NEW YORK, June 25, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global, clinical-stage biopharmaceutical company focused on the development of transformative cancer therapies, announced today that Dr. Yuankai Shi presented positive data from the Phase 2 portion of Study 105, a prospective Phase 2/3 trial of Plinabulin, its lead candidate, for the prevention of chemotherapy-induced neutropenia (CIN), in a keynote presentation at the 12th Annual Chinese Symposium on Medical Oncology (CSMO) and the 7th Annual Meeting of the Chinese Association for Clinical Oncologists (CACO) on Saturday, June 23, 2018, at the Radegast Lake View Hotel in Beijing. Dr. Shi is the Principal Investigator in China for BeyondSpring’s Studies 105 and 106 for the prevention of CIN, as well as the Co-Principal Investigator in China for Study 103 for the treatment of advanced non-small cell lung cancer (NSCLC).
“In clinical studies to date, Plinabulin has demonstrated dual functions: First, in maintaining neutrophil counts within the normal range to prevent CIN, as well as anti-cancer efficacy in terms of prolonging the duration of anti-cancer response (DoR) in NSCLC patients, compared to docetaxel alone, with the aim of increasing overall survival,” said Dr. Shi, Director of the Oncology Department at The Cancer Hospital of the Chinese Academy of Medical Sciences and the China Chairman of National Comprehensive Cancer Network (NCCN) guidelines for neutropenia management. “China is the second-largest cancer market in the world, with more than four million new cancer patients each year and up to 65 percent using chemotherapy, underscoring the vast scale of the unmet medical needs and commercial potential that Plinabulin may address. As a physician focused on the treatment of lung cancer and Principal Investigator for all previous G-CSF drugs approved in China, I am very experienced with G-CSF, including its limitations. I am very encouraged by Plinabulin’s clinical data to date and believe that it has the potential to be a significant new advancement for combating CIN as a valid alternative to G-CSF, aiding patients all over the world.”
Dr. Shi presented the results of Phase 2 of Study 105, demonstrating that patients treated with Plinabulin reported less bone pain while being equally protected against severe neutropenia compared to patients treated with Neulasta® (pegfilgrastim), a long-acting G-CSF. G-CSF accelerates maturation and proliferation of neutrophil precursors in bone marrow, and is given 24 hours after chemotherapy and causes severe bone pain in some patients. The Phase 2 data showed that patients who were given Plinabulin maintained median absolute neutrophil counts within normal range, whereas Neulasta caused median absolute neutrophil counts much higher than the normal range, which may lead to bone marrow exhaustion and suppression of the immune system.
“There is a growing body of scientific evidence suggesting that Plinabulin has the potential for a superior overall product profile in preventing CIN compared to Neulasta, and as evidenced by positive physician feedback on our scientific presentations and educational initiatives to date. There is increasing awareness within the medical community— particularly among Chinese oncologists who regularly treat patients with chemotherapy—of Plinabulin’s significant potential, which could help build momentum in our launch efforts in China if Plinabulin is approved,” said Dr. Lan Huang, BeyondSpring CEO. “We are looking forward to the interim analysis from Phase 3 of Study 105 in the fourth quarter of this year. Provided the Phase 3 data are confirmative of the Phase 2 data, we plan to submit a New Drug Application in China for Plinabulin for CIN prevention in late 2018 or early 2019.”
About Chemotherapy-Induced Neutropenia (CIN)
CIN is a common side effect in cancer patients that involves the destruction of a type of white blood cell (neutrophil) that is critical in defense against infections. Patients with severe, or grade 4, neutropenia have an abnormally low concentration of neutrophils, making them more susceptible to severe bacterial and fungal infections and sepsis, which can require hospitalization. When severe neutropenia occurs, the chemotherapy dose has to be reduced or interrupted until the neutropenia subsides. Up to 18 percent of patients could die from first-cycle chemotherapy treatment, according to Cancer Network. The severity of neutropenia is measured by duration of severe neutropenia (DSN), which measures the days a patient has a dangerously low neutrophil count. DSN of less than one day is considered clinically meaningful.
The current standard of care for prevention of CIN is G-CSF, which accelerates maturation and proliferation of neutrophil precursors, and, when administered the day after chemotherapy, reduces DSN of docetaxel to less than one day. G-CSF stimulates the expansion and proliferation of neutrophil precursors in the central part (medullary compartment) of bone marrow, which may cause severe bone pain, leading to discontinuation of chemotherapy treatment. G-CSF also has the limitation of second-day dosing after chemotherapy treatment. For the intermediate-risk chemotherapy market, which represents 60 percent of cases, NCCN guidelines recommend G-CSF treatment only in limited, patient-specific circumstances.
Global sales of G-CSF totaled more than $8 billion in 2016, with the current G-CSF market leader, Neulasta, contributing approximately $6 billion. In the U.S., Neulasta sales totaled more than $4 billion in 2016. According to the CDC, about 650,000 patients receive outpatient chemotherapy in the U.S. Approximately four million new patients are diagnosed with cancer in China each year, according to the American Cancer Journal of Clinicians, and up to 65 percent of patients use chemotherapy, according to a nationwide study.
Plinabulin, a small molecule derived from a marine fermentation product (phenylahistin), is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of CIN and as an anticancer therapy in NSCLC. In addition to direct cytotoxic effects leading to tumor cell death, studies of Plinabulin's mechanism of action indicate that following tubulin binding, Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 affects downstream molecular pathways leading to increased dendritic cell maturation and antigen induced T-cell activation. With regard to CIN, nonclinical testing indicates that Plinabulin releases a chemotherapy induced block in the differentiation of bone marrow cells into neutrophils, allowing for a reduction in the incidence and duration of neutropenia.
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 a ubiquitination platform. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has a seasoned management team with many years of experience bringing drugs to the global market.
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, additional competition in the market, and other risk factors referred to in BeyondSpring’s current Form 20-F on file with the U.S. Securities and Exchange Commission. 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.
Neulasta is a registered trademark of Amgen, Inc.
Laura Perry or Joe Rayne