GTx, Inc. (Nasdaq: GTXI), announced the initiation of a 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 the completed 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.
"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," said GTx CEO Mitchell S. Steiner, MD.
GTx expects to complete this Phase I multiple ascending dose clinical trial in the fourth quarter.
About GTx-758
GTx-758 is an oral LH inhibitor which GTx is developing for the treatment of advanced prostate cancer. Preclinical in vitro and in vivo data suggest GTx-758 rapidly suppresses secretion of LH, thereby inhibiting production of androgens by the testes. GTx believes GTx-758 has the potential to reduce testosterone, a primary growth factor of prostate cancer, without causing bone loss and hot flashes.
Prostate cancer is the second most common type of cancer diagnosed in men in the U.S. An estimated 186,000 new cases of prostate cancer were diagnosed in the U.S. in 2008. Approximately 700,000 men with prostate cancer are being treated with androgen deprivation therapy (ADT) and an estimated 100,000 initiate ADT each year. Annual US sales of drugs for ADT exceeded $1.7 billion in 2008.
Source
GTx, Inc.