Avienca starts clinical trial for ALS drug

Avienca said that the compound has shown neuroprotective effects that may potentially slow the progression of this neurodegenerative disease. Avicena’s phase I study is an open-label, single-center, dose escalation study designed to establish the serum pharmacokinetics of AL-02 at three doses to determine the optimal dose for later stage clinical studies.

In addition to establishing an optimal dose for further study, the trial will also evaluate brain concentration levels of AL-02 pre- and post-treatment via MR spectra measurement.

Amyotrophic lateral sclerosis investigational (ALS) is a neurodegenerative disease that attacks the motor neurons of the brain and spinal cord that are responsible for voluntary muscle movement. As these motor neurons degenerate, their ability to send impulses to the muscle fibers is compromised.

Belinda Tsao-Nivaggioli, CEO of Avicena, said: “The initiation of this trial is an important clinical development milestone within our ALS program. We plan to announce the dose-escalation results in mid-2007, and using the optimal dose identified, we intend to advance AL-02 into additional later-stage clinical trials.”