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 OVATION’s 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 clobazam brings new hope to the children and young adults who suffer from this devastating condition." “For this patient population, there is an urgent need for novel therapies that help manage the disease,” said lead study investigator Joan A. Conry, M.D., Professor of Neurology and Pediatrics in the Department of Neurology at Children’s National Medical Center in Washington, D.C. “We know clobazam has an internationally well established safety and efficacy profile and if the results we have seen thus far are an indication of its potential in patients with LGS in the U.S., we may finally have a treatment that will fill an important unmet need.”
Clobazam is one of the key products in OVATION’s CNS development program. The company is advancing its near-term pipeline on other fronts as well. In July 2007, the company initiated a clinical trial to evaluate a novel intravenous formulation of carbamazepine, a widely used oral antiepileptic drug, in adult patients with epilepsy. The launch of another oral anticonvulsant for rare and refractory epilepsies is anticipated next year.
About Lennox-Gastaut Syndrome
Lennox-Gastaut syndrome is a rare and debilitating form of epilepsy that frequently persists into adulthood . This form of catastrophic epilepsy, characterized by several seizure types, represents up to 10 percent of all childhood epilepsies and onset typically occurs between three and 10 years of age. Drop attacks are frequent in LGS and responsible for most injuries associated with falls. Up to 90 percent of children with LGS are affected by mental retardation and these children commonly experience behavioral and sleep disturbances as well .About Clobazam As a 1,5-benzodiazepene, clobazam has a distinctive chemical structure with associated unique properties when compared with other currently available benzodiazepines. It was initially developed to decrease the adverse effects seen with 1,4-benzodiazepines while still maintaining efficacy. Clobazam in animal models works both by intensifying gamma-aminobutyric acid (GABA)-mediated inhibitory effects and by increasing activity of glutamate transporters.
Currently, clobazam is widely available worldwide with approvals in more than 100 countries for various uses in both children and adults, including the treatment of epilepsy and anxiety. Though not currently approved for any use in the U.S., OVATION has undertaken a clinical development program to gain U.S. Food and Drug Administration (FDA) approval for clobazam as adjunctive treatment for patients with LGS.
About OVATION Pharmaceuticals
OVATION is a fast growing biopharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients’ lives through its focus on central nervous system (CNS), hematology/oncology, and hospital-based therapies. The four new product launches the company expects over the next five years will be fueled by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 “Pharma Company of the Year” award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at www.ovationpharma.com. Beaumanoir A, Blume, W. The Lennox-Gastaut Syndrome- Symptomatology During the Seizure Disorder. In: J. Roger MB, C. Dravet, P. Genton, C.A. Tassinari, & P. Wolf, ed. Epileptic Syndromes in Infancy, Childhood, and Adolescence 3rd ed. London: John Libbey & Co., Ltd. 2002:113-135.Markand ON. Lennox-Gastaut syndrome (childhood epileptic encephalopathy). J Clin Neurophysiol. 2003;20:426-441.
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