CuraGen Corporation's additional results from its phase II randomised, placebo-controlled clinical trial evaluating a single dose of velafermin for the prevention of oral mucositis (OM) in patients receiving high-dose chemotherapy, with or without total body irradiation (TBI), prior to autologous bone marrow transplantation (BMT), did not reach statistical significance.
The mid-stage study of the velafermin treatment followed 212 patients after high-dose chemotherapy, with or without radiation treatments, and before getting a bone marrow transplant.
According to the company release, the phase II safety and efficacy trial was designed to evaluate a dose dependent reduction in the incidence of OM across three doses of velafermin compared to placebo.
In the lowest dose group, 0.03 milligrams per kilogram, 18 per cent of patients developed mouth sores, compared with 37 per cent in the placebo group. However, the difference was not statistically significant. Patients given higher doses of the treatment had similar mouth sore rates to placebo.
The company plans to begin a new mid-stage study on low-dose velafermin with results available by the third quarter of 2007.
CuraGen Corporation is a biopharmaceutical that develops a pipeline of novel protein, antibody, and small molecule therapeutics in the areas of oncology, inflammatory diseases, and diabetes.