– Well Tolerated; Meets Study Objectives –
– Results Facilitate Potential Parallel Development of VS-6063
(defactinib) in Japan –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 5, 2014--
Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing
drugs to treat cancer by the targeted killing of cancer stem cells,
today presented preliminary data from an ongoing First-in-Asia Phase 1
trial of VS-6063 in Japanese patients with advanced solid tumors,
including one patient with mesothelioma. The Phase 1 study assessed the
safety and pharmacokinetics of single agent VS-6063.
“We are encouraged that the safety and pharmacokinetic profile observed
in Japanese patients in this Phase 1 study is consistent with that seen
in the US Phase 1 study,” said Dr. Joanna Horobin, Verastem Chief
Medical Officer. “With these data in hand, we are speaking with the
Japanese regulatory authorities about the potential for opening COMMAND
trial sites in Japan later this year.”
Verastem’s ongoing COMMAND trial is a randomized, double-blind, placebo
controlled registration-directed study which is evaluating VS-6063 in
patients with mesothelioma and is currently accruing patients in 8
countries.
The Japanese Phase 1 is an open-label, dose-escalation study that
enrolled nine subjects who received single-agent VS-6063 (200, 400 or
600mg; n=3 in each dose cohort) BID. The study results demonstrated that
VS-6063 was well tolerated at all dose levels. There were no serious
adverse events or evidence of dose-limiting toxicity. Pharmacokinetic
results from the recommended Phase 2 dose of 400mg BID were consistent
with previously reported data in non-Japanese subjects. These safety and
pharmacokinetic results support advancing the VS-6063 development
program in Japanese patients.
“We have now completed full enrollment and VS-6063 was well tolerated at
each dose level,” said Toshio Shimizu, M.D., Ph.D., Assistant Professor,
Phase 1 Clinical Trials Program, Department of Medical Oncology, Kinki
University Faculty of Medicine and Principal Investigator of the study.
“The study was open to patients with all solid tumors and one of the
patients has mesothelioma. This patient is enrolled in the 400mg BID
dose cohort and is responding well to treatment, continues on trial and
is currently in cycle 7 of treatment. At this point their disease
remains stable and we have seen an improvement in clinical symptoms.
These data are encouraging and we hope to continue development of
VS-6063 in Japan in parallel with the United States and Europe.”
The details of the presentation and a downloadable link to the
presentation are as follows:
Conference: 12th International Congress on Targeted Anticancer
Therapies
Date: March 5, 2014
Location: Capitol
Hilton in Washington, D.C.
Abstract Title: Addressing the
Drug Lag in Japan: A Phase 1 Study of Defactinib in Japanese Subjects to
Facilitate Multiregional Clinical Trials
Abstract Code: P6.1
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
Robert Weinberg, Ph.D., scientific cofounder and chair of Verastem’s
Scientific Advisory Board, and Verastem has demonstrated that the FAK
pathway 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 Phase 1/1b study in combination with paclitaxel for patients with
ovarian cancer, a Phase 1 study in Japan in patients with advanced solid
tumors and a Phase 2 trial in patients with Kras-mutated non-small cell
lung cancer. VS-6063 has been granted orphan drug designation in the
U.S. and E.U. for use in mesothelioma.
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, PI3K/mTOR and Wnt. 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 compounds, including VS-6063,
or defactinib, and the Company’s FAK inhibition program, the timeline
for clinical development and regulatory approval of the Company’s
compounds, including the potential for opening COMMAND trial sites in
Japan, the expected timing for the reporting of data from ongoing
trials, and the structure of the Company’s planned or pending clinical
trials, and potential indications for clinical development. 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 Japanese regulatory
authorities will not approve the initiation of the COMMAND trial, that
the Company will be unable to successfully complete the clinical
development of its compounds, including VS-6063, 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 December 31,
2012 and in any subsequent SEC filings. The forward-looking statements
contained in this presentation 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.
Source: Verastem
Verastem, Inc.
Brian Sullivan, 617-252-9314
bsullivan@verastem.com