TESARO, Inc. (Nasdaq: TSRO) announced today that the first clinical trial of its proprietary Anaplastic Lymphoma Kinase (ALK) inhibitor, TSR-011, has commenced with the dosing of the first patient at the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).
TSR-011 is an orally available ALK inhibitor (targeted anti-cancer agent) that will be studied in patients, including non-small cell lung cancer (NSCLC) patients, with ALK+ tumors. TESARO plans to expand the Phase 1/2 clinical trial of TSR-011 to multiple clinical trial sites in the U.S. and Europe.
"TSR-011 has the profile of a promising targeted anti-cancer agent and we are enthusiastic about the opportunity to investigate its potential in patients," said Dr. Glen Weiss, Director of Thoracic Oncology at the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and Clinical Associate Professor at TGen.
Following identification of the maximum tolerated dose of TSR-011 in patients with advanced cancer during the dose escalation phase of the trial, TESARO plans to evaluate TSR-011 in three parallel cohorts of patients in the phase 2 portion: those with ALK+ NSCLC who have not been previously treated with ALK inhibitors, those with NSCLC who have progressed during treatment with other ALK inhibitors, and those with other tumor types expressing ALK.
"We are very pleased to have progressed TSR-011 into a human clinical trial and look forward to identifying a dose that may be utilized in the expansion phase of the study which will assess both the safety and efficacy of the compound," said Mary Lynne Hedley, Ph.D., TESARO's President and Chief Scientific Officer. "ALK is a key driver of subsets of NSCLC, and may also contribute to the growth of neuroblastoma, lymphoma and other cancers. In order to maximize the commercial potential of TSR-011, we plan to study TSR-011 in multiple treatment and tumor settings."
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