Gilead's GS 92 to enter Ph I clinical testing

US drugmaker Gilead Sciences says that its novel nucleotide analog, GS 9219, has shown promising anticancer activity in preclinical models which has prompted it to advance the agent to Phase I clinical studies later this year. GS 9219 was cleared for Phase I human trials by the US Food and Drug Administration after Gilead's submission of an Investigational New Drug application for the compound, in late 2006. The firm expects to initiate a Phase I study of patients with non-Hodgkin's lymphoma and chronic lymphocytic leukemia later this year at US cancer centers.

The agent is a prodrug of the nucleotide analog 9-(2-phosphonylmethoxyethyl) guanine (PMEG). It is selectively enriched in lymphocytes, and therefore may have potential applications in combating hematological malignancies. As an investigational compound, GS 9219 has not been determined safe or efficacious in humans, Gilead noted.