MONTREAL, QUEBEC -- (Marketwire) -- 03/18/13 -- MethylGene Inc. (TSX: MYG) today reported topline results from its human efficacy trial (Trial 290-005) with MGCD290, a novel antifungal agent targeting the fungal enzyme, Hos2. Trial 290-005 was a randomized, multicenter, double-blind, placebo-controlled trial designed to test whether MGCD290, in combination with fluconazole, was superior to fluconazole alone in patients with moderate-to-severe vulvovaginal candidiasis ("VVC").
The study showed no statistically significant benefit of MGCD290 plus fluconazole compared to fluconazole alone. There were no serious treatment-related adverse events and non-serious adverse events were evenly distributed between treatment groups. This clinical trial was conducted across nineteen sites in the USA and enrolled 171 patients with positive fungal cultures in their vaginal fluid at baseline. Detailed data will be presented at a future meeting.
"We are disappointed that the study did not demonstrate efficacy of MGCD290 in patients with VVC. We will review the data internally and with key opinion leaders to determine the next steps for the MGCD290 program." said Dr. Charles Baum, President and Chief Executive Officer of MethylGene. "The company's primary focus will continue to be the advancement of our novel oncology compounds. We expect to provide further updates on the oncology programs in the second half of 2013."
MGCD290 is a first-in-class, orally available, small molecule inhibitor of the fungal enzyme Hos2. In preclinical models the combination with azole antifungal agents results in broader coverage of fungal pathogens and decreases resistance to the most widely used antifungal agents. MGCD290 was being developed as a combination product with fluconazole, the most widely used triazole antifungal. In vitro, MGCD290 in combination with fluconazole reverses fluconazole resistance (primary and acquired) in a wide range of fungal species, including Candida glabrata. MGCD290 has completed multiple Phase I studies in healthy adult volunteers and has shown an excellent safety profile without drug-drug interactions in combination with fluconazole.
MethylGene Inc. (TSX: MYG) is a drug development company that is advancing novel therapeutics for the treatment of patients with cancer and infectious disease in human clinical trials. The Company's lead product candidates are: MGCD290, an oral antifungal agent targeting the fungal Hos2 enzyme that was in Phase II trials for vulvovaginal candidiasis, and MGCD265, a multi-targeted receptor tyrosine kinase inhibitor that is in Phase I/II clinical trials for patients with solid tumors. MethylGene owns all rights to its lead product candidates, and has partnerships with Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd., and EnVivo Pharmaceuticals, Inc. for its other pipeline programs.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking information and forward-looking statements (collectively "forward-looking statements" within the meaning of applicable securities laws). Such statements, based as they are on the current expectations of management of MethylGene and upon what management believes to be reasonable assumptions, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene's control. Such statements can usually be identified by the use of words such as "may", "would", "believe", "plan", "estimate" and other similar terminology, or state that certain actions, events or results "may" or "would" be taken, occur or be achieved These risks and uncertainties could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such results, performance or achievements include, but are not limited to, the timing and effects of regulatory action; the continuation of collaborations; the results of clinical trials; the timing of enrollment or completion of clinical trials; the success, efficacy or safety of MGCD265, MGCD290 or our other programs; the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD265, MGCD290 or our other products, and the relative success or the lack of success in developing and gaining regulatory approval and/or market acceptance for any compound or new product including MGCD265 or MGCD290.
Such risks include, but are not limited to, the impact of general economic conditions, economic conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which MethylGene does business, stock market volatility, fluctuations in costs, expectations with respect to our intellectual property position and our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others, changes in the competitive landscape including changes in the standard of care for the various indications in which MethylGene is involved, and changes to the competitive environment due to consolidation, as well as other risks, as described in MethylGene's Annual Information Form under the heading "Risk Factors" which you are urged to read, and all other documents filed by the Company that can be found at www.sedar.com. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance on the forward-looking statements included in this news release. These statements speak only as of the date they are made and MethylGene expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in MethylGene's expectations with regard thereto of any change in events, conditions or circumstances on which any such statements are based except in accordance with law.
Investor Relations Contact:
Mark J. Gergen
Executive Vice President & COO
Tracey Rowlands, Ph.D.
Manager Business and Corporate Development
514-337-3333 ext. 512
The Trout Group LLC
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