MethylGene Initiates Phase I Clinical Study With MGCD290 for Fungal Infections

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MethylGene Initiates Phase I Clinical Study With MGCD290 for Fungal

Infections

Oct. 15, 2008

MarketWatch*

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MONTREAL, QUEBEC, Oct 15, 2008 (MARKET WIRE via COMTEX) --

MethylGene Inc. (CA:MYG: news, chart, profile) today announced the

administration of MGCD290 as a single agent to the first cohort of

healthy adult volunteers in a Phase I clinical study. MGCD290 is an

orally available fungal Hos2 inhibitor designed to be used in

combination with azoles for the treatment of fungal infections.

Azoles are a widely-prescribed class of drugs that comprise almost

half of the approximately U.S. $5 billion worldwide antifungal

market.

This double-blind, placebo-controlled Phase I study (Study 290-001),

is expected to enroll up to 60 adult healthy volunteers. MGCD290

will be administered orally at an initial starting dose of 100mg and

dosing levels will increase with each new cohort. The purpose of

this trial is to evaluate MGCD290's safety, pharmacokinetics and

tolerability.

" We continue to make progress with our proprietary product pipeline

and are pleased to have advanced our antifungal program into human

clinical trials. Our goal is to complete single and multiple dosing

in this study followed by combination studies of MGCD290 and

fluconazole in healthy volunteers, " said F. Corcoran,

President and Chief Executive Officer of MethylGene. " In addition,

we will evaluate potential partnering opportunities and funding

requirements prior to advancing MGCD290 into Phase II trials. "

In preclinical studies performed by key antifungal experts, the

combination of MGCD290 with azoles increased the potency of the

azole and expanded its antifungal spectrum of activity. In

particular, the combination of MGCD290 and fluconazole broadened the

spectrum of azole activity in vitro and increased fungal sensitivity

to fluconazole in vitro and in vivo, including fluconazole-resistant

clinical isolates.

" Opportunistic fungal infections are serious because they can invade

every organ in the body, " said Pfaller MD, Professor

Emeritus, Clinical Microbiology at the University of Iowa. " Azoles

are a widely-used treatment for fungal infections; however, they

have limitations and there is a medical need to broaden their

antifungal spectrum, reduce their side effects and allow for more

flexible dosing options. We are encouraged by the significant

synergy we observed in our labs with MGCD290 in combination with

various azoles in clinical-resistant fungal isolates. We look

forward to presenting this data to the scientific community at the

upcoming ICAAC/IDSA conference this month in Washington, DC. "

About MGCD290

MGCD290 is an orally available, small molecule inhibitor that

targets the fungal Hos2 enzyme. This compound was designed to be

used in combination with azoles, a widely-prescribed class of drugs

for the treatment of fungal infections. MGCD290 appears to

potentiate and broaden the antifungal spectrum of azole activity

against human fungal pathogens, including azole-resistant isolates.

The demand for more effective antifungals is driven by a rising

incidence of invasive fungal infections in immunocompromised

patients such as surgical patients, organ transplant patients and

cancer patients undergoing chemotherapy or bone marrow transplants.

Due to these more aggressive medical interventions, the frequency of

invasive fungal infections has increased in this expanding patient

population. Current antifungal agents are limited by an inadequate

spectrum of activity, toxicities, drug-drug interactions and drug

resistance. Emerging infections caused by certain Candida and

Aspergillus species are particularly difficult to treat in

immunocompromised patients and are associated with significant

morbidity and mortality.

About MethylGene

MethylGene Inc. (CA:MYG: news, chart, profile) is a publicly-traded,

clinical stage, biopharmaceutical company focused on the discovery,

development and commercialization of novel therapeutics for cancer.

The Company's product candidates include: MGCD265, an oral, multi-

targeted kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF

receptor tyrosine kinases which is in Phase I clinical trials for

solid tumor cancers; MGCD290, a fungal Hos2 (HDAC) inhibitor used in

combination with azoles for fungal infections which is also in a

Phase I clinical trial; and MGCD0103, an oral, isoform-selective

HDAC inhibitor which has been in multiple clinical trials for solid

tumors and hematological malignancies and is licensed to Celgene

Corporation and Taiho Pharmaceutical. In addition, MethylGene's

preclinical programs include: a kinase inhibitor program for ocular

diseases and a sirtuin inhibitor program for cancer. MethylGene's

development and commercialization partners include Celgene

Corporation, Taiho Pharmaceutical Co. Ltd., Otsuka Pharmaceutical

Co. Ltd. and EnVivo Pharmaceuticals. Please visit our website at

www.methylgene.com.

Certain statements contained in this news release, other than

statements of fact that are independently verifiable at the date

hereof, may constitute forward-looking statements. 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 MGCD0103,

MGCD265 or MGCD290; the ability to scale up, formulate and

manufacture sufficient GMP, clinical or commercialization quantities

of MGCD0103, MGCD265 or MGCD290, 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

MGCD0103, 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, which you are urged to read, as described in

MethylGene's Annual Information Form for the fiscal year ending

December 31, 2007, under the heading 'risk factors,', 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 presentation. These statements speak

only as an update on the date they are made and MethylGene is under

no obligation to revise such statements as a result of any event,

circumstance or otherwise except in accordance with law.

Contacts:

Rx Communications Group, LLC

Rhonda Chiger

917-322-2569

rchiger@...

MethylGene Inc.

F. Corcoran

President & CEO

514-337-3333 ext. 373

mctavishk@...

[Guest guest]

Cool, I hope it is effective and safe.