CoGenesys begins research on infection drug

Neugranin is a long-acting form of Granulocyte Colony Stimulating Factor (G-CSF). CoGenesys believes that Neugranin has the potential to be the second long-acting G-CSF product to enter the large market for colony stimulating factors. Neulasta, manufactured by Amgen, is currently the only long-acting G-CSF product presently approved in the world.

Serious infections and hospitalization can result from neutropenia, and the presence of neutropenia-associated fever often necessitates the reduction of the dose of chemotherapy in patients or can cause a delay in the administration of the next cycle of chemotherapy.

CoGenesys' phase I-IIa study will evaluate safety and tolerability, pharmacokinetic profiles, and in the second phase, signals for effect in breast cancer patients. In the first phase of the study, subjects will receive a subcutaneous dose of Neugranin prior to receiving myelosuppressive chemotherapy. In the second phase, patients will receive their chemotherapy prior to dosing, and a positive control group will receive Neulasta.

“The phase I-IIa study builds on previous preclinical research demonstrating that our long-acting form of G-CSF will likely have a therapeutic profile comparable to that of Neulasta, the current market leader for the treatment of patients with neutropenia,” said Martha Reitman, CoGenesys' senior vice president, Medical Affairs.

“We also believe that Neugranin will have a competitive cost-of-goods profile and therefore may represent an affordable treatment alternative to current therapy.”