Pharmos Corp. (Nasdaq: PARS) has concluded that a smaller trial could achieve the objectives of the Phase IIb clinical trial of Dextofisopam for Irritable Bowel Syndrome. The company apparently lacks the wherewithal to complete the originally planned trial. Dextofisopam is the company's sole remaining intellectual property, and Pharmos has already fired most of its staff.
Pharmos said that a 300 patient trial should be of sufficient size to achieve its objectives, instead of the 480 patients originally planned. The trial currently has 295 patients randomized and enrollment will be closed when the 300 patient level is reached.
Pharmos is taking a risk by reducing the trial size. A smaller size risks the possibility of not achieving significant results, but the company says that, after consulting with the trial statistical committee, there was still a good chance of obtaining statistically significant results. The company hopes that even less statistically strong results will be sufficient to sell Dextofisopam to another company that will pursue a Phase III clinical trial.
Even with the cutback, Pharmos said that it seeking to raise additional capital which is necessary to complete the Phase IIb trial. It added that, assuming it raises the capital, top line clinical data should be available before the end of 2009.
Pharmos stated in its financial report for 2008 that it had $4.7 million in cash at the end of last year, which would be enough through March 2009. This suggests that it needs to raise several million dollars to complete the Dextofisopam trial, even at the reduced cost of the smaller trial size.
Pharmos closed at $0.08 yesterday, giving a market cap of $2.1 million.
Published by Globes [online], Israel business news - www.globes-online.com - on March 5, 2009
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