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Avicena Announces Completion of Patient Enrollment for the First Stage of ALS-08 Phase II Clinical Trial for ALS

October 24, 2006

Avicena announced that patient enrollment for the first stage of its Phase II ALS clinical trial has been completed by the trial's lead investigator, Paul H. Gordon, M.D., of the Eleanor and Lou Gehrig MDA/ALS Research Center at Columbia University in New York.

In this trial, investigators will assess the efficacy, safety and tolerability of Avicena's proprietary ALS-08 drug candidate in separate combinations with minocycline and celecoxib (a COX-2 inhibitor).

"Completion of patient enrollment for this stage is an important step in the advancement of our clinical drug development program for ALS," said Chief Executive Officer Belinda Tsao-Nivaggioli, Ph.D. "The unique study design allows for an effective assessment of the neuron-protective potential of ALS-08 in combination with two separate agents that have shown to influence different mechanisms of neurodegeneration."

This more efficient study design utilizes a two-stage Phase II protocol to determine a superior combination drug candidate. In the first stage of this six-month, multi-center, double-blinded trial, 86 ALS patients were enrolled. Patients were randomly assigned to one of two combination treatment arms: ALS-08 and minocycline or ALS-08 and celecoxib. Following treatment, investigators will assess the mean difference in ALSFRS-R (revised ALS Functional Rating Scale) between the two treatment arms. If the mean difference between the two treatment groups achieves a pre-defined hurdle rate, the trial is judged to be complete. Only if the pre-defined hurdle rate is not achieved will this Phase II trial continue with a second enrollment stage. For stage two, up to an additional 60 patients would be enrolled and randomly assigned to one of the two treatment arms. Following trial completion, the superior combination therapy will be selected for further study in a Phase III clinical trial.

In addition to the primary ALSFRS-R endpoint, investigators will assess the following secondary outcomes: Safety and Tolerability; Change in Forced Vital Capacity (FVC, percent predicted); Timed Get Up and Go Test (TGUG); Quality of Life; as well as Survival. Investigators will also assess whether the combination drug candidates are safe and well tolerated in conjunction with riluzole, the only FDA-approved ALS drug.