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 /EMWNews/ -- 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 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(TM) (MPI-674) and MPI-676



    Femathina(TM) (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 http://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.



    Contact:

    Thomas A. Collet

    President and CEO

    Meditrina Pharmaceuticals, Inc.

    +1 (734) 926-0966

    [email protected]