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Veristat to Assist on Adaptive Enrichment Trial for Verastem’s Defactinib in Mesothelioma

Veristat, LLC., a leading, Boston-based clinical research organization, recently 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 trial.”

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 has taken a dynamic approach to the design of this study,” commented Dr. John Balser, president and chief science officer 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.”

Source: Veristat

Study Says New Biomarker May Predict Mesothelioma Survival, According to Surviving Mesothelioma

A team of researchers at Australia’s University of New South Wales say MUC1, a glycoprotein found on the outer surface of epithelial cells, is overexpressed in peritoneal mesothelioma. MUC1 is a mucin, a type of protein that helps protect the body against infection by binding with pathogens in the extracellular space and preventing them from entering cells.

Although MUC1 overexpression can predict poor survival in most cancers, and is often used to help diagnose mesothelioma, the Australian study is the first to measure its prognostic significance in mesothelioma, a rare cancer brought on by asbestos exposure. Mesothelioma most often occurs on the membrane that lines the lungs but peritoneal mesothelioma affects the lining of the abdomen. It accounts for about 25 to 30 percent of mesothelioma cases and, like all types of mesothelioma, is usually deadly.

Of the 42 peritoneal mesothelioma patients in the new study, 38 showed overexpression of MUC1. The significance of that overexpression was measured using the Kaplan-Meier method. Mesothelioma patients with a MUC1 level (based on immunohistochemical tests) between 5 and 8 had the lowest survival in all subtypes of tumors. Of the different variables tested – including tumor subtype, patient gender, peritoneal cancer index, and age at diagnosis – only a high MUC1 level and being over 60 years old at the time of diagnosis were consistently associated with poor outcomes.

Writing on their findings in the International Journal of Biological Markers, the authors conclude, “MUC1 evaluation by immunohistochemistry may serve as a useful prognostic tool in malignant peritoneal mesothelioma, but may need further confirmation in larger patients’ cohort.” Earlier this year, the same team of researchers determined that high expression of BCL2, a protein that helps regulate cell death (apoptosis), is associated with a good prognosis for patients with peritoneal mesothelioma.

In clinical practice, biomarkers are often used to help plan a treatment strategy for mesothelioma and other hard-to-treat cancers.

The original study appears in a recent issue of the International Journal of Biological Markers. (Pillai, K, et al, “MUC1 has prognostic significance in malignant peritoneal mesothelioma”, July 4, 2013, International Journal of Biological Markers, Epub head of print. http://www.ncbi.nlm.nih.gov/pubmed/23828409)

Study: MUC1 has prognostic significance in malignant peritoneal mesothelioma [International Journal of Biological Markers]

Source: PR Web

Verastem Enters Biomarker Agreement with LabCorp for Cancer Stem Cell Agent Companion Diagnostic

Verastem, Inc., (NASDAQ: VSTM) a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, entered an agreement with Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) to validate biomarkers for its lead focal adhesion kinase (FAK) inhibitor VS-6063 in the development of an applicable companion diagnostic.

Mesothelioma Drug Slows Disease Progression in Patients with an Inactive NF2 Gene

Preliminary findings from the first trial of a new drug for patients with mesothelioma show that it has some success in preventing the spread of the deadly disease in patients lacking an active tumour suppressor gene called NF2. The study is presented at the 24th EORTC-NCI-AACR [1] Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland, today (Friday) [2].

High Levels of Blood-Based Protein Specific to Mesothelioma

Researchers at NYU School of Medicine have discovered the protein product of a little-known gene may one day prove useful in identifying and monitoring the development of mesothelioma in early stages, when aggressive treatment can have an impact on the progression of disease and patient prognosis.