TORONTO, Aug 26 (Reuters) - Canadian biotech company Neurochem Inc NRM.TO said on Sunday that a Phase III clinical trial had not demonstrated a statistically significant difference in favor of its tramiprosate treatment for Alzheimer’s Disease.
The North American trial for tramiprosate involved 1,052 patients in 67 centers in Canada and the United States. Patients, who were suffering from mild-to-moderate Alzheimer’s Disease. received either a placebo or one of two doses of the drug, but Neurochem said results were inconclusive.
“Due to significant interference from high between-site variations that complicated the statistical analyses beyond expectations, it is not possible to draw definitive conclusions with respect to the treatment effect of tramiprosate,” it said.
The Canadian biotech company will discuss results of the trial, and of its discussions with the U.S. Food and Drug Administration on a conference call on Monday.
“The agency...advised that neither the proposed adjusted models nor any further adjustments could be used for this trial to provide results in support of a claim of clinical efficacy,” Neurochem said.
Neurochem said last month that the FDA had designated tramiprosate, or Alzhamed, as a fast-track product, allowing accelerated review and development. Its shares rose steeply in response.
The company said it had set up a special advisory board to analyze data from the trial and consider future options. It was considering how to modify a European Phase III trial of the drug.
((Reporting by Janet Guttsman, editing by Lincoln Feast; Reuters Messaging: firstname.lastname@example.org. Telephone: +1-416-941-8100)) Keywords: NEUROCHEM TRIAL
C Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nN26381116