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METHYLGENE REPORTS PRECLINICAL RESULTS OF ITS ANTIFUNGAL COMPOUND MG3290 IN COMBINATION WITH AZOLES
- Posters Presented at Two Scientific Conferences: 46th Annual ICAAC Conference and 3rd Annual North American Genetic ABC Workshop -
Montreal, Quebec. September 29, 2006 – MethylGene Inc. (TSX:MYG) reported in vitro preclinical results further supporting the antifungal potential of MG3290 in human fungal infections. The poster presentations were held at the 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, CA and at the 3rd Annual North American Genetic ABC Workshop in Frederick, MD.
Data demonstrate that MG3290, a histone deacetylase (HDAC) inhibitor specific to fungi, when added to the marketed antifungal azoles: itraconazole (Sporanox®) and voriconazole (Vfend®), increased the potency of the azole therapies against Candida glabrata, a common yeast infection. MG3290 concentrations that were used in the study were equal to or less than 0.25 mcg/ml, which is at least 20-fold lower than concentrations toxic to mammalian cells. Moreover, MG3290 also potentiated azole activity against azole-resistant Candida glabrata strains, including clinical strains.
“This is additional encouraging data for our HDAC fungal program. Fungal infections are becoming more difficult to treat with currently available therapeutics in immunocompromised patients, including cancer patients. The ability of our compound to synergize and potentiate with widely-accepted azoles could result in a new paradigm for the treatment of these often life-threatening infections,” said Donald F. Corcoran, President and Chief Executive Officer, MethylGene Inc. “We look forward to further progressing this program and maintain the goal of identifying a clinical candidate for the fungal program in 2007.”
Treatment with azoles, a commonly used class of drugs for the treatment of fungal infections, often results in the emergence of resistant fungal strains, thereby rendering the azole treatment ineffective over time. It is believed that the fungi become resistant to azole treatment through the action of certain fungal HDAC isoforms. These isoforms affect expression of key fungal genes that allow the organism to develop resistance to azoles. MethylGene’s previously reported in vivo studies demonstrated that combining leading azoles with MG3290 rendered azole treatment more effective at decreasing the extent of fungal infection and increasing animal survival in a dose-dependent manner. The ability of MG3290 to lower the effective dose of azoles in animals may lead to fewer side effects and less drug-to-drug interactions associated with azoles. Most importantly, MG3290 may extend azole coverage to a broader range of fungal pathogens and to some drug-resistant fungi.
Candida glabrata is a yeast that is increasingly resistant to azole therapy and is the second most common cause of candidiasis. Candididasis can range from rashes to invasive and fatal infections, particularly in immunocompromised patients.
The poster entitled, “Potentiation of Azole Antifungal Activity by MG3290, a Selective Histone Deacetylase (HDAC) Inhibitor, in Azole-Resistant Mutants of Candida glabrata” was presented at the 3rd Annual North American Genetic ATP-Binding Cassette Workshop in Frederick, MD (September 21-22, 2006). The poster entitled, “Potentiation of Azole Antifungal Activity by MG3290, a Selective Histone Deacetylase (HDAC) Inhibitor, in Candia glabrata” was presented at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, CA (September 27-30, 2006). Details regarding these posters and studies can be found on MethylGene’s web site at www.methylgene.com.
About MG3290
MG3290 is a histone deacetylase (HDAC) inhibitor being developed as part of MethylGene’s HDAC drug discovery platform for oncology and other diseases. It is an orally available, small molecule HDAC inhibitor that appears to target fungal HDACs preferentially to human HDACs. MG3290 potentiates azole activity broadly against human fungal pathogens, including some azole-resistant isolates.
MG3290 and related compounds are presently being tested in animal models of systemic infections in combination with various marketed azoles with the goal of nominating a molecule for IND-enabling GLP toxicology and safety studies in 2007.
About Fungal Infections
Serious infections with yeasts and other fungi often occur in hospital settings as a complication in immunocompromised patients, including cancer patients. Fungal infections are commonly treated with a class of drugs called azoles. However, not all human fungal pathogens are susceptible to azole antifungal medications and resistance is an increasing problem. Infections caused by certain Candida and Aspergillus species are especially common and difficult to manage medically. Aspergillosis has a high mortality rate, approximately 85%, and is an underserved market. In 2004, the market for systemic antifungal drugs was estimated to be $3 billion USD worldwide with azole sales being a major contributor to that market.
About MethylGene
MethylGene is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics in cancer. Two cancer product candidates are currently in clinical trials: MGCD0103, partnered with Pharmion Corporation and Taiho Pharmaceutical Co., Ltd., and MG98, partnered with MGI Pharma, Inc. MethylGene has an exclusive license agreement with Merck & Co. for the development and commercialization of small molecule beta-lactamase inhibitors to overcome antibiotic resistance. MethylGene has partnered its non-oncology HDAC program for neurodegenerative diseases with EnVivo Pharmaceuticals. MethylGene has a portfolio of preclinical programs for its multi-targeted kinase and histone deacetylase (HDAC) inhibitors for both oncology and non-oncology indications, and continues to seek partnering opportunities in these areas. 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 or MG98; 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 and MG98. 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, 2005, under the heading "risk factors,” 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.
Investor Relations Contacts
Rhonda Chiger
Rx Communications Group, LLC
Phone: 917-322-2569
rchiger@rxir.com
Donald F. Corcoran
President & CEO
MethylGene Inc.
Phone: 514-337-3333 ext. 373
mctavishk@methylgene.com
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