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Ovation further advances development pipeline with new phase III epilepsy study
Date:9/4/2007

DEERFIELD, Ill., September 4, 2007 OVATION Pharmaceuticals, Inc. announced the initiation of a pivotal Phase III clinical trial evaluating clobazam, a unique 1,5 benzodiazapine with significant anticonvulsant properties, as adjunctive treatment for patients with Lennox-Gastaut syndrome (LGS), one of the most severe forms of childhood epilepsy that frequently persists into adulthood. In previous studies clobazam was shown to be well tolerated in patients with LGS and met the primary endpoint in a Phase II dose range finding study of a significant reduction in drop (or atonic) seizures compared to baseline. Drop seizures are the most debilitating of the LGS seizures types, which can result in severe trauma to the brain and body. This latest study demonstrates OVATIONs progress in advancing its central nervous system (CNS) development pipeline.

LGS, like many catastrophic epilepsies, can be both devastating and overwhelming for patients and their families, and clobazam may offer improved seizure control for patients affected by this condition, said Stephen D. Collins M.D., Ph.D., Chief Scientific Officer and Vice President of Clinical Affairs, Ovation Pharmaceuticals. OVATION remains committed to exploring new treatment options for epilepsy, particularly where current treatment needs are not fully addressed.

The Phase III study is designed to evaluate the safety and efficacy of clobazam in the reduction of atonic seizures at three dose levels in children and adults (ages 2-60 years) with LGS. The company plans to recruit patients with LGS at approximately 60-65 sites. The double-blind, placebo-controlled study will last up to 23 weeks. For more information and study locations, please visit www.clinicaltrials.gov.

"LGS is one of the most severe forms of epilepsy and we desperately need new treatment options," said Eric R. Hargis, President and CEO of the Epilepsy Foundation. "We hope that the Phase III study shows great results and that
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Contact: Nikki Nelson
nikki.nelson@edelman.com
312-565-2183
Edelman Public Relations
Source:Eurekalert

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