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news.Avicena Group has reported that the US Patent and Trademark Office has granted US patent number 7,285,573 for the use of the company's proprietary drug candidates for the treatment of amyotrophic lateral sclerosis.
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This patent expands the company’s existing US and international IP portfolio to 22 issued patents and 30 pending patents.
It also provides further protection for the company’s growing portfolio of drug candidates for the treatment of amyotrophic lateral sclerosis (ALS), which are designed to slow disease progression and improve the quality of life for patients. The company’s present ALS drug candidates, AL-02 and AL-08, have been the subjects of an extensive body of clinical research including Phase II/III trials conducted by the Northeast ALS Consortium, Carolinas Medical Center and Utrecht University.
The pooled analysis of these studies showed an increase of 1.47-fold in median survival compared to results in patients taking a placebo. Portions of these data have been presented to the FDA and formed the basis for Avicena Group’s intent to initiate a confirmatory Phase III trial in 2008. This study will evaluate AL-02’s effect on the primary endpoint of median survival and secondary endpoints of ALS functional scores.
Belinda Nivaggioli, chairman and CEO of Avicena, said: “Avicena continues to execute its critical milestones. While we are advancing our drug candidates through clinical trials, including the ongoing Phase III trial in Parkinson’s disease, we are also securing patent protection as we move closer to potential commercialization of our therapeutic candidates. We are very excited about the prospects of AL-02 for the treatment of ALS and are gearing up to initiate the confirmatory Phase III early 2008.”