Pending authorization, the phase I/IIa clinical trial of Neugranin will be a safety and tolerability trial in patients with breast cancer. In the first phase of the study, subjects will receive a subcutaneous dose of Neugranin prior to receiving myelosuppressive chemotherapy such as Docetaxel.
In the second phase, patients will be given chemotherapy prior to dosing with Neugranin, while a positive control group will receive Neulasta, a pegylated form of G-CSF. Evaluations will include safety and tolerability, pharmacokinetic profiles, and, additionally, in the second phase, signals for effect.
Previously, findings have suggested that Neugranin may have a profile comparable to that of Neulasta, the current market leader for the treatment of patients who have reduced white blood cells (neutropenia) and may provide an affordable treatment alternative to prevent and treat chemotherapy-induced neutropenia in cancer patients.
Neulasta alone generated $2.2 billion in sales in 2005. CoGenesys believes that Neugranin has the potential to be the second long-acting G-CSF product to enter this large market.