- A Phase 2 clinical trial evaluating BeyondSpring's (BYSI -4%) Plinabulin, combined with Amgen's (AMGN -1.9%) Neulasta (pegfilgrastim), for the prevention of chemo-induced neutropenia (CIN) low and bone pain demonstrated a treatment effect.
- 50% of patients receiving high-risk TAC (docetaxel, doxorubicin and cyclophosphamide) chemo who also received Plinabulin + Neulasta experienced grade 3 (serious) or grade 4 (life-threatening) neutropenia compared to 81% who received Neulasta only (p=0.0456). Duration of grade 3/4 neutropenia was 0.94 days in the Plinabulin group compared to 1.38 days for the Neulasta-only group.
- 6% of patients receiving Plinabulin + Neulasta experienced at least one day of bone pain compared to 95% who received Neulasta alone (p<0.0001).
- Plinabulin is a marine-derived small molecule that contributes to the prevention of neutropenia by activating a protein called GEF-H1 that plays a key role in signaling pathways affecting the levels of neutrophils.
- Neutropenia is an abnormally low level of neutrophils (a type of white blood cell that plays a key role in fighting infections) in the blood.
- The current standard of care for treating CIN is G-CSF agents like Neulasta or Neupogen (filgrastim), but they are associated with bone pain and do not eliminate the risk of grade 3/4 neutropenia.
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