Phase III trial of F 627 meets primary endpoint in chemotherapy-induced neutropenia.- Generon.

Generon Corporation announced that the first pivotal phase III study in the U.S. for F 627 to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients met the primary endpoint. F 627 (Benegrastim / BineutaTM) is a recombinant human granulocyte colony-stimulating factor (rhG-CSF) dimer with a best-in-class potential to manage CIN in cancer patients. The primary endpoint was to shorten the duration in days of grade 4 (severe) neutropenia in the first chemotherapy cycle. Patients treated with F 627 demonstrated significantly reduced duration of severe neutropenia compared to patents in placebo group (P<0.0001).>

This Phase III trial is a randomized, multi-center, double-blind, placebo controlled Phase III study of the efficacy and safety of a once-per-cycle dose of F 627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) + Adriamycin (doxorubicin)). Subjects were randomized to F 627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects received either 20 mg fixed dose F 627 or Placebo. The subjects' absolute neutrophil count (ANC) was measured each day post chemotherapy administration until ANC levels exceeded 2.0 x 109/L, then the ANC value was determined every three days until the next chemotherapy cycle.

This is one of two pivotal Phase III studies required for BLA submission in the US. The second Phase III study is under an SPA with the FDA and currently ongoing.