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SOURCE: Pharmos Corporation
SEATTLE, Oct. 7 /PRNewswire/ -- Pharmos Corporation (Nasdaq: PARS - news) will present the results of a successful Phase II clinical study with dexanabinol, a non-psychotropic synthetic analog of marijuana, in the treatment of severe head trauma patients. Highlights of the study included a significant reduction in intracranial pressure, a 26% reduction in mortality, and a higher percentage of patients able to resume a normal life (``Good Neurological Outcome'') among the treated group. No drug is currently approved to treat severe head trauma, the leading cause of death among children and young adults in the U.S.
``These study results are promising and open the door to a Phase III study in the U.S. and Europe next year,'' said Dr. Haim Aviv, Pharmos Chairman and CEO.
``The demand for a product like dexanabinol is difficult to overstate, since there is no drug currently available for the treatment of head trauma. In the U.S. alone, about 370,000 cases of severe head trauma are hospitalized every year, with the global incidence more than twice that amount,'' said Dr. Nachshon Knoller, the study's principal investigator and a neurosurgeon at the Sheba Medical Center in Israel.
Dexanabinol Shown to be Safe and Well-Tolerated
Clinical endpoints established an excellent safety profile of the drug in the treated patients. There were no unexpected adverse experiences reported for either the drug treated or placebo group. Intracranial pressure above a threshold of 25 mmHg, an important risk factor and a predictor of poor neurological outcome, was significantly reduced in the drug-treated patients through the third day of treatment, without concomitant reduction in systolic blood pressure. The incidence of low blood pressure, which may worsen the patient's condition, was also significantly better in the treated group at 13%, compared to 38% in the placebo group. The mortality rate of 10% (3/30) in the dexanabinol group compared favorably with a 13.5% rate in the placebo group (5/37). The investigators concluded that dexanabinol was shown to be safe and well-tolerated in severe head trauma patients.
Neurological Outcome Measures Established a Trend of Efficacy
Neurological outcomes in the study, assessed periodically up to 6 months after injury, established a trend of efficacy. The percentage of patients achieving Good Neurological Outcome, the highest score on the five level Glasgow Outcome Scale used to assess the recovery of head trauma patients, was higher in the drug-treated group at each measurement. Among the most severely injured patients in the study, a better outcome was consistently observed among the treated group than among the non-treated group. However, no difference was observed at six months after treatment between the treated and non-treated groups in the top two levels of the Glasgow Outcome Scale, combining patients who resumed normal life with those requiring some assistance in daily life.
Study Subjects Characteristic of Severe Head Trauma Patient
The multi-center, double-blind, placebo controlled, randomized study was carried out in all six trauma centers in Israel. Patients received an intravenous injection of either dexanabinol or placebo within 6 hours of the injury. Demographically, all 67 patients were fairly representative of the characteristics describing the severe head trauma patient, which are often young men injured in motor vehicle accidents.
The drug (30 patients) and placebo (37 patients) groups were found essentially to be balanced for all known important baseline parameters including age, severity of coma, and brain computerized tomograph (CT) classification.
``I am very excited that dexanabinol was beneficial to this initial group of patients and I look forward to confirming these findings in a Phase III trial,'' said Dr. Anat Biegon, Pharmos Vice President of Research & Development.
Dexanabinol is one compound in a family of synthetic analogs of marijuana invented by Prof. Raphael Mechoulam of the Hebrew University of Jerusalem and licensed to Pharmos for commercial development. The market for dexanabinol in the treatment of severe head trauma may reach $500 million annually and could exceed $1 billion if other neurological conditions such as stroke are treated with the drug.
Dr. Knoller will present the Phase II trial results later today at the Congress of Neurological Surgeons' Conference in Seattle.
Pharmos Corporation is a pharmaceutical company engaged in the redesign, development and commercialization of proprietary products that enhance the efficacy of existing compounds and reduce their side effects. The Company focuses primarily on drugs for post-surgery and allergy related eye-care, neuroprotective agents for the treatment of central nervous system disorders, newly designed molecules for the treatment of cancer and unique drug delivery products. In March 1998, the Company, together with its marketing partner Bausch & Lomb Pharmaceuticals Inc., received approval from the Food and Drug Administration to manufacture and market two ophthalmic products, Lotemax(R) and Alrex(R). Both products were launched in June 1998.
This news release contains forward-looking statements that involve risk and uncertainties. The development of the company's products may differ materially from the company's expectations. Among the factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development, action of regulatory authorities and the results of further trials.
SOURCE: Pharmos Corporation
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