Biokine receives Orphan Drug designation for mobilization of stem cells in cancer
Biokine Therapeutics, an Israel-based biopharmaceutical company, has received Orphan Drug designation from the FDA for the mobilization of hematopoietic stem cells from bone marrow into peripheral blood for collection and subsequent transplantation in patients with hematological cancers.
"BKT140 is uniquely positioned to enter the fast evolving market for stem cell mobilization for hematological malignancies,” said Dr. Laurence Shaw, chairman of Biokine's board of directors. “In these cost constrained times, BKT140, which allows for a reduction in the cost of patient care, is a highly competitive drug. In addition, in both preclinical and clinical studies BKT140 had shown that by targeting the chemokine receptor CXCR4, BKT140 also appears to have the potential to treat malignancies involving this key receptor.”
Earlier this year, Biokine received FDA approval to conduct a phase II clinical study for stem cell mobilization in multiple myeloma and non-Hodgkin's lymphoma patients utilizing BKT140. Biokine had previously completed a phase I/II clinical study at several medical centers in Israel which indicated both the drug's safety and efficacy and its ability to shorten the number of treatment days and subsequent aphaeresis procedures.
Biokine Therapeutics is an emerging biopharmaceutical company that is developing novel therapeutic agents for use in stem cell cancer therapeutics, cancer and in the treatment of autoimmune and inflammatory diseases. The company has a proprietary Chemohit drug discovery technology and has several preclinical compounds in development.