MethylGene Reports Results of Phase II Trial of MGCD290
March 18 2013 - 08:15AM
Marketwired
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."
About MGCD290
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.
About MethylGene
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.
Contacts: Investor Relations Contact: MethylGene, Inc. Mark J.
Gergen Executive Vice President & COO 858-546-2902 MethylGene,
Inc. Tracey Rowlands, Ph.D. Manager Business and Corporate
Development 514-337-3333 ext. 512ir@methylgene.com
www.methylgene.com The Trout Group LLC Thomas Hoffmann Vice
President 646-378-2931thoffmann@troutgroup.com
www.troutgroup.com