The data shows that Plinabulin, a novel small molecule with immune-enhancing effects and anti-cancer activity that is given by IV infusion (one hour after chemotherapy), 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 same-day dosing versus next-day dosing for G-CSF, by which time a significant insult to Neutrophils has occurred. Plinabulin also reduced the clinical sequelae associated with Docetaxel-induced Neutropenia (infections, hospitalizations, the need for Docetaxel dose reductions and G-CSF use). Additionally, in the Phase 2 study for non-small cell lung cancer patients, Plinabulin with one dose on Day One of a 21-day cycle at 20 mg/m2 or at 30 mg/m2 reduced grade 4 Neutropenia defined as absolute Neutrophil count (ANC) <0.5 X 10^9 cells/L from 33 percent to <5 percent (p=0.0002). Plinabulin's Neutropenia reduction effect persists in cycle 1 to cycle 4 of Docetaxel treatment.
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 current standard of care to prevent severe chemotherapy-induced Neutropenia is G-CSF, which has notable limitations. If given on the same day of chemotherapy, G-CSF may worsen Neutropenia. G-CSF also causes bone pain in the majority of patients, which can be so severe that patients may not tolerate G-CSF. Lastly, G-CSF, including its biosimilars, is expensive-to-produce, whereas Plinabulin is an inexpensive-to-produce small molecule.
"The release of this pivotal data demonstrates that BeyondSpring is making immense progress toward revolutionizing current treatment options for Neutropenia – a serious side effect that impacts countless cancer patients who are undergoing chemotherapy," said Dr. Lan Huang, Ph.D., BeyondSpring co-founder and CEO. "Plinabulin has demonstrated its potential to be an effective, affordable, safe and convenient alternative to G-CSF and its biosimilars, and BeyondSpring is moving full speed ahead in developing this innovative, cost-effective therapeutic alternative to G-CSF for cancer patients all over the world."
"Plinabulin is being developed globally as an anticancer agent in an ongoing Phase 3 trial for non-small cell lung cancer, and now also shows clinically and statistically significant efficacy in preventing chemo-induced Neutropenia," added Dr. Ramon Mohanlal, M.D., Ph.D., BeyondSpring Chief Medical Officer. "Plinabulin's excellent target product profile for Neutropenia (i.e., superior efficacy, safety [much less bone pain], cost-effectiveness and the same-day-dosing advantage), combined with our clinical trial design with the inclusion of quality of life and pain assessments, will facilitate market access and reimbursement efforts."
The 58th ASH Annual Meeting and Exposition took place on Dec. 3 through 6, 2016, at the San Diego Convention Center. A full-text version of BeyondSpring's abstract appears on the ASH website here and was published online in the Dec. 1 supplemental volume of Blood.
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 mechanism of action, with immune enhancing mechanism, tumor vasculature targeting and activating JNK pathway to induce cancer cell apoptosis.
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SOURCE BeyondSpring Pharmaceuticals