FDAnews
www.fdanews.com/articles/63521-astrazeneca-ends-development-of-post-stroke-treatment

ASTRAZENECA ENDS DEVELOPMENT OF POST-STROKE TREATMENT

October 27, 2006

Renovis has announced that a pivotal Phase III study of NXY-059 (SAINT II) conducted by its exclusive licensee, AstraZeneca, did not demonstrate a statistically significant reduction on the primary endpoint of stroke-related disability in patients treated with NXY-059, as assessed versus placebo using the modified Rankin Scale.

In a secondary endpoint in the SAINT II study, treatment with NXY-059 did not result in a statistically significant improvement in neurological status versus placebo on the National Institute of Health Stroke Scale. There was also no evidence of NXY-059 lowering the incidence of symptomatic intracranial hemorrhage when administered with the approved thrombolytic agent, rt-PA. The incidence and profile of adverse events in patients in SAINT II receiving NXY-059 was similar to placebo. The mortality rate was also comparable in the treatment and placebo groups.

"Unfortunately, the data are clear and although we will continue to review the results from SAINT I and SAINT II, we understand AstraZeneca's decision to discontinue development of NXY-059," Corey Goodman, president and CEO of Renovis, said.