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Pharmos Corporation Announces Modification to Dextofisopam Trial Size, Objectives Can Still Be Achieved
Date:3/4/2009

ISELIN, N.J., March 4 /PRNewswire-FirstCall/ -- Pharmos Corporation (Nasdaq: PARS) announced today that it has completed a reevaluation of the size of the Phase 2b Dextofisopam trial for Irritable Bowel Syndrome IBS -D + A and has concluded that a smaller trial could achieve the objectives of the trial. As the Phase 2b trial is not going to be a registration /pivotal trial, the objectives that must be achieved in order to progress into a Phase 3 trial are to: (1) determine the best dose to move into Phase 3, (2) replicate the efficacy observed in the Phase 2a trial and, (3) determine the optimal endpoints for Phase 3. In addition, the Company's plan is to ensure that the Phase 2b package is attractive to a pharmaceutical company for further development.

The Company has determined that a 300 patient trial should be of sufficient size to achieve its objectives. Consequently, the current Dextofisopam trial targeting 480 patients will be reduced to 300 patients. This trial will continue to have four cohorts of female patients. Each cohort will have approximately 75 patients. There are three drug cohorts at 100 mg BID, 200mg BID, 300mg BID and placebo.

The trial currently has 295 patients randomized and enrollment will be closed when the 300 patient level is reached. The Company's decision to reduce the size of the current Phase 2b trial has been based on clinical and statistical input from the Company's expert consultants. An analysis of the trial sizes of other IBS drug candidates in Phase 2b trials indicated that, with approximately 75 patients per cohort, the Company would have sufficient numbers on which to make a decision on whether or not the drug can progress into Phase 3 testing.

As previously disclosed, the Company is seeking to raise the additional capital necessary to complete the Phase 2b trial. Assum
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SOURCE Pharmos Corporation
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