Teva Provides Update On Talampanel For The Treatment Of Amyotrophic Lateral Sclerosis (ALS)

Main Category: Muscular Dystrophy / ALS
Article Date: 18 May 2010 - 20:00 PDT

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Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced results from the Phase II ALSTAR trial. The trial was designed to assess efficacy, safety and tolerability of Talampanel (a selective AMPA antagonist) in reducing disease-related functional deterioration in Amyotrophic Lateral Sclerosis (ALS) patients. Results indicate that while Talampanel was safe for ALS patients, the study did not meet its primary endpoint.

"Despite our hopes to advance the treatment of this debilitating disease, Talampanel did not succeed in demonstrating the required efficacy, although safety was established," said Moshe Manor, Teva's Group Vice President, Global Branded Products. "Broadening our innovative pipeline - through internal R&D, licensing and other business development activities - is part of our long term strategy. This outcome has no impact on our 2015 innovative goal. We will continue to pursue the development of innovative treatments, focused on the therapeutic areas of neurology, autoimmunity and oncology."

About the Study

The multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase II study was conducted in 25 centers across US, Canada, Europe and Israel and included 559 patients with ALS. Patients were randomized to receive either Talampanel 25mg three times daily, or Talampanel 50mg three times daily or placebo orally for a period of 52 weeks. All patients enrolled in the trial were allowed to use riluzole (83 percent of patients were on riluzole at the beginning of trial) in combination with Talampanel. The primary outcome measure was change from baseline in the revised ALS Functional Rating Scale (ALSFRS-R), a scale for monitoring progression of disability in ALS patients.

About Talampanel

Talampanel is an orally active antagonist of the alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) neuronal excitatory glutamate receptor.

About Amyotrophic Lateral Sclerosis (ALS)

ALS, also known as "Lou Gehrig's disease", is a degenerative motor neuron disease that leads to paralysis and ultimately, to death, usually within 3-5 years from disease onset. The cause of death is most often due to respiratory failure. Progressive symptoms of the disease include muscle weakness in limbs, muscle twitching (fasciculation) and cramping, speech impediments, difficulty swallowing and respiratory impairment. Over 10,000 people in the U.S. and Europe are diagnosed with ALS each year. It is estimated that at least 50,000 people worldwide have the disease at any given time.

Source
Teva Pharmaceutical Industries Ltd

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