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Biotech Data Mining Comes Up Empty

BOSTON ( TheStreet) -- I've long warned investors to be wary of companies that use dubious scientific analysis to spin positive results from what are really failed clinical trials.

Call it post-hoc data mining or retrospective data dredging, but by either name, the purpose of these all-too-common tactics is usually to deflect investors' attention away from bad news.

Apricus Biosciences (APRI - Get Report) and Cel-Sci (CVM - Get Report) issued separate press releases in the past week which relied heavily on post-hoc data mining to hype the prospects of experimental -- and deeply flawed -- drugs in their respective pipelines. Knowing how to spot the red flags in these types of announcements can save you a lot of pain and losses down the road.

The headline on Apricus' announcement set off alarm bells immediately: "Apricus Biosciences Reports Reanalysis of Its U.S. Phase III Trials for MycoVa Showing Drug is Effective in Mycological Cure Resulting in Eradication of Nail Fungus." [Emphasis mine.]

Re-analysis? What happened to the first analysis of the phase III trials of MycoVa?

Apricus doesn't say, but Google and SEC filings are a big help. In August 2008, Apricus (then known as NexMed) announced that its partner Novartis decided against seeking U.S. approval for MycoVa (then known as NM100060) based on disappointing results from two double blind, placebo-controlled phase III clinical trials.

One year later, in July 2009, Apricus/NexMed announced that Novartis was terminating its partnership for NM100060/MycoVa based on results from a third phase III study which compared MycoVa to Loceryl, a topical nail laquer marketed in Europe. This European phase III study failed although Apricus was spinning the results even back then, claiming that a "post hoc" analysis showed MycoVa worked better than Loceryl in patients with mild toenail fungus. Unfortunately for Apricus, the study enrolled patients with mild and moderate toenail fungus.

Three failed phase III studies, one dropped Big Pharma partnership and two years later, Apricus is trying to convince investors that there's life left in MycoVa. This time, Apricus claims that a re-analysis of the two U.S. clinical trials found MycoVa cures toenail fungus better than placebo in patients who do not also have athlete's foot.
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