Monday, August 19, 2013
GTx muscle drug fails late-stage trials, shares plunge
Mon Aug 19, 2013 9:22am EDT
(Reuters) - GTx Inc said its experimental drug to treat muscle wasting in cancer patients was not effective in improving body mass in late-stage trials, sending its shares plunging 67 percent.
The drug, enobosarm, the most advanced in GTX's pipeline, also failed to improve physical function in patients, measured by improvement in their ability to climb stairs.
A 3-mg dose of the drug was tested on about 325 patients with non-small cell lung cancer - the most common form of lung cancer.
There is no approved cure for cancer-induced muscle wasting, which results in decreased physical function, fatigue and weight loss.
GTx Chief Executive Mitchell Steiner said he believes the drug will provide clinical benefit potentially increasing survival in patients with non-small cell lung cancer.
Memphis, Tennessee-based GTx said it plans discuss the path forward for enobosarm with the U.S. Food and Drug Administration and European regulatory authorities.
Enobosarm was granted fast-track status by the U.S. Food and Drug Administration in January. A fast-track designation expedites regulatory review of drugs that aim to treat serious diseases and fill unmet medical needs.
The company has four other experimental drugs in its pipeline. One of them, Capesaris, to treat advanced prostate cancer, is currently in mid-stage studies.
GTx shares fell to $1.37 in premarket trade on Monday. They closed at $4.15 on Friday on the Nasdaq.
(Reporting by Pallavi Ail in Bangalore; Editing by Saumyadeb Chakrabarty)
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Source : http://feeds.reuters.com/~r/reuters/healthNews/~3/iM2bRf9nrkk/story01.htm