ISELIN, N.J., July 6 /PRNewswire-FirstCall/ -- Pharmos Corporation ( NASDAQ:PARS )
announced today the initiation of a clinical program to commercialize its proprietary
NanoEmulsion drug delivery technology. The Company plans to initiate a Phase
I/II feasibility clinical trial before yearend. The study will evaluate safety,
pharmacokinetics and the analgesic effect of an approved non-steroidal anti-inflammatory
drug (NSAID) formulated in its NanoEmulsion in patients with osteoarthritic
pain in the knee.
Pharmos previously invented and owns a family of
patents covering novel NanoEmulsion formulations
as vehicles for lipophilic drugs. A topical application
of the nanotechnology has already demonstrated excellent
targeted delivery of lipophilic drugs to muscle and
joints in animal models.
"As we continue our efforts to acquire clinical-stage
compounds, our new initiative broadens our development
pipeline with programs designed to shorten development
timelines and reduce technical risk of products that
have significant market potential," said Haim Aviv,
Ph.D. Chairman & CEO of Pharmos.
Howard Grossberg, M.D., Vice President, Drug Development
added, "Safety concerns and the recent withdrawal
of COX-2 inhibitors from the market has left large
numbers of patients without adequate treatment of
their pain. We believe an effective topical administration
of safe and effective analgesics can help these patients
significantly." Dr. Grossberg continued, "This new
initiative will develop our proprietary topical nanodelivery
system on a parallel path to our existing clinical
program for the development of novel, small molecule
analgesic agents in order to enhance their potential
value by providing for multiple routes of administration.
That program is on track to commence a Phase I trial
during this quarter for systemic delivery of cannabinor,
our lead CB2-selective cannabinoid which demonstrates
both analgesic and immunomodulatory properties, to
treat moderate to severe pain indications such as
neuropathic pain and post-operative pain."
Topical application of drugs directly to pathological
sites offers potential advantages over systemic delivery
by producing high drug concentration in the affected
tissue while avoiding unwanted side-effects due to
high systemic drug levels. Topical preparations of
NSAIDs are commonly used as analgesics and anti-inflammatory
agents to treat various disorders such as arthropathies
and myalgias. Many topical formulations employ chemical
penetration enhancers to improve dermal penetration
of drugs. Chemical enhancers, which are usually organic
solvents, may cause skin irritation and sensitization.
An advantage of Pharmos' NanoEmulsion is that it
is composed of natural lipids and oils designed to
minimize irritation.
Preclinical data using a paw edema animal model
showed enhanced anti-inflammatory activity with NSAIDs
encapsulated in NanoEmulsion creams compared to commercial
formulations. Pharmacokinetic studies using NanoEmulsion
topical creams containing radiolabeled diclofenac
and ketoprofen were performed to assess drug penetration
through skin and to determine local tissue (muscle
and joint) and plasma levels of drugs following topical
administration. Compared to oral administration,
diclofenac and ketoprofen administered via NanoEmulsion
topical creams demonstrated 4-6 fold lower drug concentration
in plasma, 60-80 fold more drug in muscle tissue,
and about 9 fold more drug in joints.
The Company's NanoEmulsion containing diclofenac
was tested in a Phase I human skin irritancy study
involving 25 healthy volunteers. No irritation or
allergic responses were observed after topical application.
Pharmos' NanoEmulsion technology consists of an
efficient solvent-free topical vehicle based on drug
entrapment in stable, submicron particles of oil-in-water
emulsions with a mean droplet size between 100 and
200 nm that are uniformly dispersed in an aqueous
phase. One of the unique characteristics of the NanoEmulsion
technology is the relatively high percentage of total
particle volume occupied by the internal hydrophobic
oil core of the droplets. This provides high solubilization
capacity for lipophilic compounds compared to other
lipoidal vehicles such as liposomes. Viscosity-imparting
agents are used for NanoEmulsion thickening to produce
creams with the desired semisolid consistency for
application to the skin.
The skin penetrative properties of the solvent-free
NanoEmulsion delivery technology and its low irritancy
make this novel topical nanovehicle a promising candidate
for effective transcutaneous delivery of lipophilic
drugs. The NanoEmulsion technology is one of several
proprietary lipid-based drug delivery nanotechnologies
developed by Pharmos and covered by a portfolio of
patents supporting a wide range of drugs and medical
applications.
Pharmos discovers and develops novel therapeutics
to treat a range of indications, in particular neurological
and inflammatory disorders. The Company's core proprietary
technology platform focuses on discovery and development
of synthetic cannabinoid compounds. Cannabinor, the
lead CB2- selective receptor agonist candidate, is
scheduled to begin Phase I safety studies in the
third quarter of 2005 and, if successful, enter Phase
II testing in pain indications around yearend or
early 2006. From the dextrocannabinoid family, the
neuroprotective drug candidate dexanabinol recently
completed a Phase IIa trial as a preventive agent
against post- surgical cognitive impairment. Other
compounds from Pharmos' proprietary synthetic cannabinoid
library are in pre-clinical studies targeting pain,
multiple sclerosis, rheumatoid arthritis and other
disorders. The Company's NanoEmulsion drug delivery
system is in clinical-stage development for topical
application of analgesic and anti-inflammatory agents.
Pharmos' filings
with the Securities and Exchange Commission could
affect such results.
Source: Pharmos Corporation
CONTACT: Gale Smith of Pharmos U.S., +1-732-452-9556,
or Irit Kopelov of
Pharmos Israel, +972-8-940-9679; or John Quirk, Investors, +1-646-536-7029,
or
Janine McCargo, Media, +1-646-536-7033, both of The Ruth Group, Inc. for
Pharmos Corporation
Web site: http://www.pharmoscorp.com/
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