Wednesday October 7, 5:00 am Eastern Time
Company Press Release
SOURCE: Pharmos Corporation
Pharmos Announces Successful Phase II Head Trauma Study; Marijuana Analog Benefits
Brain Injured Patients
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. |
