95%
NASDAQ 4,337.5120 +70.6750 1.66%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs