To All,
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTAX: CTIC) announced today it received fast track designation from the U.S. Food and Drug Administration (FDA) for pixantrone, a novel anthracenedione, being investigated for the potential treatment of relapsed or refractory indolent non-Hodgkin's lymphoma (NHL). In granting fast track, the FDA noted that "relapsed or refractory indolent NHL is a serious and life threatening condition and is generally considered incurable. Results from a phase I and phase III study in patients with relapsed and/or refractory indolent non-Hodgkin's lymphoma suggest that pixantrone is active in this disease." The FDA also noted that the proposed phase III trial in combination with fludarabine and rituximab "has the potential to demonstrate an effect on a serious or life threatening aspect of this disease."
Damon