MethylGene Inc.

MethylGene Inc.

October 02, 2007 08:02 ET

MethylGene Provides Corporate Update at its Investor Event

MONTREAL, QUEBEC--(Marketwire - Oct. 2, 2007) - MethylGene Inc. (TSX:MYG) will today provide a corporate update at its Investor Event in New York City. The Company's management and guest speakers will review the development status of the Company's programs, including MGCD0103 (histone deacetylase inhibitor for oncology), MGCD265 (kinase/c-Met inhibitor for oncology) and MGCD290 (histone deacetylase inhibitor for fungal infections).

MGCD0103 - Histone Deacetylase Inhibitor

MethylGene has submitted abstracts for potential presentation at medical conferences to take place before the end of 2007. The abstracts outline additional clinical trial data for MGCD0103, the Company's oral isotype-specific HDAC inhibitor for cancer.

- Preliminary Phase I data from the Phase I/II MGCD0103 combination trial with Gemzar® for the treatment of solid tumors (Trial 006) was accepted for a poster presentation at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference to be held October 22 to 26, 2007 in San Francisco, California.

- Preliminary data from the single-agent Phase II trial in patients with relapsed or refractory Hodgkin's lymphoma (Trial 010) was accepted for oral presentation at the 7th International Symposium on Hodgkin's Lymphoma that will take place November 4 to 7, 2007 in Cologne, Germany.

- The Company intends to provide updates for the following trials at upcoming medical conferences and/or by news release: single-agent Phase II trial in patients with relapsed or refractory Hodgkin's lymphoma (Trial 010); Phase I/II combination trial with Vidaza® in patients with acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS) (Trial 005); and a single-agent Phase II trial in diffuse large B-cell lymphoma and follicular lymphoma (Trial 008).

MethylGene continues enrollment for the Phase I/II combination trial with Gemzar® (Trial 006) and the single-agent Phase II trial in refractory chronic lymphocytic leukemia (Trial 009). For the Phase I/II combination trial with Vidaza® (Trial 005), patient enrollment in high-risk MDS and AML patients has been completed per protocol. This trial has been amended to focus and enroll additional patients with low-risk MDS.

Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma patients continue to be enrolled in the Phase II monotherapy trial (Trial 008). Enrollment in the DLBCL indication is expected to be completed by the end of 2007 and enrollment in patients with follicular lymphoma will continue into 2008. The Company intends to enroll approximately 40 patients in each patient population.

MethylGene discloses that Trial 007, a Phase II clinical trial with MGCD0103 as a single agent in AML and MDS patients, has been amended to focus on elderly, untreated AML patients for whom an oral therapy such as MGCD0103 may be desired.

MethylGene reiterates that Trial 010 (single-agent Phase II trial in patients with relapsed or refractory Hodgkin's lymphoma) is expected to be fully enrolled by the end of 2007 (approximately 35 patients). The protocol for this trial is being amended to expand enrollment in order to obtain additional patient experience during the remainder of 2007 and into 2008 using an 85mg oral dose.

MethylGene, along with its collaborator Pharmion Corporation (NASDAQ:PHRM), expect to initiate a Phase I combination trial with Taxotere® in patients with solid tumors (Trial 011) and a Phase II combination trial with Vidaza® in lymphomas (Trial 012) by the end of 2007. Trial 012 will include a pharmacokinetic equivalency study using an updated and improved manufacturing process for MGCD0103 required to support pivotal trials and commercialization. This manufacturing process appears to have improved the stability, process control and purity of MGCD0103 drug product required for commencement of such trials. In addition, MethylGene and Pharmion continue to optimize the formulation for MGCD0103 finished product.

MethylGene and Pharmion are also planning a three-arm, randomized Phase II trial (Trial 013) in acute myelogenous leukemia (AML) which is expected to begin in the first quarter 2008. This trial will test the combination of MGCD0103 and Vidaza® against MGCD0103 as a single agent and Vidaza® as a single agent. The protocol is an adaptive design which will drop the most inferior arm as results are accumulated.

Including the above-mentioned new trials, MGCD0103 is expected to be in nine different clinical trials. A key purpose of these trials is to obtain sufficient data to identify potential registration pathways for MGCD0103. As data continues to be compiled during the remainder of 2007 and into 2008, the Companies (MethylGene and its partners Pharmion and Taiho) intend to approach the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) to discuss pivotal trial design in refractory or relapsed Hodgkin's lymphoma and potentially other indications. The selection of a specific tumor indication and pivotal design is ultimately dependent on a number of factors that will be discussed with the regulatory agencies and agreed to by the Companies. If it is decided by Pharmion and MethylGene that an initial pivotal trial will be in the Hodgkin's lymphoma indication, the intention is to commence such a trial prior to the end of 2008. Should an alternative or additional indication be identified by the Companies, our intention is to provide an update at the time of such selection.

MGCD265 - Multi-targeted (c-Met) Kinase Inhibitor

The Company will describe preclinical data and the ongoing Investigational New Drug (IND)-enabling studies in order to support the intended filing of an Investigational New Drug (IND) by year end. Potential clinical development strategies will also be presented.

MGCD290 - Histone Deacetylase Antifungal Inhibitor

MethylGene will also present preclinical data for MGCD290, including single-agent and combination studies in clinical isolates of multiple fungal species. GMP manufacturing development has commenced for MGCD290 IND-enabling studies. The Company recently held a Clinical Advisory Board meeting to further advance the Phase I and Phase II planning for this product candidate. An IND is expected to be filed mid-2008. The Company currently intends to partner this program in the future. The selection of one or two azoles for IND-enabling studies in combination with MGCD290 is currently being determined.

About MethylGene

MethylGene Inc. (TSX: MYG) is a publicly-traded biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for cancer. The Company's lead product, MGCD0103, is an oral isotype-selective HDAC inhibitor presently in multiple clinical trials for solid tumors and hematological malignancies, including Phase II monotherapy and Phase I/II combination trials with Vidaza® and Gemzar®. MGCD265 is an oral kinase inhibitor targeting the c-Met, Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has several preclinical programs: MGCD290 an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington's disease; a sirtuins program for cancer; and a beta-lactamase program to overcome antibiotic resistance. MethylGene's development and commercialization partners include Pharmion Corporation, Taiho Pharmaceutical and EnVivo Pharmaceuticals. Please visit our website at

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 ability to demonstrate pharmacokinetic / bioequivalency; 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, 2006, under the heading 'risk factors,' the final prospectus filed on February 23, 2007, and all other documents filed by the Company that can be found at 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.

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