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 initiated its second global Phase 2/3 clinical trial of its lead asset, Plinabulin, for the prevention of chemotherapy-induced neutropenia (CIN). Study 106, initiated in China, is enrolling patients who receive TAC (taxotere, doxorubicin and cyclophosphamide) chemotherapy, which often results in severe neutropenia, to demonstrate Plinabulin’s superiority compared with Neulasta, a G-CSF. The initiation took place on Nov. 29, 2017, at the Harbin Medical University Cancer Hospital in Harbin, China, led by Co-Principal Investigator Dr. Qingyuan Zhang. Dr. Zhang previously enrolled the first patient for BeyondSpring’s Phase 2/3 study with Plinabulin in China, in combination with docetaxel (study 105), for CIN to demonstrate non-inferiority in October 2017.
“The initiation of this important global trial signifies another key milestone for BeyondSpring as we move closer to bringing Plinabulin to market in a broad label for CIN and addressing a high unmet medical need, both in China and globally, while demonstrating the impact of a truly integrative U.S. / China business model,” said Dr. Lan Huang, BeyondSpring CEO. “Additionally, we expect U.S. and European sites within the next several months. The Chinese regulatory agencies have been very supportive of Plinabulin for the Phase 3 program for the CIN indication and non-small cell lung cancer (NSCLC) indication, allowing for a shorter time-to-market. With this accelerated path, we expect the CFDA filings of our first NDAs for both the CIN and NSCLC indications potentially in 2018.”
“Plinabulin holds the promise of being a groundbreaking therapy for cancer patients – not only as an anti-cancer drug through its immune-enhancing effect but also through its ability to prevent CIN,” added Dr. Zhang. “Our center has participated in numerous global clinical trials, with up to 50 percent of our patients enrolling in trials. We have the expertise to produce quality data and the clinical resources to drive innovative drug development overall.”
Neutropenia is a common side effect of chemotherapy in cancer patients and marks 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 a high mortality risk. CIN hospitalizes more than 60,000 patients in the U.S. each year.
“CIN has been a limiting bottleneck for chemotherapy, and for the last 25 years, G-CSF has been the standard of care,” concluded Lihua Du, general manager of BeyondSpring China. “Plinabulin has the ability to significantly reduce the incidence of CIN, making it a highly valuable treatment for patients all over the world. Best of all, tapping into China’s vast resources also enables BeyondSpring to push forward with our efforts to make Plinabulin available as quickly as possible. The start of this study demonstrates BeyondSpring’s operational capabilities in China and quick advancement of the program, and we look forward to upcoming data from the ongoing Phase 2/3 trial in CIN in 2018. We believe that this data will further elucidate the unmet medical need that Plinabulin can address.”
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 University of Washington in de novo drug discovery using ubiquitination platform. 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 (CIN). 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.