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Verastem Initiates Clinical Trial of Dual mTOR/PI3K Inhibitor
Phase 1 dose escalation and schedule finding trial in solid tumors and lymphomas
“Initiation of the clinical development of VS-5584 is an important
milestone for Verastem,” said Dr.
“Recent research by my laboratory and others has demonstrated that the
dual inhibition of both PI3K and mTOR may be necessary to reduce the
observed resistance to PI3K-selective inhibitors in solid tumors,” said
José Baselga, M.D., Ph.D., Verastem Senior Medical Advisor and
Physician-in-Chief at
The Phase 1 open-label, dose escalation and schedule finding study is designed to assess the safety, pharmacokinetics, pharmacodynamics and initial clinical activity of single agent VS-5584. VS-5584 is an orally-available compound. The study will enroll up to 62 patients.
“2013 has been an important year of clinical execution for Verastem,”
said
About VS-5584
VS-5584 is an oral compound that potently and selectively inhibits the class 1 PI3K isoforms, mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in multiple tumor models. VS-5584 is currently being evaluated in a Phase 1 dose escalation and schedule finding trial in patients with advanced solid tumors or lymphomas.
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-5584
and the Company’s mTOR/PI3K program, the timeline for clinical
development and regulatory approval of the Company’s compounds, the
expected timing for the reporting of data from ongoing trials, and the
structure of the Company’s planned or pending clinical trials, including
the Phase 1 trial of VS-5584. 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 and preliminary 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 the Company will be unable to successfully
complete the clinical development of its compounds, including 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