Meditrina Pharmaceuticals, Inc. Initiates Phase II Trial and Raises$4.4M in Initial Funding- Newly Formed Company's Lead Product Candidate May Significantly Improve Treatment Standard for Millions of Women Suffering from Abnormal Uterine Bleeding (AUB) -
ANN ARBOR, Mich., April 04, 2007 /PRNewswire/ -- Meditrina Pharmaceuticals, Inc., today announced the start of its phase II clinical trial for its lead product candidate, Femathina(TM) (MPI-674). MPI-674 is an aromatase inhibitor that Meditrina is repurposing for the treatment of several serious women's health conditions including endometrial thinning prior to endometrial ablations in premenopausal women with abnormal uterine bleeding (AUB). In addition, Meditrina has secured $4.4M in initial funding from the 21st Century Jobs Fund administered by the Michigan Economic Development Corporation and from the Biosciences Research and Commercialization Center at Western Michigan University to advance the Company's initiatives.
Meditrina is currently enrolling women in a US-based, multi-center, placebo-controlled study that will evaluate the appropriate time during the menstrual cycle in which to initiate dosing in premenopausal women to either induce or maintain a thin endometrium (protocol M001). The primary objective is to establish appropriate times during the menstrual cycle to dose MPI-674 in order to induce or maintain a thinned endometrium. The issue of timing during the menstrual cycle is crucial in order to progress into a subsequent phase II dose ranging trial (M002), as well as a larger pivotal phase III trial (M003), the latter of which is scheduled to commence in early 2008.
"Approval of our first IND by the FDA and initiation of this clinical study mark major milestones for Meditrina," said Thomas A. Collet, president and CEO, Meditrina Pharmaceuticals, Inc. "We are delighted to advance our MPI-674 clinical program with the goal of demonstrating our lead product's potential to improve the practice standard for the millions of patients suffering from women's health conditions with serious unmet needs such as AUB and to treat other gynecologic diseases like endometriosis and uterine fibroids that may benefit from inhibition of aromatase."
AUB is a significant medical problem that affects more than three million women in the US and is one of the most common reasons women see their gynecologists. AUB is an all-encompassing diagnosis referring to any vaginal or uterine bleeding that is irregular with regard to amount, duration or timing and may or may not be related to a woman's menstrual cycle. Occurring at any age, AUB accounts for more than a third of all gynecologic visits and is the indication for more than 25 percent of all gynecologic surgeries. Causes of AUB include: changes in hormonal balance; pregnancy; miscarriage; ectopic pregnancy; problems linked to some birth control methods, such as an intrauterine device (IUD) or birth control pills; infection of the uterus or cervix; fibroids; problems with blood clotting; polyps; certain types of cancers, such as cancer of the uterus, cervix, or vagina; and, chronic medical conditions such as diabetes.
While treatment for AUB varies by cause, nearly half of all women diagnosed with AUB undergo hysterectomies. New minimally invasive procedures called endometrial ablation can address AUB by destroying the lining of the endometrium in women who have finished childbearing and offer an attractive alternative to hysterectomy.
"MPI-674 may offer physicians and patients a more convenient, safer, and cost-effective treatment option to ensure the endometrium is appropriately prepared for the endometrial ablation and ensure optimal patient outcomes," added Collet.
MPI-674 is an aromatase inhibitor (AI) with a well-established, multi-year chronic safety and tolerability profile. 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. 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.
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.
Posted: April 2007