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news.Repros Therapeutics has released initial findings from evaluation of gross necropsies conducted upon completion of the in-life portion of a two-year study conducted to satisfy the balance of the FDA mandated two-species trials to demonstrate the lack of carcinogenic potential for new chemical entities.
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In a controlled study conducted at MPI Research of Mattawan, Minnesota, Proellex showed no potential for tumor induction as compared to controls in the gross findings. Proellex or the same solution without drug was given orally every day to male and female rats for two years.
Males were examined earlier and individual tissues showed no dose dependent cancer lesions as compared to controls. Female rats were treated at 20, 70 and 200 times the human dose in this two-year study.
Gross necropsy of female rats given the equivalence of a life-time exposure to Proellex demonstrates that Proellex is not a carcinogen based on the lack of gross tumor findings as compared to controls. Tissues removed at necropsy are currently undergoing microscopic evaluation. A final determination of carcinogenic potential is pending.
Joseph Podolski, president and CEO of Repros, said: “We are pleased with the continued excellent progress being made in our new drug application program for Proellex. The lack of evidence of cancer induction is a very favorable response and consistent with our observations of the anti-proliferative and pro-apoptotic properties of the drug.”