GTx Initiates Phase I Prostate Cancer Trial

Published: 07-Jul-2009

To establish proof of the ability of GTx-758 to reduce testosterone

GTx has initiated Phase I multiple ascending dose clinical trial evaluating GTx-758, an oral LH inhibitor for first line treatment of advanced prostate cancer. A Phase I single ascending dose clinical trial in 96 subjects was successfully completed in June.

In Phase I single ascending dose clinical trial, GTx-758 was well tolerated. GTx-758 demonstrated a pharmacokinetic profile compatible with once daily oral dosing and systemic exposures increasing with dose.

The ongoing Phase I multiple ascending dose clinical trial is an open label, single center study of five dose groups of GTx-758, with ten healthy male subjects per group each receiving doses for 10 days. The study will evaluate the safety, tolerability and pharmacokinetic profile of GTx-758.

In addition, testosterone and other hormones will be measured to assess the activity of GTx-758 on hormones secreted by the pituitary, hypothalamus, and adrenal glands.

Mitchell Steiner, CEO of GTx, said: “In this clinical trial, we expect to establish proof of the ability of GTx-758 to reduce testosterone, which is the endpoint required for primary androgen deprivation therapy clinical trials.”

GTx expects to complete this Phase I multiple ascending dose clinical trial in the fourth quarter.

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