GTx CEO Blames FDA for Bone Drug Rejection: BioBuzz

MEMPHIS, Tenn. (TheStreet) -- GTx(GTXI Quote) CEO Mitch Steiner blasted the Food and Drug Administration on a conference call Monday morning after regulators refused to approve the company's bone drug acapodene.

"They moved the goalposts on us," said Steiner, referring to the FDA's complete response letter, which he says asks GTx to conduct one, perhaps two, new clinical studies in order to get acapodene approved.

Steiner said that the FDA previously had agreed to base its approval review on a single study showing acapodene could lower the risk of bone fracture in men undergoing hormonal treatment for prostate cancer.

Monday, however, the FDA rejected acapodene, asking GTx for additional clinical data on the drug's efficacy and safety as well as proof that treatment with the drug does not cause prostate tumors to grow or shorten a patient's overall survival.

Steiner called the first FDA request a "surprise" and the second request -- the one seeking data disproving acapodene's link to tumor progression -- "an even greater surprise."

He said that these FDA requirements were added on at the last minute of acapodene's review and never came up in conversations between the company and the agency.

Acapodene has been linked to significant side effects and risk to patients, including blood clots and prolongation of the Qt interval, a measure of the heart's electrical cycle. Yet, Steiner, on his conference call, says neither safety issue was brought up in the FDA's complete response letter.