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Avicena Phase III results limited - drug may reduce mortality rates

May 10, 2006

Avicena said its potential drug for Lou Gehrig's disease (ALS-02) failed in trials to improve muscle strength and function. The drug did show a trend of reduced mortality. Further study will be needed with the hopes of FDA approval in the future.

What People Are Saying:
"US biotech company Avicena's drug candidate ALS-02 has generated disappointing results in a phase III trial evaluating the drug in the treatment of the neurodegenerative disease amyotrophic lateral sclerosis, or Lou Gehrig's disease."
Pharmaceutical Business Review

Avicena said its phase 3 study of ALS-02, "showed no statistically significant difference between ALS-02 and placebo with regard to the study's primary and secondary endpoints of measuring muscle fatigue, muscle strength and functional scores.

Avicena added that the drug candidate did appear to decrease mortality, based on comparison of data from the company's study with data from an earlier trial of ALS-02 done by the North East ALS Consortium.

"We are very interested in further exploring this trend toward decreased mortality," said Avicena Chief Executive Officer Belinda Tsao-Nivaggioli. "We are hopeful that together with (the Food and Drug Administration) we will be able to identify a clear path to market for ALS-02,".

Tsao-Nivaggioli added, "It is important to note that the one currently approved treatment for patients suffering from ALS offers only limited, short-term survival benefit and has not demonstrated benefit in regard to measures of muscle strength and neurological function."

Avicena said it is currently compiling a meta-analysis of the recently completed phase 2 and 3 studies of ALS-02, along with past studies of the drug to determine with the FDA "the next development steps" for the treatment.