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Abstract
Results from these preclinical studies demonstrated that MGCD265 combined with docetaxel or paclitaxel achieved greater anti-tumor response than either agent alone and without overt toxicity in lung, breast, gastric, prostate carcinomas and glioblastoma. MGCD265 combined with docetaxel also resulted in a greater reduction of tumor vasculature. Favorable anti-tumor activity with the absence of overt toxicity was also demonstrated when MGCD265 was combined with erlotinib in several xenograft models including breast, gastric and NSCLC carcinomas and a NSCLC model that expressed an EGFR mutation (T790M) which appears to be a predominant mechanism for the development of resistance to erlotinib. In addition, MGCD265 combined with any of the three agents did not result in any drug-drug interactions. These studies help support the selection of erlotinib and docetaxel in an ongoing combination clinical trial (Trial 103, see preliminary results below).
To date, 34 patients have been enrolled in Trial 103, a dose-escalating clinical study combining MGCD265 with either erlotinib or docetaxel. MGCD265 is administered orally, every day for 21 days (one cycle) in patients with advanced solid malignancies. Fifteen patients have been enrolled on the docetaxel arm with MGCD265 (doses up to 144mg/m2) and up to full doses of docetaxel (75mg/m2). A total of 19 patients have been enrolled on the erlotinib arm with MGCD265 (doses up to 144mg/m2) and up to full doses of erlotinib (150mg). In both arms, MGCD265 and the combinations have been well tolerated. The MTD has not been reached in either arm and dose escalation continues. BID tablet dosing is expected to be introduced soon.
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 MGCD265, MGCD290 or mocetinostat (MGCD0103); the ability to scale up, formulate and manufacture sufficient GMP, clinical or commercialization quantities of MGCD265, MGCD290 or mocetinostat, 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 MGCD265, MGCD290 or mocetinostat. 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, as described in MethylGene's Annual Information Form for the fiscal year ending December 31, 2009, under the heading "Risk Factors" which you are urged to read 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.