Feb. 18, 2003
Pharmos Corporation today announced the FDA has accepted its Investigational New Drug (IND) application for the clinical development of dexanabinol for the treatment of traumatic brain injury (TBI) in the U.S. IND acceptance enables the Company to proceed with its plans to recruit U.S. neurotrauma centers into its ongoing international pivotal Phase III study. Pharmos is cooperating with the American Brain Injury Consortium in selecting the U.S. centers. Total enrollment of approximately 860 patients is anticipated to be completed in 2003 and to date, more than 500 patients have been enrolled in over 60 centers throughout 11 European countries, Israel and Australia.
"Expanding our study of dexanabinol for head injury into the U.S. is a very important milestone in this program," said Dr. Gad Riesenfeld, President and C.O.O. "Subject to the results of the study, we intend to submit the data of the combined international and U.S. study to the FDA and to other international regulatory agencies for worldwide marketing approvals. If approved, dexanabinol would be the first pharmaceutical product for head injury."
TBI is a leading cause of death and disability in industrialized societies. Annually, within the U.S., there are about 1.5 million head injuries, roughly 300,000 hospital admissions for head trauma, nearly 52,000 deaths and approximately 80,000 cases of severe long-term disability. The annual cost of acute care and rehabilitation in the U.S. for new cases is estimated to be as high as $10 billion. At present, there are an estimated 5.3 million Americans currently living with disabilities resulting from TBI. The annual market potential for the first FDA-approved drug treating TBI victims in the U.S. is estimated to be over $500 million. The worldwide market potential may exceed $1 billion.
Pharmos discovers, develops, and commercializes novel therapeutics to treat a range of indications, in particular neurological and inflammation- based disorders. The Company's first neuroprotective product is dexanabinol, a synthetic tricyclic non-psychotropic dextrocannabinoid, currently undergoing clinical testing as a treatment for TBI and as a preventive agent against post-surgical cognitive impairment. ther dextrocannabinoid compounds and CB2 receptor agonist compounds from Pharmos' proprietary synthetic cannabinoid library are being studied in pre-clinical programs targeting stroke, pain, multiple sclerosis and other disorders.
Statements made in this press release related to the business outlook and future financial performance of the Company, to the prospective market penetration of its drug products, to the development and commercialization of the Company's pipeline products and to the Company's expectations in connection with any future event, condition, performance or other matter, are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties which may cause results to differ materially from those set forth in these statements. Additional economic, competitive, governmental, technological, marketing and other factors identified in Pharmos' filings with the Securities and Exchange Commission could affect such results.
SOURCE Pharmos Corporation Web Site: http://www.pharmoscorp.com
Copyright © 1996-2002 PR Newswire Association LLC