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TheStreet Open House

Biotech Data Mining Comes Up Empty

That's a classic data dredge. The MycoVa studies in "all comer" patients with mild to moderate toeail fungus failed as designed originally, so Apricus just ignores the data and finds a subgroup of patients (those who have toenail fungus but not athlete's foot) where MycoVa allegedly works. Victory declared.

Except, of course, that the studies do not prove at all that MycoVa works in toenail fungus, non-athlete's foot patients because the studies weren't designed with this goal in mind. What looks good in a press release will almost certainly be dismissed as pseudo-scientific nonsense by regulators, if Apricus ever follows through on a promise to seek approval for MycoVa based on this dubious "re-analysis."

Moving on to Cel-Sci, which announced last week that a "meta analysis" of four phase II clinical trials involving 120 patients with head and neck cancer found a "highly statistically significant" reduction in total cholesterol following treatment with the company's experimental drug Multikine.

I must admit to confusion reading the Cel-Sci announcement a few times because Multikine is being developed as a treatment for head and neck cancer. In fits and starts, Cel-Sci is now trying to conduct a phase III study. Who cares if Multikine lowers cholesterol, especially since Cel-Sci has never before discussed the possibility of developing Multikine as a cholesterol-lowering drug? (I'm also putting aside the nontrivial issue of explaining how Multikine might lower cholesterol, since Cel-Sci doesn't offer any.)

Cel-Sci's claim about Multikine lowering cholesterol is just more hyer-promotional data mining and doesn't pass the smell test. According to regulatory filings, Multikine was studied in previous clinical studies enrolling over 200 patients, so how does Cel-Sci explain a meta-analysis that includes four studies and 120 patients? How were those studies and patients selected and why were others left out?

A 2005 phase II study of Multikine in head and neck cancer published in the Journal of Clinical Oncology was almost certainly included in the meta-analysis, but that study makes no mention of any cholesterol-lowering effects of the drug. In fact, the study publication doesn't mention cholesterol at all.

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