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news.Avicena Group has initiated a phase II clinical trial of two combination therapies incorporating ALS-08, one of its proprietary drug candidates for the treatment of amyotrophic lateral sclerosis.
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Investigators will assess the efficacy, as well as the safety and tolerability, of ALS-08 in separate combinations with celecoxib (marketed as Celebrex by Pfizer) and minocycline in patients with amyotrophic lateral sclerosis (ALS), otherwise known as Lou Gehrig’s disease.
“We are enthused about this study based on the fact that the ALS-08/celecoxib and ALS-08/minocycline combinations have demonstrated additive effects in animal models of ALS, reducing neurodegeneration and prolonging survival more than individual agents alone,” said Dr Paul Gordon, assistant professor of neurology at Columbia University and the study’s lead investigator.
The six-month, multicenter trial will enroll up to 120 ALS patients and randomly assign them to one of the two combination treatment arms.
The study’s primary endpoint is the change in the revised ALS Functional Rating Scale (ALSFRS-R). Investigators will also assess a number of secondary outcomes including safety and tolerability, as well as additional efficacy measurements related to the ALS-08 combinations.