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12:00 AM
Oct 30, 2006
 |  BioCentury  |  Product Development

Stroke frustrates yet again

Stroke remains one of the toughest areas of drug development, and the two main approaches - neuroprotection and clot busting - both were cast under new clouds last week. Most consequential was the failure of NXY-059 from Renovis Inc. in the Phase III SAINT II trial - one in a long line of disappointments for the concept of neuroprotection in stroke that raises the question of whether the whole idea should be dropped. Of less broad import was the three-day suspension of Phase III enrollment of Paion AG's desmoteplase to review an undisclosed safety signal.

The news also had broader and narrower implications for each company. RNVS now finds itself as a preclinical company, while Paion looks like it will keep its timeline for desmoteplase.

RNVS's NXY-059 news was particularly disappointing, as the compound met the primary endpoint of a significant reduction in stroke-related disability in the Phase III SAINT I trial(see BioCentury, June 6, 2005). But in SAINT II - which enrolled more than 3,200 patients and was almost double the size of SAINT I - there was no such significant reduction on that endpoint. The compound also failed to show a significant improvement in neurological status, a secondary endpoint.

"The SAINT II results are shocking," said President and CEO Corey Goodman. "I looked at table after table and was more and more surprised - all the things that worked in SAINT I didn't even show a trend in SAINT II. The results are valid, as the trial was well run. The data are clean and remarkably consistent in showing nothing."

AstraZeneca plc (LSE:AZN; AZN, London, U.K.), which ran both trials, is discontinuing development of NXY-059 and giving the compound back to RNVS (South San Francisco, Calif.).

NXY-059 is a small molecule that attracts,...

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