The Investigational New Drug (IND) application to initiate phase II/III trials has been accepted by the FDA for plinabulin for the prevention of chemotherapy-induced neutropenia.
"The primary endpoint for this trial is the duration of severe neutropenia in docetaxel-treated patients in the first chemotherapy cycle, after randomization to either plinabulin or pegfilgrastim," said Douglas Blayney, MD, FACP, Professor of Medicine at Stanford University and principal investigator for the neutropenia registrational trial. "With approximately 200 chemotherapy patients slated to complete this trial, the study was designed based on the highly statistically significant data we derived from the phase II data in a lung cancer study. Plinabulin has great potential to improve the care of cancer patients worldwide."
Plinabulin is a novel small molecule with immune-enhancing effects and anti-cancer activity that is given by IV infusion-1 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. Recent data presented at the 2016 American Society of Hematology annual meeting 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 (Abstract 2508).
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 it subsides. This reduction or interruption causes patients to receive suboptimal chemotherapy cancer treatment.