NEW YORK, Dec. 9, 2014 (GLOBE NEWSWIRE) -- BeyondSpring Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, announced that leading thoracic oncologist in China Dr. Yan Sun has been named the principal investigator (PI) for the China component of the Company's Phase 3 pivotal trial of lead drug candidate, Plinabulin. Dr. Sun is the founding member of the Chinese Society of Clinical Oncology (CSCO) and served as Chairman from 1997 to 2013.
The Plinabulin global trial will examine the safety and efficacy of the drug in patients with non-small cell lung cancer (NSCLC) and was designed in consultation with regulatory authorities in both the United States and China where all patients will be enrolled.
The initiation of the Phase 3 trial – currently scheduled for the first quarter of 2015 – follows the presentation of positive Phase 2 data that demonstrated, in a subset population targeted by Plinabulin mechanism of action (those with large lung cancer lesions), a median overall survival of 11.5 months for patients receiving Plinabulin and docetaxel in combination compared to 7.8 months for patients on docetaxel alone. The study results were presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting, by principal investigator Dr. Rebecca Heist, MD, MPH of Massachusetts General Hospital, whose site enrolled approximately 25 percent of the study's patients.
In China, the results were presented by Dr. Lan Huang, co-founder and CEO of BeyondSpring, during two major medical conferences this year: an oral presentation at the 8th Chinese Symposium on Medical Oncology (CSMO) held July 2-6, 2014 in Beijing, China and at a company-sponsored satellite meeting with lead Chinese investigators during the 17th CSCO Annual Meeting held September 17-20, 2014 in Xiamen, China.
During the satellite meeting at CSCO, the BeyondSpring team met with 23 clinical investigators from prominent cancer centers in China who are involved in initiating the global Phase 3 trial at the China-based sites. The oncologists – all key opinion leaders – named Dr. Yan Sun as the trial's PI. Dr. Sun is a member of the China National Academy of Science and is a lead cancer specialist at the National Academy of Science Tumor Hospital in Beijing, the largest Cancer hospital in China.
"Naming Dr. Sun as the principal investigator for the global Phase 3 trial of the Chinese arm of our cross-border trial is a crucial step forward as we proceed with our plans to initiate this pivotal trial of Plinabulin," said Lan Huang, Ph.D., Chief Executive Officer of BeyondSpring Pharmaceuticals. "Dr. Sun's training at MD Anderson Cancer Center in the United States as well as his experience participating in global Phase 3 trials of novel NSCLC drugs, including Avastin®, Tarceva®, Iressa™, Alimta®, and Gilotrif® in China, will ensure that clinical data collected in China will meet U.S. GCP (Good Clinical Practice) standards. His appointment, along with the active participation of top Chinese clinical investigators, will facilitate initiation of the trial with swift patient enrollment and the collection and maintenance of quality data."
Plinabulin is an anti-cancer agent with a unique mechanism of action. It is a multi-target agent that has been shown to exhibit anti-tumor activity through anti-angiogenesis, obliteration of existing tumor vasculature and induction of tumor cell apoptosis via the JNK pathway.
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer deaths in the world.i In 2012, there were approximately 1.8 million new cases and 1.6 million estimated deaths worldwide.i There are two main types of lung cancer: Small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), which is the more common form, accounting for approximately 85 percent of all lung cancers.ii
About BeyondSpring Pharmaceuticals
BeyondSpring Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSpring is focused on the advancement and commercialization of Plinabulin, a novel, Phase 3-ready 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 lead product candidate, Plinabulin. For more information, visit www.beyondspringpharma.com.
i American Lung Association. "Lung Cancer Fact Sheet." Available at: http://www.lung.org/lung-disease/lung-cancer/resources/facts-figures/lung-cancer-fact-sheet.html
ii American Cancer Society. "Non-small Cell Lung Cancer." Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf