Up .50 this am in pre-market trading!
Pharmos Completes Enrollment of Brain Injury Patients in Phase III Study of Dexanabinol
Monday March 15, 4:02 pm ET
Study Results Expected Around Yearend
ISELIN, N.J., March 15 /PRNewswire-FirstCall/ -- Pharmos Corporation (Nasdaq: PARS - News) announced today that it has completed patient enrollment in its pivotal Phase III study of dexanabinol for the treatment of severe traumatic brain injury (TBI). The planned recruitment of 860 patients was completed with enrollment of a patient at the University of Virginia neurosurgery unit. A total of 86 trauma centers throughout the U.S., Europe, Israel and Australia participated in the study. The Company expects to unblind the study data and announce initial results near the end of this year.
"Our efforts are now centered on collecting all the relevant data as required by the trial protocol," said Gad Riesenfeld, Ph.D., President and COO.
"I am very satisfied with the quality of the study," said Andrew I.R. Maas, M.D., Director of Neurosurgical Intensive Care, Erasmus University Medical Center, Rotterdam, the Netherlands, Chairman of the European Brain Injury Consortium, and the head of the dexanabinol trial Steering Committee. "We believe that taken together, the study design as reflected in the clinical protocol, the statistical plan, and the dedicated work of the study investigators and the steering committee, are providing the best opportunity for the Company to demonstrate the neuroprotective activity of dexanabinol in TBI patients."
The purpose of the double-blinded, placebo controlled study is to evaluate the efficacy and safety of dexanabinol as a neuroprotectant agent in severe TBI patients. Enrolled patients were given a single dose of 150mg dexanabinol or (placebo) vehicle within six hours after injury and received the standard care normally provided to TBI patients in intensive care units. The primary endpoint for the study will be patient outcome as measured on the Glasgow Outcome Scale - Extended (GOSE) six months after injury.
Pharmos discovers, develops, and commercializes novel therapeutics to treat a range of indications, in particular neurological and inflammation- based disorders. The Company's first neuroprotective product is dexanabinol, a tricyclic dextrocannabinoid, currently undergoing clinical testing as a treatment for TBI and as a preventive agent against post-surgical cognitive impairment. Other dextrocannabinoid compounds and CB2 receptor agonist compounds from Pharmos' proprietary synthetic cannabinoid library are being studied in pre-clinical programs targeting a variety of other disorders.
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
Email this story - Set a News Alert