- Approval of Second IND Marks Major Corporate Milestone and Advances Clinical Program - ANN ARBOR, Mich., July 17
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 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
tacollet@meditrina.com
SOURCE Meditrina Pharmaceuticals, Inc.
