Pharmos
Files Investigational New Drug Application for a Phase
III Study of Dexanabinol to Treat TBI
Company
Seeks to Expand its Phase III Study into the US
Iselin,
NJ, October 21, 2002 - Pharmos Corporation (Nasdaq:
PARS and Nasdaq Europe: PHRM) today announced the submission
to the FDA of an Investigational New Drug (IND) application
to begin U.S. patient enrollment in its pivotal Phase
III trial of dexanabinol for the treatment of traumatic
brain injury (TBI). Subject to successful completion of
FDA review, the Company estimates a total of up to 30
U.S. trauma centers will join the 60 centers in Europe,
Israel and Australia already participating in the study.
More than 400 patients have been enrolled in the trial
to date.
“There
is a tremendous unmet need in the treatment of TBI, as
only supportive care is currently available to patients,”
said Dr. Gad Riesenfeld, President and C.O.O. “Expanding
into the U.S. will accelerate patient enrollment in the
pivotal study, and thereby move us more quickly toward
our goal of completing dexanabinol’s clinical development.”
Dr. Nadim Kassem, Vice President of Clinical and Regulatory
Affairs, added, “We designed our large-scale study of
severe TBI patients to address the challenges inherent
in developing a therapeutic product to treat this very
serious indication.”
TBI
is a leading cause of death and disability among a predominantly
young population, mostly victims of accidents. According
to the U.S. Centers for Disease Control, about 1.5 million
Americans annually sustain an injury to the brain. The
incidence of TBI is about eight times the number of people
diagnosed with breast cancer and 34 times the number of
new cases of HIV/AIDS each year. An estimated 5.3 million
Americans (2% of the population) currently live with disabilities
resulting from TBI, and about one in four adults with
TBI are unable to return to work one year after their
injury. Hospitalization of TBI costs the nation upwards
of $56 billion each year, including decreased tax revenues
and increased welfare costs that result when those injured,
or their caregivers, are unable to return to work. No
effective drug therapy to treat the effects of TBI is
approved in the U.S. or internationally, leaving TBI a
totally unserved market worldwide.
Pharmos
is lending its support toward improving the understanding
of TBI and its treatment through a sponsorship at the
first joint symposium of the National and International
Neurotrauma Societies (N-INTS), taking place October 27
– November 1, 2002 in Tampa, Florida. Pharmos’ presence
as sponsor will be most visible during the October 28
session, “TBI: History and Challenges for the Future,”
presented by Professor Graham Teasdale, M.D., Chairman
of the European Brain Injury Consortium. More information
on N-INTS can be found at http://www.neurotrauma2002.org/.
More information on TBI can be found at the U.S. Centers
for Disease Control and Prevention, National Center for
Injury Prevention and Control website: http://www.cdc.gov/ncipc/didop/tbi.htm,
and the Brain Injury Association, Inc. website: http://www.biausa.org/.
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 tricyclic 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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