Montreal, Canada. October 10, 2012 – MethylGene Inc. (TSX:MYG) today provided a clinical update on MGCD290, the novel, orally available antifungal agent.
Clinical data from four Phase I safety trials of MGCD290 will be presented at the 2012 IDWeek™ meeting, to be held in San Diego, California from October 17-21, 2012. IDWeek™ is a joint meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS).
Poster presentation: SAD and MAD Studies in Healthy Subjects Demonstrate Safety and Pharmacokinetics of MGCD290, an Oral Fungal Hos2 Inhibitor ± Fluconazole
Poster Date and Time: Saturday, October 20, 2012, 12:30 PM - 2:00 PM (PDT)
Session: Novel Antimicrobial Agents (session number 202)
Presentation/Poster Board #: 1619
Location: Halls F-H
Enrollment in the Phase II trial for MGCD290 is proceeding according to plan, and over 150 patients have been enrolled to date. This randomized placebo-controlled, double-blind, multi-center trial is evaluating MGCD290 plus fluconazole versus fluconazole alone in patients with moderate to severe vulvovaginal candidiasis (VVC), a form of yeast infection for which current treatments have limited efficacy. The company projects that enrollment will be completed around mid-November and that topline data will be available in Q1 2013.
MethylGene is presently considering plans to embark on the clinical development of MGCD290 in indications beyond VVC, including invasive fungal infections (IFIs) and onychomycosis.
MethylGene will host an investor event focused on trends in fungal disease today at 8.00 a.m. in New York, New York. This event will be available by live webcast and after the event at the company’s website: www.methylgene.com.
MGCD290 is a first-in-class, orally available, small molecule inhibitor of the fungal enzyme Hos2. Current antifungal therapies suffer from a number of shortcomings including gaps in the coverage of fungal pathogens, acquisition of resistance, toxicity and drug-drug interactions. MGCD290 is initially 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, either as monotherapy or in combination with fluconazole. A randomized, controlled Phase II study in moderate to severe VVC is underway.
MethylGene Inc. (TSX:MYG) is a small molecule drug development company that is advancing two novel therapeutics for 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 is currently in Phase II trials for vulvovaginal candidiasis, and MGCD265, an oral Met/VEGF receptor kinase inhibitor that is in Phase I/II clinical trials for solid tumor cancers. 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.
Investor Relations Contact:
Joseph Walewicz, CFA
Vice President, Business & Corporate Development
Phone: 514-337-3333 ext. 373
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