Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today announced that the Company has stopped enrollment in the Phase 2 registration-directed, double-blind, placebo-controlled study (COMMAND) of VS-6063 for patients with mesothelioma. The decision to stop enrollment for futility followed a Data Safety Monitoring Board (DSMB) review of a pre-planned interim analysis. The results of the analysis demonstrated that VS-6063 had a generally well tolerated safety profile but that there was not a sufficient level of efficacy to warrant continuation of the study.
“Malignant pleural mesothelioma is among the most aggressive and lethal cancers with only one approved therapy,” said Lou Vaickus, MD FACP, Interim Chief Medical Officer. “With the aggressiveness of this disease, the use of single agent VS-6063 as a maintenance treatment following chemotherapy where all patients had residual disease was not sufficient. There remains a significant unmet medical need for new treatment options for patients suffering from this very complex, difficult-to-treat cancer.”
“We have stopped further enrollment and initiated an orderly wind-down of the COMMAND study,” said Robert Forrester, Verastem President and Chief Executive Officer. “We are disappointed with the COMMAND outcome, but we are deeply grateful for the support and commitment from the patients participating in the study, their families, and the study investigators. Based on these results, we will reevaluate our clinical priorities and direct our resources toward further development of VS-6063, VS-4718, and VS-5584.”
As of the end of Q2 2015, Verastem had $132.1M in cash and cash equivalents.
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Date: | 9/28/2015 | ||
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About Verastem, Inc.
Verastem, Inc. (NASDAQ:VSTM) is
discovering and developing drugs to treat cancer by the targeted killing
of cancer stem cells. Cancer stem cells are an underlying cause of tumor
recurrence and metastasis. Verastem is developing small molecule
inhibitors of signaling pathways that are critical to cancer stem cell
survival and proliferation: FAK and PI3K/mTOR. For more information,
please visit www.verastem.com.
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 product candidates, including VS-6063. 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 product candidates and preliminary
or interim data from clinical trials may not be predictive of the
results or success of ongoing or later clinical trials, that data may
not be available when we expect it to be, that enrollment of clinical
trials may take longer than expected, that the Company will be unable to
successfully complete the clinical development of its product
candidates, including VS-6063, that the development of the Company’s
product candidates will take longer or cost more than planned, and that
the Company’s product candidates 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 December 31,
2014 and in any subsequent SEC filings. The forward-looking statements
contained in this press release reflect the Company’s current views with
respect to future events, and the Company does not undertake and
specifically disclaims any obligation to update any forward-looking
statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150928005465/en/
Contacts:
Brian Sullivan, 781-292-4214
bsullivan@verastem.com