ISELIN, N.J. and SAN FRANCISCO, Jan. 10 /PRNewswire/ -- Pharmos Corporation (Nasdaq: PARS; Easdaq: PHRM) announced today that its pivotal clinical trial of dexanabinol for severe traumatic brain injury (TBI) has commenced in Europe. TBI is a leading cause of death and disability among a predominantly young population, mostly victims of automobile accidents. Currently, there is no approved drug that protects the brain from the damage following a traumatic brain insult.
Lawrence Marshall, M.D., Professor and Chair of the Division of Neurological Surgery at the University of California, San Diego Medical Center, stated, "There is a tremendous need for an effective therapy for these patients. The Phase II data for dexanabinol were among the most favorable we have ever seen for a TBI drug. The two most impressive aspects were the short-term results, in which there was a universal reduction in intracranial pressure; and the long-term results, in which there was a substantial improvement of neuro-cognitive outcome in treated patients at six months."
The purpose of the pivotal Phase III study is to determine the safety and efficacy of dexanabinol in severe TBI patients. Approximately 40 centers in Europe and 30 in the U.S. are expected to participate in the study. European countries participating in the study include Finland, France, Germany, the Netherlands, Italy, Spain, Belgium and the U.K., along with Israel. The Company plans to begin the U.S. arm of the trial later this year, and expects total study enrollment of about 860 patients. Pharmos is collaborating with the European Brain Injury Consortium (EBIC) and the American Brain Injury Consortium in a number of areas, including recruitment efforts with trauma centers.
Graham Teasdale, M.D., Chairman of EBIC and Professor of Neurosurgery at Southern General Hospital in Glasgow, Scotland, said, "This study is of great interest to us. In a clinical sense, the protocol design is optimal by virtue of its encompassing the most current findings on severe brain injury, an area where EBIC was able to provide much guidance from its extensive experience in research into the management of head injuries."
Speaking at the Chase H&Q 19th Annual Healthcare conference in San Francisco, Dr. Gad Riesenfeld, President and COO of Pharmos, commented, "We see a very promising clinical and commercial opportunity in the development of dexanabinol. TBI is a large, under-served market, in which physicians and surgeons are enthusiastically seeking new therapeutics. Our clinical development program has proceeded efficiently with careful design and input from experts worldwide. This pivotal trial is built on a firm foundation of both encouraging Phase II data and favorable attributes of the drug."
Inclusion criteria of the TBI patients enrolled in the study include scoring 2-5 on the Motor Glasgow Coma Scale and at least 2 on the CT scan scale with visible parenchymal damage. A single intravenous dose of either placebo or 150 mg of dexanabinol within six hours from injury will be administered to patients, who will be continuously monitored while in the hospital until reaching stabilized conditions. Neurological outcome will be evaluated periodically and at six months using the Extended Glasgow Outcome Scale.
TBI is a leading cause of death and disability among a predominately young male population, mostly victims of automobile accidents. Estimates of the occurrence of the indication run as high as 10 million cases per year worldwide. Annually, within the U.S., head trauma is the cause of about two million emergency room visits, roughly 475,000 hospital admissions, nearly 52,000 deaths and approximately 80,000 cases of severe long-term disability. The estimated annual TBI market is over $500 million each in the U.S. and Europe.
Background on Dexanabinol
Dexanabinol possesses several characteristics that make it an ideal candidate to treat TBI, and the clinical trial has been designed to exploit these strengths. First, dexanabinol appears to have a relatively long therapeutic window that may result from its unique combination of certain potent neuro-protective mechanisms that work at different intervals from the time of insult. Second, toxicological studies and Phase I and Phase II clinical trials demonstrated dexanabinol to be safe and well tolerated. Third, the intravenous administration of a single 150 mg dose safely results in the most effective levels of the drug in the blood. Finally, dexanabinol demonstrated a trend of efficacy in neurological outcome in Phase II clinical development. Pharmos notes that its clinical protocol strongly adheres to and reflects all its pre-clinical and clinical findings as well as the experience of others.
Dexanabinol's neuro-protective properties result from its unique combination of three critical mechanisms of action. It is an anti-oxidant, acting to protect the brain by scavenging free radicals that are formed when the brain sustains an injury. It is also an anti-inflammatory compound that may block the synthesis of pro-inflammatory cytokines in the injured brain, significantly slowing the breakdown of the blood-brain barrier and in the development of apoptosis and necrosis. Dexanabinol is also a weak and safe NMDA antagonist that prevents the lethal massive influx of calcium ions into the cells of the injured brain. Dexanabinol is the only compound demonstrating these multiple mechanisms of action that has been tested in the treatment of TBI.
Pharmos has broad neurological and neuro-vascular inflammation-based R&D programs based on its platform of novel synthetic non-psychotic cannabinoid compounds. The compounds are in various stages of pre-clinical testing for stroke, Multiple Sclerosis, pain and other neuro-inflammatory related indications.
Pharmos Corporation discovers and develops novel therapeutics to treat a range of inflammatory and neurological disorders, such as traumatic brain injury and stroke. The Company has an extensive portfolio of drug candidates under development, as well as discovery, pre-clinical and clinical capabilities.
Statements made in this press release related to operational expectations and projections of the Company and to the continued market penetration of its drug products 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
Web Site: http://www.pharmoscorp.com