Pharmos
Expands International Head Trauma Study of Dexanabinol
into the U.S.
Iselin,
NJ, February 18, 2003
- Pharmos Corporation (Nasdaq: PARS and Nasdaq Europe:
PHRM) 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. Other 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.
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