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Verastem Begins New Phase 1 Clinical Trial

Verastem, an innovative leader in the development and discovery of new drugs that target cancer stem cells, dosed the first patient in a phase 1 clinical trial that is testing the effectiveness and safety of combining two of its drugs — VS-5584 (a dual mTORC1/2 and PI3K inhibitor), with VS-6063 (a focal adhesion kinase inhibitor). The treatment is being given to patients who have mesothelioma that had been in remission and have relapsed.

Phase 1 trials are clinical trials that represent the very first step in a long process that drugs take before receiving approval from the Food and Drug Administration and eventually reaching the market. The first step determines whether the drug is save, and records initial observations about pharmacokinetics, clinical activity and pharmacodynamics. The Verastem study that just began will eventually involve almost five dozen patients, located in the United States and the United Kingdom.

Dr. Udai Banerji, MD, PhD, FRCP, Reader in Molecular Cancer Pharmacology and Honorary Consultant in Medical Oncology at The Royal Marsden Hospital and The Institute of Cancer Research London, said, “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). This study builds on robust synergy data from pre-clinical mesothelioma models presented by Verastem at the recent iMiG meeting. The trial is enrolling patients with relapsed mesothelioma: a patient population in dire need of new treatment options.”

Echoing his ccomments, Dr. Joanna Horobin, Chief Medical Officer of Verastem said, “Mesothelioma is a devastating disease and Verastem is committed to the development of new treatment options. This is the third study we have initiated with VS-6063 in patients with mesothelioma. We are very pleased with the progress of the multinational COMMAND study evaluating a VS-60603 as a switch maintenance therapy following frontline chemotherapy in patients with malignant pleural mesothelioma. As reported in October at the 2014 iMiG, we are encouraged by the biomarker response and intriguing tumor shrinkage observed after twelve days of single agent VS-6063 administration in patients with untreated mesothelioma, prior to planned surgery. In this new study of VS-6063 in combination with VS-5584, building on the synergy seen in pre-clinical models, we hope to extend the potential benefit to patients with mesothelioma that has relapsed following initial therapy.”

Terri Oppenheimer

Terri Oppenheimer is an independent writer, editor and proofreader. She graduated from the College of William and Mary with a degree in English. Her dreams of a writing career were diverted by a need to pay her bills. She spent a few years providing copy for a major retailer, then landed a lucrative career in advertising sales. With college bills for all three of her kids paid, she left corporate America for a return to her original goal of writing. She specializes in providing content for websites and finds tremendous enjoyment in the things she learns while doing her research. Her specific areas of interest include health and fitness, medical research, and the law.

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