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news.GTx, a biopharmaceutical company, has initiated a Phase I clinical trial for GTx-758, an oral luteinizing hormone inhibitor to treat men with advanced prostate cancer.
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The Phase I study will evaluate the safety, tolerability and pharmacokinetic profile of GTx-758 using a single ascending dose, double-blind, placebo-controlled design in healthy male volunteers.
Preclinical in vitro and in vivo data suggest GTx-758 rapidly suppresses secretion of LH, thereby inhibiting production of androgens by the testes. GTx-758 has the potential to reduce testosterone, a primary growth factor of prostate cancer and also does not cause certain side effects such as bone loss and hot flashes which are common with current androgen deprivation therapies (ADT) for prostate cancer.
Mitchell Steiner, CEO of GTx, said: We are excited to initiate Phase I clinical studies of GTx-758, which was discovered in GTx’s labs and is our fourth clinical development program. We believe GTx-758, with an oral formulation and the potential to treat prostate cancer through suppression of testosterone without also causing bone loss and hot flashes could become best in class androgen deprivation therapy. We expect to establish proof of concept in man in a second Phase I clinical trial later in 2009.