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Verastem Initiates Phase 1/1b Clinical Trial of VS-6063 Plus Paclitaxel for Patients with Ovarian Cancer
--VS-6063 Kills Cancer Stem Cells through Potent Inhibition of Focal Adhesion Kinase--
VS-6063 is a potent inhibitor of focal adhesion kinase (FAK) and has demonstrated signs of clinical activity in ovarian cancer in a single agent, Phase 1 clinical trial.
“In the Phase 1 study we demonstrated that VS-6063 as a single agent was
generally well tolerated, giving us optimism that this novel agent can
be combined with the widely used drug paclitaxel," said Principal
Investigator Howard “Skip” Burris, III, M.D., Chief Medical Officer and
Executive Director, Drug Development Program,
“We believe that cancer stem cells are ultimately responsible for
disease progression with ovarian and other cancers,” said Dr.
The Phase 1b trial is an open-label, multicenter, dose-escalation trial of VS-6063 in combination with paclitaxel. The endpoints of the study are safety, tolerability and efficacy as determined by Response Evaluation Criteria in Solid Tumors (RECIST) and proprietary cancer stem cell biomarkers. The study will enroll up to 30 patients with ovarian cancer at three U.S. locations.
“Our unique understanding of cancer stem cell biology, coupled with our
focus on execution in research and development, has allowed us to build
the leading portfolio of FAK inhibitors,” said
For more information on the trial, please visit: http://clinicaltrials.gov/ct2/show/NCT01778803.
About
About VS-6063
VS-6063 is an oral small molecule inhibitor of focal adhesion kinase (FAK) which is a critical pathway for cancer stem cells. VS-6063 was well-tolerated and demonstrated signs of clinical activity in a Phase 1 study in advanced solid tumors. VS-6063 is currently in a Phase 1/1b study in patients with advanced ovarian cancer, where VS-6063 is being tested in combination with paclitaxel. VS-6063 is anticipated to enter a potentially pivotal study in mesothelioma midyear 2013.
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,
and the Company’s FAK 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, 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.
Investor contact:
Brian Sullivan,
617-252-9314
bsullivan@verastem.com
or
Media
contact:
Kari Watson, 781-235-3060
kwatson@macbiocom.com