NEW YORK, Aug. 15, 2016 /PRNewswire/ -- BeyondSpring Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, announced today that the first patient in the global Phase 3 trial of its lead immuno-oncology asset Plinabulin, was enrolled in China on August 12, 2016 at the Shanghai Chest Hospital in Shanghai by Dr. Baohui Han, the principal investigator at this site. Shanghai Chest Hospital has extensive experience conducting global Phase 3 trials in non-small cell lung cancer (NSCLC) and has participated in trials with drugs approved by the U.S. FDA.
Plinabulin is in a global Phase 3 trial in 2nd and 3rd line non-small cell lung cancer (NSCLC) in combination with docetaxel. This trial is being conducted in the U.S. and China by the prominent global contract research organization ICON, and is expected to enroll 440 patients in China, and 110 patients in the U.S. and other western countries.
"Our mission is to develop Plinabulin as an innovative and cost-effective oncology therapeutic to aid patients suffering from non-small cell lung cancer (NSCLC), which accounts for approximately 85 percent of all lung cancer cases," said Dr. Lan Huang, BeyondSpring's co-founder, chairman and CEO. "One third of lung cancer patients globally reside in China and the announcement of our first enrolled patient will open the doors to rapid enrollment for this global study."
"BeyondSpring is partnering with ICON to ensure that the quality of our clinical data from China meets U.S. FDA standards," stated Dr. Ramon Mohanlal, M.D., Ph.D., Chief Medical Officer of BeyondSpring. "Dr. Yan Sun, a renowned medical Oncologist from the Chinese Academy of Medical Sciences' cancer hospital, is the primary investigator for the global Phase 3 trial in China. The recent U.S. FDA approval of an innovative lung cancer drug Afatinib which used 72 percent of patients from China for its pivotal Phase 3 trial, also validates our combined China/U.S. clinical strategy to enable market authorization in the U.S."
About BeyondSpring Pharmaceuticals
BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring has advanced its lead asset, Plinabulin, into a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer. The Company is also planning a Phase 3 clinical trial for Plinabulin in the prevention of docetaxel-induced Neutropenia. BeyondSpring's experienced management team brought a combined 30+ drugs to market.
Plinabulin is an innovative small molecule agent that has multiple mechanism of action, with immune enhancing mechanism, tumor vasculature targeting, and activating JNK pathway to induce cancer cell apoptosis.
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SOURCE BeyondSpring Pharmaceuticals