Amgen presents NESP, SD/01 and KGF data

Data from a Phase II open label dose escalation and pharmacokinetics trial showed that AMGN's novel erythropoiesis stimulating protein (NESP) had a 50 hour half-life following a single subcutaneous 0.5 ug/kg dose in 9 patients with chemotherapy-induced anemia. The researchers suggested that NESP could be dosed once weekly versus three times per week with AMGN's Epogen erythropoietin. NESP is under review in the U.S. and Europe to treat anemia associated with renal insufficiency or failure.

In a Phase II trial of 152 breast cancer patients, a single injection of 100 ug/kg SD/01 pegfilgrastim per cycle of chemotherapy was as effective in reducing the duration of severe neutropenia as daily 5ug/kg doses of AMGN's Neupogen, with a similar safety profile. For each dose regimen, 89 and 88 percent of patients, respectively, had 0-2 days of severe neutropenia and 11 and 12 percent of patients, respectively, had 3-5 days of severe neutropenia. SD/01 is a sustained duration formulation of Neupogen G-CSF. ...