Maxygen Initiates Phase IIa Clinical Trial of MAXY-G34 in Breast Cancer Patients
Maxygen announced that it has initiated a Phase IIa trial to evaluate the efficacy, safety and tolerability of MAXY-G34 in the treatment of chemotherapy-induced neutropenia.
MAXY-G34 is a novel pegylated granulocyte colony-stimulating factor (PEG-GCSF) shown in preclinical and Phase I studies to have novel and potentially superior properties compared with the current PEG-GCSF therapy, Maxygen said.
The Phase IIa trial, which will be conducted at multiple centers in Eastern Europe, is the first trial of MAXY-G34 in patients, the company said.
Approximately 30 patients with Stage I-III breast cancer will undergo TAC (docetaxel, adriamycin and cyclophosphamide) chemotherapy followed by next-day administration of either MAXY-G34 or Neulasta. The trial is designed as a multiple ascending-dose study, with planned doses at 10, 30, 60 or 100 mg/kg of MAXY-G34 compared with 6 mg of Neulasta. Both MAXY-G34 and Neulasta will be administered as a subcutaneous injection once per chemotherapy cycle, the company said.
According to the company, the primary objective of the Phase IIa trial is 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.