Generon Presented Positive Phase III Results From a Double-Blind, Placebo Controlled-Clinical Trial of F-627 in Women with Breast Cancer Receiving Myelotoxic Chemotherapy
Generon BioMed Holding Ltd. (Generon), announced today at the annual San Antonio Breast Cancer Symposium (SABCS), positive results from a placebo-controlled trial with F-627, a recombinant human Granulocyte Colony Stimulating Factor (rhG-CSF) protein, designed using Generon’s DikineTM technology platform.
Led by Principle Investigator Dr. John Glaspy, Estelle, Abe and Marjorie Endowed Chair in Cancer Research at the Jonsson Comprehensive Cancer Center of UCLA, this global study of 122 woman with stage II-IV breast cancer receiving Myelotoxic chemotherapy demonstrates that subcutaneous administration of F-627 significantly reduced the duration of Grade 4 (severe) neutropenia in chemotherapy cycle 1 (P<0.0001); the mean treatment difference was 2.8 days (1.1 days vs. 3.9 days in the placebo arm). F-627 administration also resulted in lower incidence and shorter duration of Grade 4, Grade 3 and Grade 2 neutropenia. Other significant results included the finding that treatment with F-627 significantly reduced the incidence of febrile neutropenia (FN) (P<0.0016). The incidence of FN in the experimental arm was 4.8% and 28.2% in the placebo arm during cycle 1. Subjects in the experimental arm also had lower rates of antibiotic medication and pain medication use. In this study, F-627 was shown to be safe and well tolerated with no deaths, no injection site reactions and less gastrointestinal AEs (diarrhea, vomiting, stomatitis, and gastritis) than the placebo arm. During cycle 1 in the experimental arm, the five most common TEAEs (incidence rate >10%) were leukopenia, anemia, thrombocytopenia, nausea, and alopecia. Across all cycles, there were 17 SAEs from 15 subjects of which 15 were FN.
A single subcutaneous injection of F-627 significantly reduced the duration and incidence of severe neutropenia and febrile neutropenia while maintaining an excellent safety profile in patients with breast cancer undergoing high-dose chemotherapy.
Dr. Glaspy indicated that F-627 would provide an alternative treatment for patients with breast cancer and severe neutropenia secondary to myelotoxic chemotherapy. “The successful completion of this phase III trial exemplifies our continued commitment to developing innovative medicines on our various platforms that have the potential to treat patients with cancer” said Dr. William Daley, Generon’s Chief Medical Officer.
Dr. Daley also indicated that Yifan Pharmaceuticals, a controlling parent company of Generon, congratulated Generon’s team on the continued effort to develop innovative therapies. “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” he commented.
F-627, a rhG-CSF dimer, is a once-per-cycle therapy for the preventive management of neutropenia. Produced in Chinese Hamster Ovary (CHO) cells in serum-free cultures, F-627 leverages Generon’s proprietary Dimeric Cytokine (DiKineTM) technology platform to create an immunoglobulin-like dimeric structure, providing improved efficacy and a longer half-life. This product candidate is intended to treat cancer patients with neutropenia secondary to myelotoxic chemotherapy.
About Generon Corporation
Generon BioMed Holding Ltd. is a privately held and leading Biotechnology Company located in Shanghai, China focusing on the development of innovative biological therapies for patients worldwide.
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