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Pharmos Announces Clinical Results from Phase 2a Trial of Topical Diclofenac NanoEmulsion Cream
Date:11/19/2008

Study did not achieve statistical significance

ISELIN, N.J., Nov. 19/PRNewswire-FirstCall/ -- Pharmos Corporation (Nasdaq: PARS) today announced results from its Phase 2a clinical trial of its topical NanoEmulsion (NE) drug delivery technology formulated with 3% Diclofenac Diethanolamine.

The multi-center, randomized, double-blinded, placebo-controlled study evaluated the safety and efficacy of the Company's 3% Diclofenac Diethanolamine NanoEmulsion cream in 104 patients with chronic pain due to osteoarthritis of the knee. Patients applied the topical cream three times daily for 28 days.

The study did not achieve statistical significance in its primary efficacy endpoint, nor in several secondary endpoints. The effect witnessed did not measure up to other topical NSAID (non-steroidal anti-inflammatory drug) products already approved or currently in development in the US.

This study confirmed the safety of the 3% NanoEmulsion Diclofenac Diethanolamine cream previously demonstrated in the Phase I study. The majority of the reported adverse events (AE's) were defined as mild in severity and most of them were regarded by the investigators as not drug related. No Serious AE's were reported and the effect of the NanoEmulsion cream on the skin was minimal.

Pharmos has decided to discontinue its topical NanoEmulsion drug delivery program. The Company's operations in Israel were closed effective October 31, 2008, and the Company is seeking to license / partner its only remaining program -- the CB2 Selective Agonist program targeting pain and inflammation. No further development work is being conducted on that program.

The Company is focusing all its resources on its Dextofisopam clinical trial for Irritable Bowel Syndrome
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SOURCE Pharmos Corporation
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