GTx has announced a second Phase I clinical trial evaluating GTx-758, an oral luteinizing hormone (LH) inhibitor (not an LHRH agonist or an LHRH antagonist), for first-line treatment of advanced prostate cancer.
A prior Phase I clinical trial in 96 subjects was completed in June.
The ongoing Phase I multiple ascending dose clinical trial will evaluate the safety, tolerability, and pharmacokinetic profile of GTx-758. In addition, clinical serum levels of testosterone and other hormones will be measured to assess the activity of GTx-758 on hormones secreted by the pituitary, hypothalamus, and adrenal glands.
GTx-758 is an oral LH inhibitor which is being developed for the treatment of advanced prostate cancer. Currently available data suggest that GTx-758 rapidly suppresses secretion of LH, thereby inhibiting production of androgens by the testes. GTx has stated trhat, in the company’s opinions, GTx-758 has the potential to reduce testosterone without causing bone loss and hot flashes.