ANN ARBOR, Mich. ( TheStreet) -- Adeona Pharmaceuticals' ( AEN) oral zinc nutritional supplement reaZin failed to halt memory loss or improve cognitive function in Alzheimer's patients, according to data from a small study presented Thursday evening. Regardless of the poor results from the reaZin Alzheimer's study, traders were buying shares of Adeona Friday morning. The stock rose 6% to $1.83 in early trading boosted by Adeona's press release claiming the study was successful because it met the primary endpoint. Unfortunately, the study's primary endpoint is obvious and clinically meaningless to Alzheimer's patients. Treatment with six months of reaZin increased levels of zinc and reducing levels of copper in patients' blood compared to a placebo, according to the study results. Of course, that's exactly what one would expect any simple and relatively inexpensive zinc tablet to do. Adeona is trying to pass off reaZin as a "medical food" -- not a drug but more like a nutritional supplement -- that somehow aids or assists in the treatment of Alzheimer's. The data presented Thursday at the American Academy of Neurology annual meeting demonstrated no such thing. Treatment with reaZin for six months resulted in a miniscule 0.41-point improvement over placebo on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog), the most widely used and recognized measure of cognitive function and memory used in Alzheimer clinical trials. This result was nowhere near statistically significant, said Adeona. Adeona claims this 0.41-point improvement represents a trend in favor of reaZin, but the company is vastly overstating its case. In Alzheimer's clinical studies, an improvement in the ADAS-cog score of around 3-4 points over six months is generally considered positive and clinically meaningful to patients. ReaZin came nowhere close to producing that kind of result with just a 0.41-point improvement over placebo. Two other measures of memory and cognition used in the reaZin study -- the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) and the Mini Mental State Examination (MMSE) -- likewise failed to demonstrate any significant benefit favoring Adeona's zinc tablet over placebo. Adeona's posted a copy of the reaZin study poster on its web site. Biotech investors should take a look at the poster to see how many red flags they can spot. Among the study's problems:
Adeona enrolled 57 patients with Alzheimer's and mild cognitive impairment, yet data are presented on only 42 patients. Fifteen patients, or 26% of the total, are missing. The reaZin poster say the 15 patients dropped out of the study -- 7 from the placebo arm and 8 from the reaZin arm -- but says nothing about why the patients dropped out or why the data collected from these patients before they dropped out, if any, is not included in the analysis. Steve Kanzer, an Adeona co-founder, a current director and the company's former chief executive officer, is listed as an author and researcher of the reaZin study, according to the poster. Kanzer is a lawyer by training, so what was his role in conducting a scientific study of reaZin? The reaZin poster provides no information about the baseline characteristics of the patients enrolled in the study. What was their cognitive ability at the start of the study? Were the two arms of the study balanced in terms of the types of patients and their mental status? The poster tells us nothing, so there is no way to determine whether potential imbalances skewed any of the data analyses.
ReaZin, also known as zinthionein, is a once-daily tablet containing food-safe zinc designed to cause less stomach upset than other zinc nutritional supplements. Adeona says it is developing reaZin for the "dietary management" of Alzheimer's disease. Some medical research suggests that Alzheimer's patients have lower blood levels of zinc than people without the disease, although there is no substantive data yet in Alzheimer's patients to suggest that raising the level of zinc to normal levels can have a beneficial impact on the disease. If anything, Adeona's reaZin clinical study presented Thursday adds scientific heft to the theory that boosting zinc levels is no help to Alzheimer's patients at all. --Written by Adam Feuerstein in Boston. >To contact the writer of this article, click here: Adam Feuerstein. >To follow the writer on Twitter, go to http://twitter.com/adamfeuerstein. >To submit a news tip, send an email to: firstname.lastname@example.org.