BeyondSpring Pharmaceuticals Granted CTA by CFDA to Initiate China Arm of Global Phase III Trial of Lead Asset Plinabulin
NEW YORK, Dec. 21, 2015 (GLOBE NEWSWIRE) — BeyondSpring Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the China Food and Drug Administration (“CFDA”) has given a CTA (Clinical Trial Authorization) for the initiation of the China arm of the global Phase III clinical trial of the Company’s lead asset, Plinabulin, for the treatment of non-small cell lung cancer (NSCLC) in combination with docetaxel. This 550-patient global Phase III trial will be conducted in the United States, China, Australia and New Zealand, and was authorized by the U.S. Food and Drug Administration (“FDA”) in July 2015.
Lan Huang, Ph.D., co-founder and Chief Executive Officer of BeyondSpring commented, “China is a fast-growing market of strategic interest to BeyondSpring. We are pleased to have been granted a CTA by CFDA to initiate the Plinabulin global Phase III pivotal trial in China. We are grateful to Dr. Yan Sun, one of China’s oncology pioneers and co-founder and former Chairman of the Chinese Society of Clinical Oncology (CSCO), for agreeing to lead the Phase III study in China and serve as the Principal Investigator in China. ICON China will serve as our CRO in China to provide clinical research services and ensure compliance with US GCP. Patient treatment protocols in China and the United States are the same as they both adhere to identical National Comprehensive Cancer Network (NCCN) guidelines for lung cancer treatment. We are confident that with Dr. Sun’s leadership and the operational support of ICON China that the Chinese arm of the global Phase III trial will generate high-quality patient data to support the Plinabulin NDA submission.”“Plinabulin has a dual mechanism of action; it has potent vascular disruptive effects and potent immune-enhancing effects. In Phase II trials with advanced NSCLC, Plinabulin in combination with docetaxel has demonstrated superior efficacy, in particular in large lung lesions, and safety over docetaxel alone, such as significantly reduced neutropenia and asthenia rates,” Ramon Mohanlal, M.D., Ph.D., Chief Medical Officer of BeyondSpring commented. “The recently published data with checkpoint inhibitors demonstrated that docetaxel is slightly more effective than nivolumab in PD-L1 negative non-squamous NSCLC. Furthermore, docetaxel had better OS benefit in EGFR wild type NSCLC patients compared with Tarceva in a recent study. However, many oncologists are concerned about the safety profile of docetaxel. The Plinabulin/docetaxel combination not only improved efficacy, but also mitigated known neutropenia related safety concerns with docetaxel, and therefore this combination may provide a good treatment option in patients for whom docetaxel is considered.”The Phase III clinical trial aims to evaluate the regimen of Plinabulin in combination with docetaxel (30 mg/m2 and 75 mg/m2 respectively) compared to docetaxel (75 mg/m2) monotherapy in adult patients with advanced NSCLC with at least one lung lesion size greater than three centimeters (3 cm). The primary endpoint is overall survival, with secondary endpoints including patient-reported-outcomes, safety, progression-free survival (PFS), response rate (RR), and duration of response (DOR).About BeyondSpring PharmaceuticalsBeyondSpring Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of a number of innovative immuno-oncology cancer therapies. BeyondSpring is focused on the advancement and commercialization of its lead asset Plinabulin, a novel, Phase III cancer therapeutic initially targeting non-small-cell lung cancer (NSCLC). Led by an expert management team consisting of pharmaceutical industry veterans from the U.S. and China, the Company is well positioned to further advance the lead product candidate, Plinabulin. For more information, visit www.beyondspringpharma.com.Contact
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