|August 26, 2015|
|Verastem Issues Statement Regarding WCLC Presentations|
“While updated results from the Phase 2 study of VS-6063 in KRAS mutant
non-small cell lung cancer are under embargo until WCLC,
“The totality of safety and efficacy data seen to date with VS-6063
across multiple clinical trials, multiple tumor types and stages of
treatment is promising. In addition, in the Company’s
registration-directed COMMAND trial in mesothelioma, an independent data
safety monitoring board has met and reviewed study data, including
adverse events, three times and recommended no changes to study
protocol. There have been over 300 patients treated to date with
VS-6063, including patients on drug for more than one year.
VS-6063 (defactinib) is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a “Window of Opportunity” study in patients with mesothelioma prior to surgery, a Phase 1/1b study in combination with paclitaxel in patients with ovarian cancer, a trial in patients with KRAS-mutated non-small cell lung cancer and a trial evaluating the combination of VS-6063 and VS-5584 in patients with relapsed mesothelioma. VS-6063 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.
This press release includes forward-looking statements about the
Company’s strategy, future plans and prospects, including statements
regarding the development, activity and clinical potential of the
Company’s product candidate, VS-6063, and the Company’s FAK program
generally and the structure of our planned or pending 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 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 our
product candidates, including VS-6063, will cause unexpected safety
events, that the Company will be unable to successfully initiate or
complete the clinical development of its product candidates, 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
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