Press Release
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Verastem Doses First Patient in Phase 1 Clinical Trial Evaluating VS-5584 in Combination with VS-6063 in Mesothelioma
-Study Builds Upon Encouraging Clinical Progress for Both VS-6063 and VS-5584-
-Synergistic Activity of VS-6063 and VS-5584 Demonstrated in Preclinical Models of Mesothelioma-
The Phase 1 open-label, dose escalation and schedule finding study is
designed to assess safety, pharmacokinetics, pharmacodynamics and
initial observations of clinical activity. The study is expected to
enroll up to 56 patients at clinical sites in the
“We are very pleased to initiate the first ever Phase 1 trial combining
a dual mTORC1/2 and PI3K inhibitor (VS-5584) with a FAK inhibitor
(VS-6063),” said
“Mesothelioma is a devastating disease and
VS-5584 is currently in a Phase 1 study in advanced solid tumors where the compound has been generally well tolerated and preliminary activity has been observed, including in mesothelioma. Some patients have been on study for over 6 months and the maximum tolerated dose of VS-5584 has not been reached.
The combination clinical trial is supported by preclinical work demonstrating the synergistic activity of VS‐6063 and VS‐5584 in mesothelioma models in vitro and in vivo. In this preclinical research, the combination of VS‐6063 and VS‐5584 displayed synergistic reduction in cell viability based on multiple combination analysis models. When tested in vivo for reduction of mesothelioma tumor growth, VS‐6063 and VS‐5584 were each active as single agents and demonstrated synergistic antitumor efficacy when used in combination.
About Mesothelioma
Mesothelioma is an aggressive form of cancer that occurs in the
mesothelium, the thin layer of tissue that covers the lungs and other
organs. Mesothelioma is associated with exposure to asbestos in most
cases. According to the
About VS-6063
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 by
About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and
highly selective activity against class 1 PI3K enzymes and dual
inhibitory actions against mTORC1 and mTORC2. In preclinical studies,
VS-5584 has been shown to reduce the percentage of cancer stem cells and
induce tumor regression in chemotherapy-resistant models.
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 and activity of the Company’s product
candidates, VS-6063 and VS-5584, and the Company’s FAK and PI3K/mTOR
programs generally, the timeline for clinical development and regulatory
approval of the Company’s product candidates, and the structure of the
Company’s 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, including the
combination trial of VS-6063 and VS-5584, that data may not be available
when we expect it to be, that enrollment will take longer than expected,
that our product candidates will cause unexpected safety events, that
the Company will be unable to successfully 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 ended
Source:
Verastem, Inc.
Brian Sullivan, 781-292-4214
bsullivan@verastem.com