Pharmos
Receives FDA Fast Track Designation for Dexanabinol
Accelerates New Drug
Application Review for First
Neuroprotective Brain Trauma Product
Iselin
NJ, September 30, 2003 - Pharmos Corporation (Nasdaq:
PARS and Nasdaq Europe: PHRM) today announced the Food
and Drug Administration has granted fast track designation
for dexanabinol for treatment of severe traumatic brain
injury (TBI). In its designation, the FDA acknowledges
TBI as a serious, often life-threatening condition for
which no approved therapies exist, and the potential of
dexanabinol in preventing secondary brain damage due to
its neuroprotective effect. The most significant benefit
to Pharmos is the expedited review of the New Drug Application
for the compound, currently in advanced Phase III clinical
testing.
“Fast
track designation from the FDA for dexanabinol is an important
confirmation of the serious unmet medical needs of TBI
and of the promise dexanabinol holds toward filling those
needs,” said Gad Riesenfeld, Ph.D., President &
COO. “As we near completion of the pivotal trial
of dexanabinol, we look forward to utilizing the means
provided under fast track to shorten dexanabinol’s
time to market, in particular the accelerated regulatory
review. Pharmos will continue to work closely with the
FDA to ensure that its R&D efforts are supportive
of regulatory requirements.”
The
FDA Fast Track programs, codified under the FDA Modernization
Act of 1997, are designed to facilitate the development
and expedite the review of new drugs that are intended
to treat serious or life-threatening conditions, and that
demonstrate the potential to address unmet medical needs.
The programs emphasize the critical nature of close early
communication between the FDA and sponsor to improve the
efficiency of product development.
About TBI
TBI is a leading cause of death and disability among a
predominantly young population as mostly victims of automobile
accidents and the elderly who are prone to falls. 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 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.
The damage following an insult to the brain
occurs in two stages, the first of which is characterized
by the violent shifting of the brain upon initial impact,
in addition to possible skull fractures and bruising.
These primary effects trigger secondary processes in which
neurotoxic chemicals are released in the brain and destroy
healthy cells. Major cellular destruction can also be
brought on by inflammatory processes, and lead to the
most severe and long-lasting damage suffered by those
who survive. Current therapy is limited to emergency supportive
medical care and rehabilitation.
About Dexanabinol
Dexanabinol possesses several characteristics that make
it an ideal candidate to treat TBI. Dexanabinol’s
neuroprotective properties result from its unique combination
of three mechanisms of action. It is an anti-inflammatory
compound that blocks the synthesis of pro-inflammatory
cytokines in the injured brain, significantly slowing
the breakdown of the blood-brain barrier and cellular
death via apoptosis and necrosis. It is also an NMDA receptor
antagonist that prevents the lethal massive influx of
calcium ions into the cells of the injured brain. Finally,
the compound works as an anti-oxidant, acting to protect
the brain by scavenging free radicals that are formed
when the brain sustains an injury. Dexanabinol is the
only compound possessing these multiple mechanisms of
action that has been tested in the treatment of TBI.
Preclinical toxicological studies and Phase
I and Phase II clinical trials demonstrated dexanabinol
to be safe and well tolerated in animals and humans. In
the Phase II clinical program, dexanabinol demonstrated
an improvement in post-injury orientation and memory and
a trend toward efficacy in the primary neurological outcome.
About the TBI Trial
Dexanabinol is currently in an advanced pivotal Phase
III clinical trial to determine safety and efficacy in
severe TBI patients. Total enrollment of approximately
900 multinational TBI patients is planned for the double
blind, randomized, placebo controlled trial. To date more
than 700 patients have been enrolled in almost 80 participating
trauma centers in Europe, Israel, Australia and the U.S,
with completion of enrollment expected in early 2004.
The primary endpoint for the study will be patient outcome
as measured on the Glasgow Outcome Scale – Extended
(GOSE) six months after injury. In order to maximize the
opportunity to measure a drug effect with statistical
significance, enrollment of patients into the study is
carefully controlled by a series of detailed, rigid inclusion
and exclusion criteria.
Patients enrolled in the study are given
a single dose of 150mg dexanabinol or (placebo) vehicle
within six hours after injury. Standard care is provided
to all patients consistent with protocols developed by
the American and European Brain Injury Consortia. Intracranial
pressure is monitored until stabilized at a medically
acceptable level. Patients are evaluated at three and
six months according to GOSE. The goal of the study is
to observe at six months a statistically meaningful difference
in outcome in the number of dexanabinol-treated victims
as compared to the placebo group.
About Pharmos
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 selective CB2 receptor agonist compounds
from Pharmos' proprietary synthetic cannabinoid library
are being studied in pre-clinical programs targeting a
variety of 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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