Patients in the initial 10 mcg/kg Maxy-G34 cohort met the safety criterion for duration of neutropenia (less than or equal to five days of severe neutropenia). No serious adverse events or immunogenicity issues were noted for the initial cohort of patients on 10 mcg/kg of Maxy-G34. Data available from multiple patients after multiple doses revealed no binding antibodies, and drug response in all patients has been sustained. The Data Safety Monitoring Board overseeing the trial approved escalation to the second dose level of 30 mcg/kg Maxy-G34. The first cohort of patients at this level is enrolled and currently undergoing treatment.
The primary objective of the Phase IIa trial is to evaluate safety and efficacy of Maxy-G34 in TAC (docetaxel, adriamycin and cyclophosphamide)-treated breast cancer patients and to identify one or more doses of Maxy-G34 that effectively treat chemotherapy-induced neutropenia. Patient tolerability, safety, and immunogenicity will be monitored and assessed. Data will also be collected on the pharmacokinetic properties of Maxy-G34 and the mobilization of CD34+ stem cells.
Maxy-G34 is a novel pegylated granulocyte colony stimulating factor (PEG-GCSF) designed to treat chemotherapy-induced neutropenia.