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Verastem Successfully Completes Phase 1 Stage of Combination Trial of Cancer Stem Cell Inhibitor VS-6063 and Paclitaxel
--Four of six patients continuing on study and significant reduction in CA-125 observed--
--Phase 1b portion of the study is now open for enrollment--
The dose escalation reached the anticipated dose of 400mg BID in combination with weekly paclitaxel without any dose-limiting toxicities. 400mg BID is the recommended Phase 2 dose for VS-6063 as a single agent. In total, 6 patients with ovarian cancer have been treated in the first stage of the Phase 1/1b trial and four patients are continuing on study. A significant CA-125 reduction was observed in 3 patients. CA-125 is a marker that becomes elevated with disease progression in ovarian cancer.
“The combination of VS-6063 and weekly paclitaxel has been well
tolerated, with no unexpected toxicity, and no worsening of the well
understood side effects of paclitaxel," said Principal Investigator
“The initial results from this trial are promising,” said Dr.
VS-6063 targets cancer stem cells through potent inhibition of focal
adhesion kinase (FAK). Research by
“We are very pleased with the initial results of the study and the
potential of this combination for patients,” said
The expansion stage of the trial will evaluate the single agent pharmacodynamic activity of VS-6063 on biomarkers and cancer stem cells in paired tumor biopsies collected prior to the addition of weekly paclitaxel. Anti-tumor activity will then be assessed by Response Evaluation Criteria for Solid Tumors (RECIST) and safety and pharmacokinetics will be monitored. Up to 15 additional patients will be enrolled in this second stage of the study at three U.S. locations.
“Our mission is to develop new medicines that target cancer stem cells
in order to provide a meaningful improvement in cancer care,” said
For more information on the trial, please visit: http://www.clinicaltrials.gov/ct2/show/NCT01778803.
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About
Forward-looking statements:
This press release includes forward-looking statements about the
Company’s strategy, future plans and prospects, including statements
regarding the development of the Company’s compounds, including VS-6063,
VS-4718 and VS-5584, and the Company’s FAK, PI3K/mTOR and diagnostic
programs generally, the timeline for clinical development and regulatory
approval of the Company’s compounds and the structure of the Company’s
planned clinical trials. The words “anticipate,” “appear,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,”
“target,” “potential,” “will,” “would,” “could,” “should,” “continue,”
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain these
identifying words. Each forward-looking statement is subject to risks
and uncertainties that could cause actual results to differ materially
from those expressed or implied in such statement. Applicable risks and
uncertainties include the risks that the preclinical testing of the
Company’s compounds may not be predictive of the success of later
clinical trials, that the Company will be unable to successfully
complete the clinical development of its compounds, including VS-6063,
VS-4718 and VS-5584, that the development of the Company’s compounds
will take longer or cost more than planned, and that the Company’s
compounds will not receive regulatory approval or become commercially
successful products. Other risks and uncertainties include those
identified under the heading “Risk Factors” in the Company’s Annual
Report on Form 10-K for the year ended
Source:
Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com