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Meditrina Pharmaceuticals, Inc. Opens Investigational New Drug (IND) Application for Phase IIb Clinical Trial With MPI-676 in Endometriosis
Date:7/17/2008

- Approval of Second IND Marks Major Corporate Milestone and Advances

Clinical Program -

ANN ARBOR, Mich., July 17 /PRNewswire/ -- Meditrina Pharmaceuticals, Inc. today announced the approval of its second investigational new drug (IND) application for a Phase IIb dose ranging clinical trial to study MPI-676, the Company's aromatase inhibitor (AI), in combination with estrogen and progestin for the treatment of endometriosis. MPI-676 is the newest addition to Meditrina's clinical stage product portfolio that currently includes Femathina(TM) (MPI-674), an AI that Meditrina is repurposing for the treatment of endometrial thinning prior to endometrial ablations in premenopausal women with abnormal uterine bleeding. Meditrina recently completed a global licensing agreement to make, develop and commercialize products, including MPI-676, under AstraZeneca's IP and know-how regarding the use of AIs in combination with estrogen and progestin to treat endometriosis.

"This IND for MPI-676 marks another major milestone in our robust clinical program focused on addressing women's reproductive system disorders," said James Symons, Ph.D., Vice President, Clinical Development, Meditrina Pharmaceuticals, Inc. "Based on the encouraging proof of concept and strong safety data established for MPI-676, we look forward to selecting the dose for Phase III pivotal trials, which will be at a dose lower than for which AstraZeneca has already established two-year chronic use safety data in their breast cancer prevention trials and is cited in the anastrozole product label. These data will advance development of MPI-676 and help us bring this important new treatment to women suffering from endometriosis, a painful and debilitating condition."

This US-based, multi-center, placebo-controlled, double-blinded study will identify the maximally efficacious dose of MPI-676 to investigate in the pivotal Phase III program. The Phase IIb dose ra
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