thepharmaletter.com/file/769 … dy-ag.html
March 16, 2010
GTx will move Ostarine into Ph III testing
Announcing the end of its collaboration with Merck & Co, GTx says it now reacquires full rights to Ostarine and rest of SARM program and plans to advance the product into Phase III clinical trials for the treatment of cancer cachexia.[i]Is this just a conicidence, or does Merck know something that they don’t want anybody to know, thus abandoning the relationship to dismiss guilt?[/i] GTx completed a successful Phase IIb Ostarine clinical trial for cancer cachexia in October 2008 and now plans to have an End of Phase II meeting with the US Food and Drug Administration to discuss the Ostarine Phase III clinical development program.
Mitchell Steiner, chief executive of the Memphis-based biopharmaceutical company, said: “It was a difficult decision to dissolve our SARM collaboration with Merck. GTx’ near term objective is to generate revenue so that we can transition to a self-sustaining company. Reacquiring Ostarine moves us toward this objective by allowing us to advance our lead SARM into Phase III clinical studies in cancer cachexia which is a large commercial opportunity for our company and a critical unmet medical need for cancer patients.”
Ostarine is an oral agent that has demonstrated the ability to increase lean body mass and improve muscle strength and performance in postmenopausal women, elderly men and men and women with cancer cachexia. The product is GTx’ lead SARM which has been studied in seven Phase I, Phase II, and Phase IIb clinical trials in 582 subjects.