PRAN (1.75 +29%) New Analysis of Prana's Clinical Trial Is Published in the Journal of Alzheimer's Disease
2010-04-19 11:00 ET - News Release
NEW YORK, NY -- (MARKET WIRE) -- 04/19/10
Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today announced that the authoritative scientific journal, Journal of Alzheimer's Disease, published an article on April 19 about Prana's lead drug candidate for Alzheimer's disease, PBT2, providing new analysis that it is effective in reversing dementia symptoms. The analysis, conducted by Professor Ashley Bush of The Mental Health Research Institute and The University of Melbourne, Australia, is based on tracking and ranking the responses of each individual patient, rather than only groups of patients, in Prana's PBT2's Phase IIa Alzheimer's disease clinical trial.
The results of the Phase IIa clinical trial, previously reported in The Lancet Neurology (July 2008 and an erratum in July 2009), showed that patients with mild Alzheimer's Disease treated with 250mg of PBT2, experienced an overall statistically significant improvement in Executive Function on a Neuropsychological Test Battery (NTB) within 12 weeks of treatment.
"Improvements in Executive Function is strongly related to improvement in daily function and to the quality of the daily life of patients," noted Dr. Jeffrey Cummings, Director, Alzheimer Disease Research Center, UCLA, and Chairman of Prana's Scientific Advisory Board.
"Very few drugs in clinical development have been able to bring these benefits to Alzheimer's Disease patients. I am very encouraged by these findings," concluded Dr. Cummings.
The Journal of Alzheimer's Disease paper reports the results of a post-unblinding analysis of the cognitive data that was not included in the original paper. The objective of the analysis was to see how individual patients who were receiving PBT2 responded compared to the individual patients who only received placebo. Importantly, even placebo patients showed some improvement in the tests because of a 'learning effect' of repeated testing. This new analysis has adjusted for this and demonstrated that:
81% of patients on the 250mg dose of PBT2 responded better on the Executive Factor NTB score than the best performing patient on placebo.
41% of patients on the 250mg dose of PBT2 responded better on the overall Composite NTB score than the best performing patient on placebo (of which Executive Function is one of 2 parts).
Asking the specific question, 'What is the probability that any patient who showed cognitive improvement was receiving PBT2?,' the paper reports there was a significant probability that:
Patients who improved in Executive Function were probably receiving 250mg of PBT2 (p=1.3 x 10-(9))
Patients who improved their Composite NTB were probably receiving 250mg of PBT2 (p=.0007)
Improvement in ADAS-Cog, a measure of memory and cognition, almost achieved a statistically significant level in the 12 week trial. Patients who improved their ADAS-Cog score were probably receiving 250mg of PBT2 (p=.056).
Professor Colin Masters of the Mental Health Research Institute and internationally acknowledged leader in Alzheimer's Disease research, commented that: "These results are very exciting given that they were achieved in mild Alzheimer's Disease sufferers in a relatively short period of time. Based on clinical trial outcomes to date, Prana's therapeutic strategy stands up as one of the safest and most effective means of treating the disease."
PBT2 targets the pathological interaction between A-beta and synaptic metal ions to prevent downstream toxic A-beta oligomer formation. PBT2 can also transfer metal ions otherwise trapped by A-beta oligomers into neurons, helping to promote normal memory function.
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