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BeyondSpring Announces Initiation of Phase 3 Clinical Development for Plinabulin for Prevention of Chemotherapy-Induced Neutropenia
Dr. Blayney, Professor of Medicine at
The current standard of care for CIN is G-CSF, which accelerates maturation of neutrophils and increases proliferation and expansion of neutrophil precursors in the bone marrow. While G-CSF reduces DSN, it cannot be given on the same day as chemotherapy, and the expansion of the bone marrow causes an unusual bone pain in 10 to 29 percent of patients. This unusual, expansive bone pain causes some patients to discontinue treatment. Because of Plinabulin’s novel mechanism of action, this expansive bone pain has not been observed in previous clinical studies (non-small cell lung cancer or NSCLC Study 100 and Study 101). In the Phase 2 portion of Study 105, a single dose of Plinabulin, 30 minutes after docetaxel, demonstrated similar efficacy relative to long-acting G-CSF (Pegfilgrastim/Neulasta) dosed the next day in the first 21-day cycle (the primary efficacy endpoint). The study achieved its primary objective in identifying the recommended Phase 3 dose (20 mg/m2) with a clear dose-dependent response; DSN is 0.38 days for Plinabulin at 20 mg/m2. This data was presented at the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium in January. Plinabulin has also demonstrated anti-cancer activity in Study 100 and Study 101 and is now in Phase 3 clinical development for the treatment of NSCLC (Study 103).
The Phase 3 portion of Study 105 is expected to enroll approximately 150 cancer patients at 55 sites in the U.S.,
“In the Phase 2 portion of Study 105, more than 50 patients were enrolled in six weeks among 40 sites globally. We are excited to advance this study and look forward to providing Phase 3 interim data in the second half of 2018,” said Dr.
“Initiating the Phase 3 portion for Study 105 with Plinabulin for CIN prevention is a major milestone for
About Chemotherapy-Induced Neutropenia (CIN)
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 10 to 29 percent of 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
Based upon the Company’s discussions with the
Cautionary Note Regarding Forward-Looking Statements
Neulasta is a registered trademark of