Printer Friendly
The Free Library
14,505,384 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Ovation Further Advances Development Pipeline with New Phase III Epilepsy Study.


- Clobazam Study Marks Another Milestone in Robust CNS See Continuous net settlement.

CNS

See continuous net settlement (CNS).
 Portfolio -

DEERFIELD, Ill. -- OVATION Pharmaceuticals, Inc. announced the initiation of a pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  evaluating clobazam, a unique 1,5 benzodiazapine with significant anticonvulsant anticonvulsant /an·ti·con·vul·sant/ (-kon-vul´sant) inhibiting convulsions, or an agent that does this.

an·ti·con·vul·sant
n.
A drug that prevents or relieves convulsions.
 properties, as adjunctive treatment for patients with Lennox-Gastaut syndrome (LGS LGS Laser Guide Star
LGS Lennox-Gastaut Syndrome
LGS Leaky Gut Syndrome
LGS Langer-Giedion Syndrome
LGS Light Gauge Steel (steel frame construction system)
LGS Looking Glass Studios (game development company) 
), 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 a·ton·ic
adj.
Relating to, caused by, or exhibiting lack of muscle tone.



ato·nic
) seizures compared to baseline. Drop seizures are the most debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 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 dev·as·tate  
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.

2. To overwhelm; confound; stun: was devastated by the rude remark.
 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 This article or section is written like an .
Please help [ rewrite this article] from a neutral point of view.
Mark blatant advertising for , using .
 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 carbamazepine /car·ba·maz·e·pine/ (kahr?bah-maz´e-pen) an anticonvulsant and analgesic used in the treatment of pain associated with trigeminal neuralgia and in epilepsy manifested by certain types of seizures. , 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 adulthood1 . This form of catastrophic epilepsy, characterized by several seizure types, represents up to 10 percent of all childhood epilepsies2 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 well3 .

About Clobazam

As a 1,5-benzodiazepene, clobazam has a distinctive chemical structure with associated unique properties when compared with other currently available benzodiazepines Benzodiazepines Definition

Benzodiazepines are medicines that help relieve nervousness, tension, and other symptoms by slowing the central nervous system.
Purpose

Benzodiazepines are a type of antianxiety drugs.
. 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 GABA ?.

GABA
abbr.
gamma-aminobutyric acid


GABA (gamma-aminobutyric acid)
A neurotransmitter that slows down the activity of nerve cells in the brain.
)-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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) 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.

1 Beaumanoir A, Blume, W. The Lennox-Gastaut Syndrome- Symptomatology symptomatology /symp·to·ma·tol·o·gy/ (simp?to-mah-tol´ah-je)
1. the branch of medicine dealing with symptoms.

2. the combined symptoms of a disease.


symp·to·ma·tol·o·gy
n.
 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.

2 Markand ON. Lennox-Gastaut syndrome (childhood epileptic encephalopathy encephalopathy /en·ceph·a·lop·a·thy/ (en-sef?ah-lop´ah-the) any degenerative brain disease.

AIDS encephalopathy  HIV e.

anoxic encephalopathy  hypoxic e.
). J Clin Neurophysiol. 2003;20:426-441.

3 Crumrine PK. Lennox-Gastaut syndrome. J Child Neurol. 2002;17 Suppl 1:S70-75.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Sep 4, 2007
Words:908
Previous Article:Transcontinental Direct's Mail-Gard Division Achieves Level 2 Compliance with Payment Card Industry Data Security Standard.
Next Article:New Hampshire Residents Walking to End Alzheimer's on September 15th.
Topics:



Related Articles
New fields of architecture: Hal Foster on Zaha Hadid.
"Modernism: Designing a New World 1914-1939"; Victoria & Albert Museum, London.
Pfizer's problems hurting MannKind: billionaire Al Mann may dig deep to save company.(BIOTECH)
Calendar.(Data Bank)(Calendar)
Market diary.(THE LABJ STOCK INDEX: TRACKING 200 SELECTED LOS ANGELES COUNTY-BASED COMPANIES)
Market summary.(THE LABJ STOCK INDEX: TRACKING 200 SELECTED LOS ANGELES COUNTY-BASED COMPANIES)
Torrance sale.(REAL ESTATE)
New PCIe bridge-based riser cards allow connection to PCI-X cards.
Promises, promises: what ever happened to the 18-month product cycle and 10-day vehicle delivery schedules some industry insiders had been predicting...
AWI secures $92,000 matching grant to develop skill standards.(TRENDS & NEWS)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles