NEW YORK, Oct. 26, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has enrolled its first patient in China in the global Phase 2/3 clinical trial of its lead immuno-oncology asset, Plinabulin, for the prevention of chemotherapy-induced neutropenia (CIN) on October 25, 2017. The enrollment took place at the Harbin Medical University Cancer Hospital in Harbin, China, led by Co-Principal Investigator Dr. Qingyuan Zhang. Dr. Zhang, a well-respected clinician, has frequently been invited to give lectures at MD Anderson Cancer Center.
Neutropenia, a common side effect of chemotherapy in cancer patients, is the destruction of a type of white blood cell (neutrophil) that is a key component of the innate immune system. Neutrophils are a patient’s first line of defense against infections, and patients with severe (grade 4) neutropenia (an abnormally low concentration of Neutrophils in the blood) are more susceptible to severe bacterial, viral and fungal infections and sepsis, which require hospitalization and have high mortality risk.
“Having achieved this key milestone with the enrollment of our first patient in China in this study, BeyondSpring is well on track to meet our enrollment goals due to the large number of patients in China who are eligible for these trials,” said Dr. Lan Huang, BeyondSpring CEO. “Additionally, BeyondSpring’s unique U.S. / China integration model enables us to tap into China’s vast resources, supporting our efforts to bring Plinabulin to market in the near future for patients with neutropenia, a condition that is vastly underserved in the market.”
“This is an important moment in BeyondSpring’s history that will lead to a quicker progression through the Company’s clinical trials, as we continue to advance Plinabulin as a first-in-class treatment for chemotherapy-induced neutropenia, which hospitalizes more than 60,000 patients in the U.S. each year,” added Dr. Ramon Mohanlal, BeyondSpring Chief Medical Officer, who also leads the partnering efforts at BeyondSpring. “Our continued growth underscores BeyondSpring’s ability to leverage a variety of resources to develop drugs in a time- and cost-efficient manner, and we look forward to having top line results, later in 2017, comparing Plinabulin with Pegfilgrastim from the Phase 2 portion of this Phase 2/3 trial.”
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’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical program in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market.
Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Plinabulin is given as a single IV infusion in each cycle, 30 minutes after completion of the chemotherapy, offering same day dosing, whereas G-CSF is given 24 hours after chemotherapy. In addition, the use of Plinabulin is not associated with bone pain, which is a frequent side effect with G-CSF.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.