Pharmos Corporation announced the submission to the FDA of an Investigational New Drug (IND) application to begin U.S. patient enrollment in its pivotal Phase III trial of dexanabinol for the treatment of traumatic brain injury (TBI). Subject to successful completion of FDA review, the Company estimates a total of up to 30 U.S. trauma centers will join the 60 centers in Europe, Israel and Australia already participating in the study. More than 400 patients have been enrolled in the trial to date.

"There is a tremendous unmet need in the treatment of TBI, as only supportive care is currently available to patients," said Dr. Gad Riesenfeld, President and C.O.O. "Expanding into the U.S. will accelerate patient enrollment in the pivotal study, and thereby move us more quickly toward our goal of completing dexanabinol's clinical development." Dr. Nadim Kassem, Vice President of Clinical and Regulatory Affairs, added, "We designed our large-scale study of severe TBI patients to address the challenges inherent in developing a therapeutic product to treat this very serious indication."

TBI is a leading cause of death and disability among a predominantly young population, mostly victims of accidents. According to the U.S. Centers for Disease Control, about 1.5 million Americans annually sustain an injury to the brain. The incidence of TBI is about eight times the number of people diagnosed with breast cancer and 34 times the number of new cases of HIV/AIDS each year. An estimated 5.3 million Americans (2% of the population) currently live with disabilities resulting from TBI, and about one in four adults with TBI are unable to return to work one year after their injury. Hospitalization of TBI costs the nation upwards of $56 billion each year, including decreased tax revenues and increased welfare costs that result when those injured, or their caregivers, are unable to return to work. No effective drug therapy to treat the effects of TBI is approved in the U.S. or internationally, leaving TBI a totally unserved market worldwide.

Pharmos is lending its support toward improving the understanding of TBI and its treatment through a sponsorship at the first joint symposium of the National and International Neurotrauma Societies (N-INTS), taking place October 27 - November 1, 2002 in Tampa, Florida. Pharmos' presence as sponsor will be most visible during the October 28 session, "TBI: History and Challenges for the Future," presented by Professor Graham Teasdale, Chairman of the European Brain Injury Consortium.