|[September 10, 2013]
Veristat to Assist on Adaptive Enrichment Trial for Verastem's Defactinib in Mesothelioma
HOLLISTON, Mass. --(Business Wire)--
Veristat, LLC., a leading, Boston-based clinical research organization
today announced its advisory role on the implementation of an adaptive
enrichment trial design for Verastem, Inc. (NASDAQ: VSTM). The enhanced
design aims to optimize the current trial of defactinib, a novel, small
molecule inhibitor of focal adhesion kinase (FAK) in patients with
malignant pleural mesothelioma.
"We have identified a biomarker in mesothelioma that may predict
increased sensitivity to defactinib," said Dr. Joanna Horobin, Chief
Medical Officer at Verastem. "We felt strongly that the application of
an enrichment design would help us to accelerate the program to a
potential regulatory decision. We are excited to have Veristat's
experience in enrichment trial design and execution supporting this
Veristat's input on the overall trial design, as well as the adaptive
enrichment design architecture and planned analyses will help facilitate
decisions required at key development intersections of the program.
"The Verastem clinical development team hs taken a dynamic approach to
the design of this study," commented Dr. John Balser, President at
Veristat. "Our team at Veristat will be assisting them with the
statistical and operational challenges inherent in the adaptive
enrichment design architecture. Our goal is to produce a trial that will
quickly and cost effectively yield the highest likelihood of success for
their target patient population."
Bringing 20 years of experience to its clients, Veristat is a clinical
research organization (CRO) that supports pharmaceutical, biotechnology
and medical device companies through every phase of the clinical trial
process, as well as the preparation of integrated summary documents and
submission-ready CDISC data for regulatory filings. Visit www.veristat.com.
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.
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