Pharmos Initiates Phase I Trial of CB2-Selective Drug Candidate Cannabinor

Sep 06, 2005, 01:00 ET from Pharmos Corporation

    ISELIN, N.J., Sept. 6 /PRNewswire-FirstCall/ -- Pharmos Corporation
 (Nasdaq:   PARS) announced today that it has initiated a Phase I trial with
 cannabinor, a CB2-selective synthetic cannabinoid drug candidate. The study
 will assess the safety, tolerability and pharmacokinetics of cannabinor in
 healthy volunteers.
     The trial will enroll up to 48 healthy male subjects in a randomized,
 double blind, placebo controlled, intravenous, escalating single dose study.
 The trial is being conducted at the Harrison Clinical Research Unit in Munich,
 Germany with clinical trial material manufactured in the Company's GMP pilot
     It is expected that the Phase I cannabinor trial will be completed and the
 results analyzed by year-end 2005. If the trial results demonstrate that an
 adequate dose is safe and well-tolerated, Phase II trials in pain indications
 are planned for early 2006. Contingent clinical protocols are being developed
 for several potential Phase II trials including neuropathic pain, post-
 surgical pain and other indications. The final decisions regarding indications
 to be examined in the Phase II program will await analysis of the Phase I
     "Initiating clinical development of compounds that work preferentially on
 the CB2 receptor is an important milestone for the Company. We hope that
 cannabinor will become an anti-pain drug that addresses significant unmet
 patient needs," said Haim Aviv, Ph.D., Chairman and CEO. He continued,
 "Pharmos continues to build and leverage its unique expertise with synthetic
 cannabinoid compounds. We believe this class of compounds has great promise
 for a variety of applications in human health as CB1 and CB2 cannabinoid
 receptors in the brain and immune system play an integral role in nociception,
 inflammation and autoimmunity."
     Howard Grossberg, M.D., Vice President of Drug Development, added, "The
 scientific community has suggested for years that substances similar to or
 derived from marijuana, known as cannabinoids, could treat pain. Now, careful
 studies show that cannabinoids directly interfere with pain signaling in the
 nervous system. Compounds that display high affinity for the CB2 receptor may
 offer avenues for harnessing the analgesic effect of CB-receptor agonists
 while avoiding the psychotropic and other adverse events seen with cannabinoid
     In preclinical studies, cannabinor has been shown to be effective in
 numerous experiments involving more than a dozen different animal models of
 various types of pain and autoimmune diseases. In models of noxious,
 neuropathic, inflammatory, visceral, and post-surgical pain, the analgesic
 activity of cannabinor was comparable or superior to reference agents tested
 including morphine and a variety of NSAIDs. Involvement of CB2 receptors in
 the drug candidate's mechanism of action is supported by observations that
 specific CB2 antagonists modulate cannabinor's analgesic and anti-inflammatory
     Cannabinor and other compounds from Pharmos' proprietary CB2-selective
 platform have demonstrated significant efficacy in animal models of
 immunologic dysfunction, including multiple sclerosis, rheumatoid arthritis,
 and inflammatory bowel disease. There is increasing evidence that cannabinoids
 have a number of useful functions in autoimmune disease including altering the
 balance between TH1 and TH2 lymphocytes in a favorable fashion as well as
 modulation of macrophage function and activation of MAP kinase. After
 anticipated Phase II studies in pain are underway, a decision will be made
 whether to expand testing of cannabinor or to advance another candidate from
 the Company's pipeline into clinical development for the treatment of
 autoimmune disease.
     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 undergoing Phase I safety studies
 and, if successful, will enter Phase II testing in pain indications around
 year-end or early 2006. From the dextrocannabinoid family, the neuroprotective
 drug candidate dexanabinol 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.
     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.

SOURCE Pharmos Corporation