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METHYLGENE REPORTS SECOND QUARTER 2007 RESULTS
Montreal, Quebec. August 7, 2007 – MethylGene Inc. (TSX:MYG) today announced its operational and financial results for the second quarter ended June 30, 2007.
Highlights
• Presented positive preliminary data at the American Society for Clinical Oncology (ASCO) annual meeting from two clinical trials evaluating MGCD0103 in myelodysplastic syndromes (MDS) and acute myelogenous leukemia (AML) (Trial 005) and in Hodgkin’s lymphoma (Trial 010).
- A 30% response rate, 37% at relevant active doses, was achieved in the Phase I/II combination trial with Vidaza® (Trial 005) in patients with MDS and AML.
- In the single-agent Phase II trial for Hodgkin’s lymphoma (Trial 010), the Company reported a 40% response rate, a 45% disease control rate and 75% of patients on this trial experienced tumor shrinkage.
- MGCD0103 is currently in two Phase I/II combination trials and four single-agent Phase II trials.
• Manufactured MGCD265, our multi-targeted (c-Met) kinase inhibitor, in quantities sufficient to commence investigational new drug (IND)-enabling studies.
• Selected MGCD290 as the Company’s clinical candidate for its histone deacetylase antifungal program. MGCD290 potentiates and broadens the spectrum of azole activity against human fungal pathogens, including azole-resistant clinical isolates.
• Presented data for MGCD290 in two poster presentations at the American Society of Microbiology (ASM).
Financial Results Reported in Canadian Dollars
Total revenues for the second quarter of $3.7 million were $1.1 million higher than for the second quarter of 2006 primarily due to higher clinical trials related revenues received from the Company’s collaborator Pharmion Corporation. Overall expenses of $9.9 million were $3.3 million higher in the second quarter of 2007 versus the second quarter of 2006 due primarily to gross research and development expenditures of $8.8 million which were $3.3 million higher due to increased spending for the clinical development of MGCD0103 and the preclinical development of MGCD265.
At June 30, 2007 MethylGene had $71.0 million in cash, cash equivalents, and short-term investments.
Milestones Anticipated for 2007
• Expect to initiate additional MGCD0103 clinical trials: a Phase I combination trial with Taxotere® in solid tumors (Trial 011) and a Phase II combination trial with Vidaza® in lymphomas (Trial 012). The latter trial will include a run-in bioequivalency study using an updated and improved manufacturing process for MGCD0103 required to support potential pivotal trials which could commence in 2008.
• Continue IND-enabling studies for MGCD265, our multi-targeted kinase inhibitor in anticipation of an IND application by year end.
• Initiate manufacturing studies for MGCD290, our HDAC antifungal inhibitor, to support the commencement of IND-enabling studies.
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 non-oncology programs: MGCD290, an HDAC inhibitor in combination with azoles for fungal infections; an HDAC program for Huntington’s disease; 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 www.methylgene.com.
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
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, 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 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.
For the summary financial statements associated with this press release, please visit www.methylgene.com. |
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