Pharmos Appoints Quintiles to Manage European Phase III Clinical Trial; Agreement Signed with the European Brain Injury Consortium
ISELIN, N.J., June 13 /PRNewswire/ -- Pharmos Corporation (Nasdaq: PARS; Easdaq: PHRM) announced today the appointment of Quintiles (UK) Limited, a subsidiary of Quintiles Transnational Corporation, a global contract research organization, to monitor and manage the data for the Company's European Phase III trial of dexanabinol in patients with severe traumatic brain injury (TBI). Quintiles will coordinate and implement most of the study-related activities. This multi-center, multinational pivotal trial, scheduled to commence during the third quarter of this year, will enroll several hundred patients in approximately thirty centers situated in seven European countries and Israel.
``After an extensive review process, we felt that Quintiles would best meet our needs and will allow us to move forward more rapidly with our TBI program,'' said Dr. Michael Schickler, Pharmos Vice President of Development.
Pharmos has also signed a collaboration agreement with the European Brain Injury Consortium (EBIC), an organization of leading European neurosurgeons, neurologists, intensive care experts and anesthesiologists in approximately 150 centers across Europe. EBIC will advise Pharmos on potential participating centers and practical issues concerning all aspects of design, conduct and analysis of the clinical trial. EBIC will also act as a central point for the collation of information from all centers to assure a high quality of the study. In addition, EBIC members will participate in the study's steering committee that will oversee the activities relating to the design and conduct of the trial.
Earlier this year, Pharmos successfully completed a double-blind, placebo-controlled, randomized rising-dose Phase II trial with 101 patients. The results of that study highlighted dexanabinol's safety and its ability to prevent elevation of intracranial pressure, and enabled the selection of the dose and establishment of other study design parameters for the Phase III trial.
Currently there is no drug approved to treat TBI, the leading cause of death and disability among young adults in the U.S. and worldwide. Estimates of the potential worldwide market for an approved product to treat TBI approach $1 billion annually.
Pharmos Corporation is a bio-pharmaceutical company that develops and commercializes products for the ophthalmic, central nervous system, neurological and other key healthcare markets. The Company has a diverse product pipeline that includes: marketed products with superior therapeutic indices, and drug candidates with enhanced molecular structures that display improved safety and/or efficacy properties compared to the parent molecules or to competing products.
Statements made in this press release related to the future beneficial expectations of the Company are considered ``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 |
