Keryx Biopharmaceuticals Inc has contracted with PolyPeptide Laboratories Group for the scaled up production of KRX-123, a peptide drug candidate for the treatment of hormone refractory prostate cancer.
Keryx believes this contract represents an important milestone in its plan to initiate clinical trials in humans utilizing KRX-123. KRX-123, a specific sequence-based kinase inhibitor generated by Keryx's KinAce technology platform, will be synthesized in accordance with Good Manufacturing Practices (GMP), which is the standard for manufacturing of drug candidates to be used in human clinical trials. PolyPeptide, which has agreed to produce sufficient quantities of KRX-123 to allow completion of Phase I/II trials, is one of the world's leading groups specializing in industrial scale manufacture of custom and generic peptides for therapeutic applications, having been involved in large scale pharmaceutical peptide manufacturing for over forty years.
Commenting on the contract with PolyPeptide, Dr. Benjamin Corn, CEO and President of Keryx Biopharmaceuticals, stated, "We are excited about commencing GMP manufacturing of KRX-123. We believe this milestone represents an important step in our development program as we prepare to enter clinical trials in humans with this compound."
In addition, Keryx also disclosed that recent in-vivo experiments in a model of hormone refractory prostate cancer may provide evidence of the potential efficacy of KRX-123 for treating this disease. Histological analysis of this research conducted at the Hadassah Hospital in Jerusalem, suggests that the cancer cells in tumors treated with KRX-123 revert to a less aggressive morphology, and that treated tumors had higher levels of apoptosis and fibrosis when compared to untreated control tumors.
Discussing the in-vivo results, Dr. Morris Laster, Chairman of Keryx Biopharmaceuticals, said, "We are pleased with the latest in-vivo results that have been generated. We believe that the histology data shows that KRX-123 causes apoptosis of the hormone refractory prostate cancer cells and reinforces the potential utility of KRX-123 in treating this disease."