MEDITRINA PHARMACEUTICALS, INC. OPENS INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR PHASE IIB CLINICAL TRIAL WITH MPI-676 IN ENDOMETRIOSIS
- Approval of Second IND Marks Major Corporate Milestone and Advances Clinical Program -
ANN ARBOR, Mich. (July 17, 2008) – 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™ (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 ranging trial will include three treatment arms of anastrozole, all with a fixed dose oral contraceptive in pre-menopausal women diagnosed with endometriosis. The primary endpoint is reduction in endometriosis-related symptoms, primarily pain. Secondary endpoints include quality of life, bleeding patterns and safety outcomes. The goal of the study is to provide data on efficacy and safety of MPI-676, as well as information about feasible endpoints and trial sizes for the planning and execution of the subsequent pivotal Phase III program in endometriosis.
Endometriosis is a serious medical condition where endometrial stroma and glands that are normally present in the uterine cavity are found in other parts of the body. Endometriosis lesions can be found anywhere in the pelvic cavity. The most common symptom of endometriosis is pelvic pain, which often correlates to the menstrual cycle, but a woman with endometriosis may also experience pain that doesn’t correlate to her cycle. For many women, the pain of endometriosis is so severe and debilitating that it significantly impacts their daily lives.
It is estimated that seven to 10 percent of all women are affected by endometriosis, including 70 to 87 percent of women with chronic pelvic pain and 30 to 40 percent of all infertile women. Chronic pelvic pain, dysmenorrhea (painful periods) and dyspareunia (painful intercourse) are common symptoms of women with endometriosis. There are several medical treatment options, including danazol, GnRH agonists and progestins, each of which have limitations associated with patient response, tolerability, side-effect profile and duration of treatment.
About Femathina™ (MPI-674) and MPI-676
Femathina™ (MPI-674) and MPI-676 are based on anastrozole, an aromatase inhibitor (AI) with well-established, multi-year chronic safety and tolerability data. AIs are a class of drugs that reduce the amount of estrogen circulating in the body by binding to and inhibiting the enzyme aromatase, which is responsible for converting certain hormones to estrogen. In endometriosis, AIs act primarily by inhibiting local estradiol production inside the endometrial lesions. AIs are currently used for the chronic treatment of estrogen-dependent tumors in postmenopausal women and are being investigated in a variety of women’s health conditions. Meditrina holds the exclusive worldwide rights to patent applications covering the use of AIs in gynecologic indications, including for endometrial thinning prior to hysteroscopic procedures.
About Meditrina Pharmaceuticals, Inc.
Meditrina Pharmaceuticals, Inc. is a clinical-stage, specialty pharmaceutical company focused on developing and commercializing innovative therapies that treat women’s reproductive system disorders, with an initial focus on gynecologic and aromatase-mediated conditions with serious unmet medical needs. By identifying, leveraging and repurposing marketed products and product candidates at advanced stages of development, Meditrina’s novel therapies have the potential to significantly alter the way these women’s health conditions are treated. For more information about Meditrina Pharmaceuticals, please visit www.meditrina.com.
Meditrina Pharmaceuticals, Inc. Forward-Looking Statement Disclaimer
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.
Femathina is a trademark of Meditrina Pharmaceuticals, Inc.