Ipsen Group has licensed European toremifene rights from GTx and is planning to submit a marketing application in 2009 in its licensed territories for the use of toremifene 80mg for this indication.
The submission is supported by results from a two year, double blind, placebo controlled, randomized Phase III clinical trial of 1,382 men with advanced prostate cancer on androgen deprivation therapy (ADT). Toremifene has been marketed for the treatment of advanced breast cancer in more than 60 countries including the US.
Mitchell Steiner, CEO of GTx, said: ADT has helped improve survival for men with advanced prostate cancer. Unfortunately, ADT may cause unintended serious estrogen deficiency side effects, such as a high risk of fractures, which can shorten survival. If approved, toremifene 80mg could become the first cancer care agent for the prevention of fractures in men receiving ADT.
GTx, headquartered in Memphis, is a biopharmaceutical company which is into discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions.