Pharmos Corporation
(Nasdaq: PARS) announced today it has completed its initial analysis of
data from a recently completed Phase 1 study of its proprietary
NanoEmulsion topical drug delivery technology formulated with diclofenac.
Diclofenac is an approved and widely-used non-steroidal anti-inflammatory
drug (NSAID). The analysis of the data indicates the formulation was safe
and well tolerated with no severe or serious adverse events; subject
compliance with the 14-day treatment period was excellent. In addition, the
pharmacokinetic analysis demonstrated low systemic exposure of diclofenac
with no drug accumulation following repeated daily administrations. These
pharmacokinetic results in humans confirm the preclinical data previously
obtained in animals showing reduced systemic plasma levels following
topical administration of the NanoEmulsion cream.
Alan L. Rubino, President and COO, said, "Based on strong market demand
for safe and effective delivery vehicles for medications, and analgesics in
particular, we feel our NanoEmulsion technology may offer new value and be
a timely therapeutic alternative in the US and other major markets given
current treatment voids and patient needs in this disease category."
The single-center, open label, multiple-dose, topical application study
included 16 healthy male and female volunteers. The trial evaluated the
safety, tolerability and pharmacokinetic profile of 3% NanoEmulsion
diclofenac topical cream following 14 days of three daily administrations
and was conducted at Harrison Clinical Research in Munich, Germany.
Pharmos is developing the NanoEmulsion topical diclofenac cream as a
potential treatment for Osteoarthritis (OA) pain. OA is a painful condition
affecting more than 30 million people in the US, and is the most frequent
cause of physical disability among adults, mainly elderly. Topical
diclofenac is also being considered as treatment for soft tissue injuries,
sprains and strains. It is estimated that 20% of OA patients are not
receiving treatment, mainly due to gastrointestinal side effects of oral
NSAIDs and cardiovascular risk of COX-2 inhibitors. A topical NSAID
offering adequate pain relief targeted to the site of injury with an
improved safety profile could become a treatment alternative for these
patients. In the US, there are no approved topical NSAIDs for the treatment
of OA.
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.
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. Pharmos owns a family of patents covering novel
NanoEmulsion formulations as vehicles for localized delivery of lipophilic
drugs. A topical application of the nanotechnology has already demonstrated
excellent targeted delivery of lipophilic drugs to muscle and joints in
animal models.
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 also tested in a
previous Phase 1 human skin irritancy study involving 25 healthy
volunteers. No irritation or allergic responses were observed after topical
application.
About Pharmos Corporation
Pharmos discovers and develops novel therapeutics to treat a range of
indications including specific diseases of the nervous system such as
disorders of the brain-gut axis (GI/IBS), pain/inflammation, and autoimmune
disorders. The Company's lead product, dextofisopam, has completed Phase 2a
testing in IBS, a common GI disorder particularly prevalent in women, with
positive effect on primary efficacy endpoint (n=141, p=0.033). The Company
plans a Phase 2b study of dextofisopam for the treatment of IBS in 2007.
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 undergoing Phase 2a testing in
pain. Other compounds in Pharmos' pipeline are in clinical and pre-clinical
studies targeting pain, multiple sclerosis, rheumatoid arthritis and other
disorders.
Safe Harbor Statement
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.
Pharmos Corporation
pharmoscorp
View drug information on Ketoprofen.
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