GTx, Inc. is a company of pioneering and driven individuals who are delivering better medicines with new science through established pathways. Our recognized scientific expertise is in the discovery and development of novel, selective small molecules that target established hormone pathways to prevent and treat cancer, fractures and bone loss, muscle loss and other serious medical conditions. Now in our second decade, we are transforming from a company focused on the discovery and development of drug candidates into one that will also commercialize our products.
Our most advanced drug discovery and development programs are focused on small molecules that selectively modulate the effects of estrogens and androgens.
GTx is developing toremifene citrate, a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a completed pivotal Phase III clinical trial evaluating toremifene 80 mg to reduce the risk of fractures in men with prostate cancer on androgen deprivation therapy (ADT), and second, an ongoing pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN. GTx has made application for marketing approval and, if approved, plans to commercialize toremifene 80 mg in the United States.
GTx has licensed exclusive European rights for toremifene to Ipsen Group. Ipsen’s leading product is Decapeptyl®, an ADT drug. Ipsen has the clinical, regulatory and commercial experience and capabilities to bring toremifene to European patients.
GTx is evaluating Ostarine™ and other selective androgen receptor modulators, or SARMs, for a variety of potential indications, including cancer cachexia, the unintentional loss of muscle mass and body weight in cancer patients, and chronic sarcopenia, which is the loss of skeletal muscle mass resulting in reduced physical strength and ability to perform activities of daily living, and other musculoskeletal wasting conditions. GTx has completed a successful Phase IIb Ostarine clinical trial for cancer cachexia and is now planning the Ostarine Phase III clinical development program.
The latest molecule from GTx’s preclinical pipeline to enter human clinical studies is GTx-758, an oral luteinizing hormone (LH) inhibitor, for the first line treatment of advanced prostate cancer. In February 2010, GTx initiated a Phase II clinical trial evaluating GTx-758.