BeyondSpring to Present Positive Data From Prospective Phase(2)
时间:2018-12-25 17:33 来源:百度新闻 作者:巧天工 点击:次
The CIN program with Plinabulin further illustrates BeyondSprings potential and our commitment to bringing first-in-class drugs to the market to serve important areas with unmet medical needs, concluded Dr. Lan Huang, BeyondSprings CEO. ASCO Poster Presentation on June 4, 2018, 8-11 a.m. CDT in Chicago The poster titled, Plinabulin (Plin), a small molecule with anti-cancer activity and a novel mechanism of action (MoA) in docetaxel (Tax)-induced neutropenia: Phase 2 results from a head-to-head comparison with Pegfilgrastim (Peg), will be presented on June 4, 2018, from 8 to 11 a.m. CDT in Hall A at McCormick Place. The poster will be part of a session titled, Developmental TherapeuticsClinical Pharmacology and Experimental Therapeutics. 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), which are a patients first line of 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 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 has the limitation of second-day dosing after chemotherapy treatment and bone pain in some patients, with some patients citing bone pain as excruciating. For the intermediate-risk chemotherapy market, which represents 60 percent of cases, National Comprehensive Cancer Network (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 4 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. About Plinabulin Plinabulin, a marine-derived small-molecule, is BeyondSprings lead asset and is currently in late-stage clinical development for the prevention of CIN and as an anticancer therapy in NSCLC. Studies of Plinabulin's mechanism 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 up-regulate 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 by reducing the neutrophil breakdown. About BeyondSpring 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. BeyondSprings 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 BeyondSprings 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. Media Relations: Caitlin Kasunich / Kathryne Hunter KCSA Strategic Communications 212.896.1241 / 212.896.1204 ckasunich@kcsa.com/khunter@kcsa.com Investor Contacts: Laura Perry / Joe Rayne Argot Partners 212.600.1902 BeyondSpring@argotpartners.com (责任编辑:波少) |