Plinabulin is a novel small molecule with immune-enhancing effects and anti-cancer activity that is given by IV infusion – one hour after chemotherapy – and has the potential to be a safe, cost-effective and convenient alternative to G-CSF, the current standard of care for chemotherapy-induced Neutropenia, with much less bone pain and a more favorable safety profile. Plinabulin offers a same-day dosing advantage over G-CSF, which, per product label, should be administered 24 hours after chemotherapy (next-day dosing), by which time a significant insult to Neutrophils has occurred. Recent data presented at ASH also showed that Plinabulin reduced the clinical sequelae associated with Docetaxel-induced Neutropenia – i.e., infections, sepsis, hospitalizations and the need for Docetaxel dose reductions.
"Going from concept to a FDA-accepted IND within six months could only be achieved through having strong Phase 2 clinical data," added Dr. Ramon Mohanlal, M.D., Ph.D., BeyondSpring Chief Medical Officer. "The acceptance of BeyondSpring's IND application reflects the U.S. FDA's commitment to working with BeyondSpring on this novel approach to address a serious and life-threatening condition, like chemotherapy-induced Neutropenia. This also illustrates BeyondSpring's ability to successfully plan and execute in an expedited and efficient manner."
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.
More than 60,000 patients are hospitalized each year for chemotherapy-induced severe Neutropenia, which is associated with fever, infections and death in up to 18 percent of these cases. When severe Neutropenia occurs, the chemotherapy dose has to be reduced or interrupted until the Neutropenia subsides. This reduction or interruption causes patients to receive suboptimal chemotherapy cancer treatment.
"The FDA's acceptance of BeyondSpring's IND application for Plinabulin for the prevention of chemotherapy-induced Neutropenia marks an important regulatory milestone for the Company," concluded Dr. Lan Huang, BeyondSpring CEO. "With this opportunity, the Company is well-positioned to deliver near-term returns to our investors. It also highlights the dedication and hard work of a team that has already built a strong foundation of data for Plinabulin over the years, entered the Phase 3 trial for non-small cell lung cancer and is committed to developing innovative cancer therapies globally to address unmet medical needs. Cancer patients are in need of effective, affordable, safe and convenient treatment options, and Plinabulin has the potential to be a breakthrough solution to these challenges."
About BeyondSpring Pharmaceuticals
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 has advanced its lead asset, Plinabulin, into a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer. The Company is also planning a Phase 2/3 clinical trial for Plinabulin in the prevention of chemotherapy-induced Neutropenia. BeyondSpring's experienced management team brought a combined 30+ drugs to market.
Plinabulin is an innovative small molecule agent that has multiple mechanisms of action, with an immune-enhancing mechanism and tumor vasculature targeting and activating JNK pathway to induce cancer cell apoptosis.
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SOURCE BeyondSpring Pharmaceuticals