Navigation Links
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 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 Childrens 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 OVATIONs 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.


'/>"/>
Contact: Nikki Nelson
nikki.nelson@edelman.com
312-565-2183
Edelman Public Relations
Source:Eurekalert

Related medicine news :

1. Genetic innovation
2. Biocon To Shift Focus On Innovation To Accelerate Growth
3. IIT Delhi To Display Its Technological Innovations In Open House
4. Patent for Seminal RNAi innovation Cleared in Australia
5. Innovation Needed In The Field Of Diagnostics: Nair
6. A young scientist recognized for biomechanics innovations
7. Blood Safety, Supply, and Innovations Addressed at Conference
8. New Innovation in Clubfoot Treatment
9. Further support for use of statins in Alzheimer’s disease
10. Clinical Impact of Activity and Abdominal Pressure on Pelvic Floor Dysfunction Need to Be Further Analyzed
11. Doctor Accused Of Misdiagnosing 208 Patients: Further Investigation Ordered
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer ... one of the most popular and least understood books in the Holy Scriptures, Revelation. ... descriptions that have baffled scholars for centuries. Many have tossed it off as mere ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains ... possible to save lost souls in the Philippines. “The Journey: From the Mountains to ... dedicated teacher of the Bible. She has taught all ages and currently teaches a ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the technology: , ... to enable prevention of a major side effect of chemotherapy in children. Cisplatin ... patients. For cisplatin, hearing loss is FDA listed on-label as a dose limiting ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... CHICAGO , Oct. 11, 2017  Hill-Rom Holdings, ... its Aspen Surgical facility in Las Piedras, ... surgical scalpels and blades. ... confirmed that the facility sustained minor structural damage, temporary ... Hurricane Maria. Repairs have been completed, manufacturing operations have ...
(Date:10/5/2017)... Oct. 5, 2017  In response to the ... and Maxillofacial Surgeons (AAOMS) released prescribing recommendations that ... be used as a first-line therapy to manage ... Recognizing the value and ... Paper "Opioid Prescribing: Acute and Postoperative Pain Management" ...
(Date:10/2/2017)... 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... and Consulting, LLC , and named its founder as ... in Tennessee , will operate under ... EnvoyHealth,s service offerings for health care partners to include ... "In an interoperable world, technology delivers ...
Breaking Medicine Technology: