Catalyst stock dives on news of drug trials

Catalyst Pharmaceutical Partners, a Coral Gables company trying to develop a single drug, announced Friday that its phase II clinical trial to treat cocaine addiction had failed to meet its intended goal.

The news sent the stock plummeting, to a close Friday at 90 cents -- down 57 percent for the day.

The company said in a press release that the trial of the drug, called CPP-109, did not show that ''a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period,'' which was weeks 11 and 12 of the trial.

Chief Executive Patrick J. McEnany told The Miami Herald, ``We've only begun our analysis of the data. The data is immense. We're trying to get our arms around it.''

He noted the drug had performed well in three prior human studies, and he wasn't sure why this study was different. ``Cocaine addicts are a very unpredictable group.''

A study in Mexico had much more positive results, he said, and Catalyst scientists will be examining whether differences in demographics could have led to different results.

Over the next several months, he said Catalyst plans to analyze the data and decide whether it should attempt a new study for cocaine addicts. It is also pursuing the drug as a way of treating addiction for methamphetamine.

INITIAL OFFERING

The company started trading publicly in November 2006, raising $21 million in its initial public offering. A Miami Herald report on Catalyst in January 2007 noted that the company ``has a single drug, but it has huge potential.''

The drug, commonly known as vigabatrin, was developed in the 1970s for treatment of epilepsy. Under the name Sabril, it is sold by a Belgium firm in more than 60 countries, but not the United States because of concerns of a side effect damaging eyesight.

Since the 1980s, vigabatrin has been studied by U.S. government researchers for possible use with addicts because it suppresses the brain's response to dramatic increases in dopamine.

''Drug development is a risky business,'' McEnany told The Herald in 2007. ''There is no doubt about it,'' says McEnany.

WARNED OF DELISTING

Last week, the company announced it had been informed by NASDAQ that it no longer was in compliance with the requirement to have a minimum of $10 million in stockholders' equity. As of March 31, shareholder equity was about $7.7 million. The company has until June 3 to come up with a plan to become compliant.

McEnany said Friday the company has enough cash to complete its analysis of the cocaine trial, work on the methamphetamine study and continue operations through 2010 without additional funding.

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