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Verastem Receives Orphan Medicinal Product Designation from the European Commission for VS-6063 in Mesothelioma
“We are pleased that the EMA recognizes the significant unmet medical
need in mesothelioma,” said
VS-6063 is an orally-available, small molecule inhibitor of focal adhesion kinase (FAK). Research on the FAK signaling pathway has revealed a critical role for cancer stem cell survival and disease progression.
“Mesothelioma is a devastating disease with limited treatment options,”
said Dr.
A biomarker test is being developed in conjunction with LabCorp (NYSE:
LH) to identify a subgroup of mesothelioma patients low in a marker
called Merlin. Approximately 40-50% of mesothelioma patients lack
Merlin. Studies by
“We are in discussions with regulatory agencies worldwide,” said
Under EMA guidelines, Orphan Medicinal Product Designation provides up
to 10 years of potential market exclusivity if the product candidate is
approved for marketing in the
In addition to the upcoming mesothelioma study, VS-6063 is currently being evaluated in a Phase 1/1b trial in combination with paclitaxel in patients with ovarian cancer.
About Verastem, Inc.
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 including the impact of and any
potential benefits from Orphan Medicinal Product Designation, and the
structure of the Company’s planned clinical trials and estimates of the
Company’s ability to fund operations. 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