To: tom r. phillips who wrote (1360 ) 12/20/2004 9:56:10 AM From: rjk01 Respond to of 1386 from Globes; Pharmos Phase III: Dexanabinol not effective against TBI CEO Dr. Haim Aviv: It's unlikely we'll continue with dexanabinol for traumatic brain injury. Pharmos shares plunged in pre-market trading. Globes correspondent 20 Dec 04 14:13 Pharmos (Nasdaq:PARS) announced today top line results of its pivotal Phase III trial of dexanabinol to treat severe traumatic brain injury (TBI). As reported earlier today by "Globes", dexanabinol did not demonstrate efficacy as measured by the Extended Glasgow Outcome Scale (GOSE). In pre-market trading, Pharmos shares have so far dropped to $0.85, meaning that they have lost nearly 76% of their value. The double-blind, randomized, placebo-controlled trial was conducted in 86 trauma centers in 15 countries. In the 861 patient trial, 846 patients were available for analysis, 428 treated with dexanabinol and 418 treated with placebo. The randomization provided well- balanced groups for this study. The company noted that the trial demonstrated an excellent safety profile with no evidence of excess side effects in the dexanabinol- treated patients. The company also noted that not all secondary endpoints have been analyzed; however, no differences were observed in mortality or in analysis of subgroups in the trial. Pharmos chairman and CEO Dr. Haim Aviv said, "We are very disappointed and frankly somewhat perplexed that we did not observe any neuroprotective effect of dexanabinol in TBI. This trial was one of the largest ever completed in TBI. TBI is a severe injury of the most complex organ in the body and involves a patient population with high heterogeneity. It is therefore a very difficult indication to study, but we believe this study was performed according to the highest scientific standards and included important innovative aspects in the design and analysis aimed at improving the quality of the study. "In the next few weeks, we will carefully analyze the results of this trial before making final decisions about our future plans, but it is unlikely that we will continue to develop dexanabinol for TBI. We plan, however, to continue developing dexanabinol for cognitive impairment in cardiac surgery, and we also remain committed to developing a drug candidate for pain." Dr. Andrew Maas, chairman of the European Brain Injury Consortium and chairman of the study's Steering Committee, said that the committee will work closely with the company to analyze the data from the trial "in order to garner scientific and medical information that will be valuable in treating TBI patients." Pharmos president and COO Dr. Gad Riesenfeld said, "We all share the disappointment in the results for TBI. However, we will continue to analyze the results of the Phase II coronary artery bypass graft (CABG) trial of dexanabinol and are committed to continuing that program. "In addition, we expect to initiate clinical studies of our lead CB2- selective drug candidate, PRS-211,375, during the first half of 2005 for a pain indication. This compound and others in the preclinical pipeline have demonstrated very positive results in a range of pain and autoimmune disease animal models. We believe that the pipeline represents significant potential value for the company." Published by Globes [online], Israel business news - www.globes.co.il - on Monday, December 20, 2004