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news.Repros Therapeutics has said that the company's investigational new drug or IND application for the study of Proellex in the treatment of anemia associated with uterine fibroids has become effective.
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The company will open the IND with two identical registration quality Phase III studies. The work has been awarded to an appropriate CRO. This IND is based on impressive clinical findings from a subset of anemic patients in a Phase IIb trial of Proellex in the treatment of uterine fibroid symptoms.
Joseph Podolski, president and CEO, said: “We are pleased with the progress we are making with Proellex. We will make every effort to rapidly enroll subjects into these registration studies. At the same time we will diligently complete the other ancillary work the FDA will require before we can submit our first Proellex NDA. Though our goal for NDA submission is aggressive we will make every effort to submit the dossier around year-end 2008.”