Phase III Results For Pixykine In Bone Marrow Transplant

Immunex has released preliminary data from its Phase III trial of Pixykine (PIXY321) in the setting of bone marrow transplantation. The results showed that the drug was safe and raised platelet and white cell counts, but it was not found to be superior to the comparator drug, Immunex' Leukine (sargramostim).

The study involved 177 patients and was conducted at 18 medical centers across the USA, Canada and Spain. All the patients received bone marrow transplantation as a treatment for non-Hodgkin's lymphoma. Primary efficacy endpoints of time to recovery of platelets and neutrophils did not demonstrate a significant difference compared to control. Pixykine was administered twice-daily by subcutaneous injection in a divided dose of 750mcg/m2.

Immunex received approval for Leukine in the same indication in 1991, after a Phase III trial showed that the drug was significantly better than placebo in achieving six-day white cell and three-day platelet recovery. A five-day improvement over the platelet recovery level was required in the current study to demonstrate that Pixykine delivers more clinical benefit than Leukine alone.