Ride For Life

Thursday July 6, 8:00 am ET

PALO ALTO, Calif., July 6 /PRNewswire-FirstCall/ -- Avicena Group, Inc. ("Avicena"), a developer of novel pharmaceutical and therapeutic products, announced today that 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 (ALS or Lou Gehrig's Disease) has been initiated. Investigators will assess the efficacy, as well as the safety and tolerability, of ALS-08 in separate combinations with celecoxib (a COX-2 inhibitor) and minocycline in patients with ALS.

"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 Paul H. Gordon, M.D., assistant professor of neurology, associate medical director of the MDA/ALS Research Center at Columbia University and the study's lead investigator. "We hope to replicate these findings in ALS patients while also determining which of these two combinations has the most significant impact on disease progression."

This six-month, multi-center, double-blind controlled 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. ALS-08 is a proprietary creatine-derivative that is being developed by Avicena as a potential therapeutic for ALS.

"This is a very exciting study for Avicena as it advances another of our proprietary ALS drug candidates into Phase II development," said Belinda Tsao- Nivaggioli, Ph.D., Avicena's chief executive officer. "We are dedicated to developing and delivering novel and effective therapies to this patient population and believe that our lead ALS compound, ALS-02, as well as a combination therapy incorporating ALS-08, have the potential to offer much needed treatment options to these individuals."

This study is also supported by the ALS Association, Ride for Life, and the Russ Bowen and Spina Family foundations. For additional information about participating sites, contact Carolyn Doorish at cd2141@columbia.edu.