Maxygen has completed its phase IIa clinical study in breast cancer patients, in which MAXY-G34 was safe and effective in reducing chemotherapy-induced neutropenia (CIN).
Phase IIa study were to evaluate safety, tolerability, pharmacokinetics and efficacy of MAXY-G34 in breast cancer patients.
In the study, all doses of MAXY-G34 effectively reduced the duration of severe neutropenia (DSN) observed, compared to the above-referenced historical controls. Importantly, no MAXY-G34 patients required rescue therapy due to insufficient efficacy of MAXY-G34. The mean duration of severe neutropenia for MAXY-G34 dose groups in chemotherapy cycle 1 ranged from 0.8 to 2.2 days, versus 2.0 days in the Neulasta control group.
Russell Howard, CEO of Maxygen, said: “We are encouraged by these clinical data and FDA feedback on Maxygen’s proposed development plan for MAXY-G34 in CIN. These events further confirm that, with the right partnership, a timely and cost effective development pathway to BLA filing can be achieved in 2013. MAXY-G34, with a product profile similar to Neulasta, could be the 2nd entrant in the multi-billion dollar, long-acting G-CSF market.”