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Pharmos Completes Preclinical Toxicology And Safety Pharmacology Studies In Oral Cannabinor
Pharmos Corp. (Nasdaq:
PARS) today announced the completion of preclinical toxicology and safety
pharmacology studies of an oral formulation of cannabinor, a synthetic
CB2-selective agonist, to support dosing in humans. The toxicology studies
included maximum tolerated dose (MTD) studies, a 28-day repeat-dose study,
and a cardiovascular safety study in animals.
Results of the repeat-dose, 28-day dose-ranging trial demonstrated that
daily administration of oral cannabinor was safe and well-tolerated with no
serious adverse events or target organ or tissue toxicity. When evaluated
for MTD in animals, oral cannabinor did not present dose-limiting
toxicities when administered at doses expected to be higher than necessary
to produce a therapeutic effect. In addition, the telemetric (wireless data
recording) cardiac safety study demonstrated no treatment-related effect on
blood pressure, heart rate or electrocardiogram (ECG) intervals at doses
expected to be higher than necessary to produce a therapeutic effect. These
data support findings on cardiovascular safety from previous safety and
pharmacology studies where oral cannabinor showed no treatment-related
effect on blood pressure, heart rate or ECG intervals.
"The completion of these MTD, repeat-dose and cardiovascular safety
studies represents an important milestone for oral cannabinor and clears
the way for the initiation of a Phase 1 clinical trial in humans," said
Haim Aviv, Ph.D., Chairman and CEO. Pharmos expects to commence Phase 1
testing of cannabinor in the first quarter of 2007.
About Cannabinor
Cannabinor (formerly referred to as PRS-211,375), the lead synthetic
CB2-selective agonist, is being developed by Pharmos as an analgesic. An
intravenous Phase 2a nociceptive pain trial is underway to assess the
safety and analgesic activity of different cannabinor doses in patients
undergoing 3rd molar extraction and a second intravenous Phase 2a
neuropathic pain trial with cannabinor is underway in subjects undergoing
capsaicin-induced pain. Pharmos expects to complete both trials in early
2007. Oral cannabinor will facilitate clinical development of the compound
for chronic pain conditions, with emphasis on neuropathic pain.
About Pharmos Corporation
Pharmos discovers and develops novel therapeutics to treat a range of
indications with a focus on specific diseases of the nervous system
including disorders of the brain-gut axis (gastrointestinal/irritable bowel
syndrome (IBS)), pain/inflammation, and autoimmune disorders. The Company's
lead product, dextofisopam, has completed Phase 2a testing in IBS, with
positive effect on the 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 Pharmos, to the prospective market
penetration of its drug products, to the development and commercialization
of its pipeline products and to its 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 that 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 Corp.
http://www.pharmoscorp.com
Pharmos completeaza preclinice de toxicologie ºi de siguranþã în studii de farmacologie oral Cannabinor - Pharmos Completes Preclinical Toxicology And Safety Pharmacology Studies In Oral Cannabinor - articole medicale engleza - startsanatate