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 and Merck & Co. have established a global strategic collaboration to discover, develop and commercialize current and future selective androgen receptor modulators (SARMs), a new class of drugs with the potential to treat chronic sarcopenia (the loss of skeletal muscle
mass resulting in reduced physical strength and ability to perform activities of daily living)
as well as muscle loss in patients with chronic obstructive pulmonary disease (COPD)
and other musculoskeletal wasting conditions. Merck and GTx are
conducting several Phase I and Phase II clinical trials evaluating multiple SARM product candidates, including Ostarine™ (also designated as MK-2866), which was originally developed at GTx.
GTx also has an extensive preclinical pipeline generated from a proven discovery program that includes the specific product candidate GTx-758, an oral LH inhibitor for advanced prostate cancer, which is in a Phase I multiple ascending dose clinical trial in 2009.
GTx strives to be a good steward of investors’ resources. To date, we have raised approximately $257 million in equity capital. With this capital, we have built a company with a well-defined scientific expertise and a product candidate portfolio rich with opportunities. We have two compounds in late stage clinical development, one of which, toremifene 80 mg, has successfully completed Phase III clinical testing and has been submitted for marketing approval in the United States. We also have the leading SARM program moving forward with Merck as our collaboration partner, as well as our newest molecule from the GTx pipeline, GTx-758, advancing in Phase I clinical trials.