MethylGene Reports Clinical Data for MGCD265
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MethylGene Inc. has announced that it has presented results for the Company's Phase 1 clinical trial (Trial 265-102), in which MGCD265 was administered as a single agent on an intermittent schedule in patients with advanced disease that was refractory to standard therapy.
MGCD265 is the company's proprietary oral Met/VEGF receptor tyrosine kinase inhibitor.
The trial results were presented on Sunday, November 13, 2011 in a poster session at the 2011 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics held in San Francisco, California.
"We are pleased that MGCD265, when dosed in an intermittent (week on, week off) schedule, was very tolerable for patients and showed early signs of clinical benefit," commented Dr. Jeff Besterman, Chief Scientific Officer of MethylGene.
Dr. Besterman continued, "The excellent tolerability of MGCD265 in this intermittent schedule was consistent with the continuous dose regimens used in Trials 265-101 and 265-103. We continue to enroll patients in Trials 265-101 and 265-103, and we will report additional data from these ongoing studies in 2012."
Poster Session
"The Determination of the Maximum Tolerated Dose (MTD) of MGCD265 on an Intermittent Schedule: Phase I Study Results (Study 265-102)" Abstract #A95.
Forty-seven patients were enrolled in this Phase 1, open-label, dose-escalation study to evaluate the safety and MTD of oral MGCD265 as a single agent when dosed intermittently.
MGCD265 was administered daily (one week on, one week off) to patients with a variety of advanced solid malignancies for 28-day cycles. There were no treatment-related serious adverse events (SAEs).
The most frequent treatment- related adverse events were diarrhea, fatigue and nausea, and most were of modest severity (grade 1 or 2).
Dose-limiting toxicities were grade 3 mood alteration and grade 3 fatigue in one patient, and grade 3 hemoptysis in another patient.
The MTD in this single agent study was determined to be 128 mg/m2 twice daily (BID). In this group of patients with advanced disease treated with MGCD265, 4 had prolonged stable disease (6-14 cycles).
