Adam Feuerstein
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Fresh from a weeklong vacation, the Biotech Mailbag is open once again. Hadi, an overseas reader, emails to ask about the prospects for Epix Pharmaceuticals (EPIX Quote - Cramer on EPIX - Stock Picks) and its Alzheimer's drug PRX-03140. The currently available clinical data on PRX-03140 (referred to as PRX for shorthand) is pretty skimpy, so I think it's too early to make any sort of judgment on the drug's prospects. What we have so far is a small, 80-patient phase IIa study that looked at multiple doses of PRX alone and in combination with Aricept. Treatment duration was short, just two weeks. In the monotherapy portion of the study, nine patients on the 150 mg dose of PRX reported a 3.6-point improvement in their ADAS-cog score (a test of cognitive function) compared to a 0.9 point drop in the ADAS-cog score for placebo patients. The result was statistically significant. This positive outcome, however, is confounded by a mistake in the data analysis that forced Epix to restate the results. (The previous data were better, but wrong.) Moreover, with such small numbers of patients, small differences in patient outcomes can dramatically change the results. Lastly, the data from the combination portion of this study (PRX plus Aricept) were inconclusive, which is a bit of a puzzler. PRX is supposed to work by boosting brain levels of acetylcholine, an important transmitter of nerve impulses. Theoretically, then, it should work synergistically with Aricept, which is an acetylcholinesterase inhibitor that works by preventing or slowing the breakdown of acetylcholine. Perhaps the study was too small and the two-week treatment too short to show an effect for the PRX-Aricept combination. Still, if the PRX monotherapy data were positive, why not see something positive from the combination therapy as well?
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