Generon BioMed has reported positive results from a Phase III trial of F-627 for the treatment of women with breast cancer.
The global, double-blind, placebo controlled trial was led by the University of California Los Angeles (UCLA) Jonsson Comprehensive Cancer Center.
It included 122 women with stage II-IV breast cancer receiving myelotoxic chemotherapy.
Results showed that subcutaneous administration of F-627 reduced the duration of Grade 4 or severe neutropenia in the trial’s chemotherapy cycle I.
Administration of F-627 also reduced the incidence and shorter duration of Grade IIII, Grade III and Grade II neutropenia.
The trial showed that F-627 significantly reduced the incidence of febrile neutropenia (FN) among the subjects.
F-627 was also found to be safe and well tolerated with no deaths, no injection site reactions and reduced gastrointestinal after effects (AEs).
Generon BioMed chief medical officer Dr William Daley said: “This is yet another milestone and goal for Generon this year and is a significant step towards our mission of innovating for life.
“Generon is committed to bringing innovative oncology therapies to patients in China and the world.”
F-627 is a recombinant human Granulocyte Colony Stimulating Factor (rhG-CSF) protein developed for use as a preventive management of neutropenia.
Generon has used its Dimeric Cytokine (DiKine) technology to create F-627, which features an immunoglobulin-like dimeric structure.