The Men’s Health Biotech Company, GTx, Inc., recently announced that it is going into a separate Phase IIIb clinical trial as an extension of the pivotal Phase III ADT clinical trial of ACAPODENE® (toremifene citrate) in an 80mg dose for the treatment of multiple serious side effects of androgen deprivation therapy.
Androgens (such as testosterone) are male hormones produced mainly in the testicles that can actually stimulate prostate cancer cells to grow and so ADT or androgen deprivation therapy is the lowering of male hormones in prostate cancer patients to make the tumor shrink.
"This new clinical trial is a unique opportunity to continue to follow in a blinded fashion ADT patients completing our two year pivotal Phase III study. It will allow us not only to obtain additional data regarding fractures and safety, but also to evaluate other possible benefits of ACAPODENEâ in this population," said Mitchell S. Steiner, M.D., CEO of GTx.
The primary and secondary objectives of this new clinical trial is a reduction in vertebral fractures and improvements in bone mineral density and cholesterol levels, a reduction in hot flashes, and the treatment of gynecomastia: side effects of androgen deprivation therapy.
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