BeyondSpring's Global Phase III Non-Small Cell Lung Cancer Clinical Trial for Plinabulin Launches in China
NEW YORK, June 28, 2016 /PRNewswire/ -- BeyondSpring Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, including a Phase III immuno-oncology compound and strong pipeline in collaboration with the Fred Hutchinson Cancer Research Center, announced today that its global Phase III non-small cell lung cancer (NSCLC) clinical trial for BeyondSpring's innovative lead asset, Plinabulin, has just launched in China.
The start of the trial follows an influential investigator conference in Beijing, which was held on May 28, 2016, with over 120 representatives and experts from hospitals, clinical research centers and the like in attendance.
"The success of this meeting is a strong indication for the beginning of BeyondSpring's global multi-center Phase III clinical trial for Plinabulin," said Dr. Lan Huang, BeyondSpring's co-founder, chairman and CEO. "Our goal with Plinabulin is to implement a highly innovative, yet cost-effective oncology therapeutic to assist patients who have high unmet medical needs. Plinabulin's product profile is especially attractive, because it can become an efficient, safe and convenient alternative to G-CSF, including its biosimilars."
Plinabulin is a small multi-target molecule that targets tumor vasculature and improves immune systems with anti-cancer characteristics. Plinabulin's first indication is to treat NSCLC with Docetaxel, which was approved by the FDA for Phase III international multi-center clinical studies in July 2015.
Seventy-five percent of the patients come from sites in China. The Chinese FDA approved the Chinese part of the clinical trial in December 2015, embarking the global initiation of the Phase III international clinical trial in the U.S, China and Australia. The trial aims to enroll 550 patients in total, with 440 from China and 110 from the U.S. and Australia.
"There are two ways to conquer cancer – the first is to develop new drugs, and the second is to prevent tumors," said Dr. Yan Sun of the Chinese Academy of Medical Sciences' cancer hospital, primary investigator for the Chinese part of the clinical trial. "In China, the incidence rates have plateaued and will decline shortly after. As an innovative drug with full proprietary intellectual property rights, Plinabulin brings hope to cancer patients all over the world, as our initial findings are nothing short of both exciting and encouraging."
"The Chinese part of the clinical study may have a tremendous impact on the destiny of Plinabulin as a new drug since a large proportion of the clinical trial is conducted in China," added Associate Dean Yuankai Shi of the Chinese Academy of Medical Sciences' cancer hospital, a co-primary investigator of the regional trial study. "It is more imperative than ever that all procedures align with international standards in an organized fashion."
Following the investigator meeting, in June 2016, 19 clinical sites in China had passed IRB approval, and two sites are now ready to enroll patients.
About BeyondSpring PharmaceuticalsBeyondSpring is a global clinical stage biopharmaceutical company developing innovative cancer therapies targeting immuno-oncology and tumor vascularization. BeyondSpring has advanced its lead asset, Plinabulin, into a Phase III clinical trial as a direct anticancer agent in non-small cell lung cancer. The Company is also planning a Phase III clinical trial for Plinabulin in the prevention of Docetaxel-induced Neutropenia. BeyondSpring's management team brought a combined 30+ drugs to market. The Company's immuno-oncology pipeline is robust, including a collaboration agreement with the Fred Hutchinson Cancer Research Center.
About PlinabulinPlinabulin is a small molecule agent that is administered by IV infusion (30-minute infusion) and is administered 60 minutes after completion of Docetaxel infusion, on the same day of Docetaxel infusion.
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SOURCE BeyondSpring Pharmaceuticals