MONTREAL, CANADA--(Marketwire - Dec. 19, 2012) - MethylGene Inc. (TSX:MYG) today announced that it has completed enrollment in its multi-center, randomized, double-blind, placebo-controlled trial (Trial 290-005) evaluating MGCD290 plus fluconazole versus fluconazole alone in patients with moderate-to-severe vulvovaginal candidiasis (VVC).
"We are pleased to announce that we have completed enrollment in our first Phase II trial of MGCD290," said Dr. Chuck Baum, President and Chief Executive Officer of MethylGene. "MGCD290 is a novel antifungal agent with the potential to significantly improve outcomes for patients suffering from fungal infections, including VVC."
Trial 290-005 began enrolling patients with moderate to severe VVC in the first quarter of 2012, and over 200 patients were enrolled at 19 sites in North America.
The primary endpoint for the study is Therapeutic Cure at Day 28, which is a composite endpoint of Clinical Cure (resolution of signs and symptoms of the infection) and Mycological Cure (an absence of yeast in culture). The primary endpoint will be based on the modified intent to treat (MITT) population, which includes those patients who received treatment and were culture positive for yeast at baseline. Secondary endpoints include the Clinical and Mycological Cure rates at Day 14 and Day 28, Therapeutic, Clinical and Mycological Cure rates at day 14, recurrence rate at Day 28, and time to recurrence.
Topline data are expected in March of 2013.
About Vulvovaginal Candidiasis (VVC)
VVC is a yeast infection that affects an estimated 75% of healthy women at least once in their lifetimes, and treatments include topical over-the-counter antifungal agents and oral fluconazole. In 2011, over 11.5 million prescriptions were written in the US for fluconazole 150mg, which is only indicated for VVC and considered effective for patients with mild disease. However, there is only limited benefit for women with moderate to severe infections. VVC is most commonly caused by the type of fungus known as Candida albicans, although Candida glabrata is thought to be the cause of 10-15% of infections, with non-albicans strains which are azole-resistant being more prevalent in growing sectors of the population such as diabetics. Despite the medical need, few agents are currently in development for VVC.
MGCD290 is a first-in-class, orally available, small molecule inhibitor of the fungal enzyme Hos2. In preclinical models the combination of MGCD290 with azole antifungal agents results in broader coverage of fungal pathogens and decreases resistance to the most widely used antifungal agents. 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 a favourable safety profile without drug-drug interactions in combination with fluconazole. A randomized, controlled Phase II study in moderate to severe VVC has recently completed accrual.
MethylGene Inc. (TSX:MYG) is a drug development company that is advancing 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 in a Phase II trial 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 statement. Such statements, based as they are on the current expectations of management of MethylGene, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond MethylGene's control. 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.