www.fdanews.com/articles/101048-u-s-issues-patent-for-avicena-8217-s-als-compounds
U.S. Issues Patent for Avicena’s ALS Compounds
November 14, 2007
The U.S. Patent and Trademark Office has granted the Avicena Group a patent for its amyotrophic lateral sclerosis (ALS) drug candidates.
The candidates, AL-02 and AL-08, have undergone several trials. The pooled analysis of these studies showed an increase of 1.47-fold in median survival compared with patients taking a placebo, Avicena said.
Portions of these data have been presented to the FDA and formed the basis for the company’s plans to start a Phase III trial in 2008. This study will evaluate AL-02’s effect on the primary endpoint of median survival and secondary endpoint of ALS functional scores.