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METHYLGENE PRESENTS CLINICAL BIOMARKER DATA FOR MGCD0103 AND PRECLINICAL EFFICACY DATA IN COMBINATION WITH TAXANES AT AACR ANNUAL MEETING
Montreal, Quebec. April 14, 2008 - MethylGene Inc. (TSX:MYG) today disclosed clinical biomarker data for its isoform-selective histone deacetylase (HDAC) inhibitor, MGCD0103, as well as preclinical efficacy data when MGCD0103 is administered in combination with taxanes. The data were presented in two poster sessions and one oral presentation at the American Association for Cancer Research (AACR) Annual Meeting in San Diego.
In an oral presentation by our partner Taiho Pharmaceutical Co. Ltd. entitled, “MGCD0103, an Oral Isotype-selective HDAC Inhibitor, Significantly Enhances the Anti-tumor Efficacy of Taxanes via the Unique Modulation of Angiogenesis Gene Expression,” data showed that MGCD0103 is effective in xenograft models against several solid tumors as a single-agent, and potentiated the anti-tumor efficacy of the taxanes Taxol(R) and Taxotere(R). In addition, MGCD0103 enhanced TSP-1 expression and reduced the expression of the angiogenic-related ligands VEGF and bFGF in tumors.
In a poster presentation entitled, “Induction of an Anti-angiogenesis Factor, Thrombospondin 1 (TSP-1), by a Novel HDAC Inhibitor, MGCD0103, in Human Cancer Cells in vitro and in vivo,” (poster #739), results demonstrated that MGCD0103 induced the transcription of the anti-angiogenic and pro-apoptotic factor, TSP-1. Previously disclosed data showed MGCD0103’s preliminary anti-tumor clinical activity in Phase II clinical trials, including patients with acute myelogenous leukemia (AML). The mechanism of action of MGCD0103 was investigated to determine if the compound also demonstrated anti-angiogenic activity. MGCD0103 significantly inhibited growth of cultured human endothelial cells in a dose-dependent manner in vitro and induced the transcription of TSP-1 in human cancer cells in vitro, independent of tissue origin. Preliminary analysis of peripheral blood mononuclear cells or bone marrow cells from AML patients treated with MGCD0103 alone or in combination with Vidaza(R), indicated that the expression of TSP-1 was significantly upregulated in the AML patients who achieved a clinical response, but not in the non-responding AML patients. Therefore, TSP-1 may be a novel biomarker for clinical activity in AML patients.
In a second poster presentation entitled, “Elucidating the Role of Class I and Class II Histone Deacetylases in Regulation of NDRG1 in Prostate Cancer,” (poster #748), MethylGene’s HDAC inhibitors were shown to upregulate the N-myc downregulated gene 1 (NDRG1). NDRG1 is a known prostate cancer metastasis suppressor gene. The induction of NDRG1 led to the differentiation of prostate cancer cells and decreased metastasis. Therefore, the ability to pharmacologically control the expression of NDRG1 in prostate cancer could potentially reduce metastasis.
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded, clinical stage, biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral, isoform-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase I, Phase I/II and Phase II combination trials with Vidaza(R), Gemzar(R) and Taxotere(R). MGCD265 is an oral, multi-targeted kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. The initial Phase I clinical trial for this compound is expected to commence in April 2008. In addition, MethylGene’s preclinical programs include: MGCD290, an HDAC inhibitor in combination with azoles for fungal infections, a kinase inhibitor program for ocular diseases, and a sirtuin inhibitor program for cancer. MethylGene's development and commercialization partners include Celgene Corporation, Otsuka Pharmaceutical Co. Ltd., Taiho Pharmaceutical 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.
Investor Relations Contacts:
Donald F. Corcoran
President & CEO
MethylGene Inc.
Phone: 514-337-3333 ext. 373
mctavishk@methylgene.com
Rhonda Chiger
Rx Communications Group, LLC
Phone: 917-322-2569
rchiger@rxir.com
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