Feuerstein's Biotech-Stock Mailbag

Dr. Paul Aisen, an Alzheimer's disease expert at the University of California San Diego, penned the Lancet editorial on Flurizan:

"The Phase II trial of tarenflurbil [Flurizan] was designed to show slowing of cognitive and functional decline in mild to moderate AD, with enrollment of about 200 patients in a 1-year trial. The primary analysis failed: There was no overall effect on the primary outcomes. But planned analyses nonetheless suggested that the drug had an influence on the outcome measures: there was significant interactive effect of treatment and baseline cognitive function on the change in outcomes."

Aisen goes on to say:

"Do these results prove the efficacy of tarenflurbil in slowing decline in mild AD? No -- the data are consistent with a beneficial effect in mild AD, but are hardly conclusive."

I'll be blunt: Aisen's reputation is that of someone who can be a bit Pollyannaish on experimental Alzheimer's drugs. He's a regular on the Wall Street health care consulting circuit, and I've never heard him say a discouraging word about any drug, no matter how iffy the data look. Case in point, he was a big supporter of Neurochem's NRMX efforts with Alzhemed.

So, his rather lukewarm take in this Lancet article comes as somewhat of a surprise, and not in a good way.

I don't have room here to go into much detail about the phase II Flurizan study, other than to say that the benefit was seen only in mild-Alzheimer's patients, and then only after a retrospective subgroup analysis was conducted. (Actually, they found the most positive data from a subgroup of a subgroup of mild patients.) Most interestingly, moderate Alzheimer patients on Flurizan did much worse on all outcomes than placebo patients. That's not a good sign, even if the Flurizan phase III study enrolls only mild patients.