Pharmos’
Pivotal Study of Dexanabinol for Traumatic Brain Injury
Commences in Europe
Iselin
NJ, and San Francisco January 10, 2001 – Pharmos
Corporation (Nasdaq: PARS and Easdaq: PHRM) announced
today that its pivotal clinical trial of dexanabinol for
severe traumatic brain injury (TBI) has commenced in Europe.
TBI is a leading cause of death and disability among a
predominantly young population, mostly victims of automobile
accidents. Currently, there is no approved drug that protects
the brain from the damage following a traumatic brain
insult.
Lawrence
Marshall, M.D., Professor and Chair of the Division of
Neurological Surgery at the University of California,
San Diego Medical Center, stated, “There is a tremendous
need for an effective therapy for these patients. The
Phase II data for dexanabinol were among the most favorable
we have ever seen for a TBI drug. The two most impressive
aspects were the short-term results, in which there was
a universal reduction in intracranial pressure; and the
long-term results, in which there was a substantial improvement
of neuro-cognitive outcome in treated patients at six
months.”
The
purpose of the pivotal Phase III study is to determine
the safety and efficacy of dexanabinol in severe TBI patients.
Approximately 40 centers in Europe and 30 in the U.S.
are expected to participate in the study. European countries
participating in the study include Finland, France, Germany,
the Netherlands, Italy, Spain, Belgium and the U.K., along
with Israel. The Company plans to begin the U.S. arm of
the trial later this year, and expects total study enrollment
of about 860 patients. Pharmos is collaborating with the
European Brain Injury Consortium (EBIC) and the American
Brain Injury Consortium in a number of areas, including
recruitment efforts with trauma centers.
Graham
Teasdale, M.D., Chairman of EBIC and Professor of Neurosurgery
at Southern General Hospital in Glasgow, Scotland, said,
“This study is of great interest to us. In a clinical
sense, the protocol design is optimal by virtue of its
encompassing the most current findings on severe brain
injury, an area where EBIC was able to provide much guidance
from its extensive experience in research into the management
of head injuries.”
Speaking
at the Chase H&Q 19th Annual Healthcare conference
in San Francisco, Dr. Gad Riesenfeld, President and COO
of Pharmos, commented, “We see a very promising clinical
and commercial opportunity in the development of dexanabinol.
TBI is a large, under-served market, in which physicians
and surgeons are enthusiastically seeking new therapeutics.
Our clinical development program has proceeded efficiently
with careful design and input from experts worldwide.
This pivotal trial is built on a firm foundation of both
encouraging Phase II data and favorable attributes of
the drug.”
Inclusion
criteria of the TBI patients enrolled in the study include
scoring 2-5 on the Motor Glasgow Coma Scale and at least
2 on the CT scan scale with visible parenchymal damage.
A single intravenous dose of either placebo or 150 mg
of dexanabinol within six hours from injury will be administered
to patients, who will be continuously monitored while
in the hospital until reaching stabilized conditions.
Neurological outcome will be evaluated periodically and
at six months using the Extended Glasgow Outcome Scale.
TBI
is a leading cause of death and disability among a predominately
young male population, mostly victims of automobile accidents.
Estimates of the occurrence of the indication run as high
as 10 million cases per year worldwide. Annually, within
the U.S., head trauma is the cause of about two million
emergency room visits, roughly 475,000 hospital admissions,
nearly 52,000 deaths and approximately 80,000 cases of
severe long-term disability. The estimated annual TBI
market is over $500 million each in the U.S. and Europe.
Background
on Dexanabinol
Dexanabinol
possesses several characteristics that make it an ideal
candidate to treat TBI, and the clinical trial has been
designed to exploit these strengths. First, dexanabinol
appears to have a relatively long therapeutic window that
may result from its unique combination of certain potent
neuro-protective mechanisms that work at different intervals
from the time of insult. Second, toxicological studies
and Phase I and Phase II clinical trials demonstrated
dexanabinol to be safe and well tolerated. Third, the
intravenous administration of a single 150 mg dose safely
results in the most effective levels of the drug in the
blood. Finally, dexanabinol demonstrated a trend of efficacy
in neurological outcome in Phase II clinical development.
Pharmos notes that its clinical protocol strongly adheres
to and reflects all its pre-clinical and clinical findings
as well as the experience of others.
Dexanabinol’s
neuro-protective properties result from its unique combination
of three critical mechanisms of action. It is an anti-oxidant,
acting to protect the brain by scavenging free radicals
that are formed when the brain sustains an injury. It
is also an anti-inflammatory compound that may block the
synthesis of pro-inflammatory cytokines in the injured
brain, significantly slowing the breakdown of the blood-brain
barrier and in the development of apoptosis and necrosis.
Dexanabinol is also a weak and safe NMDA antagonist that
prevents the lethal massive influx of calcium ions into
the cells of the injured brain. Dexanabinol is the only
compound demonstrating these multiple mechanisms of action
that has been tested in the treatment of TBI.
Pharmos
has broad neurological and neuro-vascular inflammation-based
R&D programs based on its platform of novel synthetic
non-psychotic cannabinoid compounds. The compounds are
in various stages of pre-clinical testing for stroke,
Multiple Sclerosis, pain and other neuro-inflammatory
related indications.
Pharmos
Corporation discovers and develops novel therapeutics
to treat a range of inflammatory and neurological disorders,
such as traumatic brain injury and stroke. The Company
has an extensive portfolio of drug candidates under development,
as well as discovery, pre-clinical and clinical capabilities.
Statements
made in this press release related to operational expectations
and projections of the Company and to the continued market
penetration of its drug products 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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