BROOMFIELD, Colo., July 14 /PRNewswire/ -- Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system diseases, today announced further evidence for genetic interactions impacting the efficacy of the ketogenic compound AC-1202 (Axona(TM)) in Alzheimer's disease. New data from the company's previously completed double-blind, placebo-controlled trial in patients with mild-to-moderate Alzheimer's disease demonstrates an interaction between two genetic markers that strongly influence the therapeutic response in patients. Dr. Samuel Henderson, Executive Director of Research, will present these results at the 2009 International Conference on Alzheimer's Disease (ICAD) sponsored by the Alzheimer's Association.
Previous analysis of the study revealed that patients administered AC-1202 who lacked the epsilon 4 variant of the APOE gene (E4(-)), demonstrated significant improvement from baseline values in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) and improvement compared to placebo of 4.77 at Day 45 and 3.36 at Day 90 (p <0.05). ADAS-Cog, a neuropsychometric battery of tests that measures short-term memory and cognition, is probably the most widely used cognitive instrument used in clinical trials of anti-dementia drugs within the United States and Europe. Numerous clinical studies have demonstrated that modest improvements in ADAS-cog scores - on the order of 2 to 3 points over the course of a year - have been associated with significant cost reductions in overall managed care expenditures.
In the population of patients who were both APOE4(-) and lacked the C/C polymorphism in IDE 7, more pronounced improvements in ADAS-cog scores than those previously reported were observed at each assessment time point (Day 45, 90 and 104). At Day 45 the improvement in ADAS-cog score was 4.18 (p=0.0004), while at Day 90 the difference was 4.73 (p=0.001). Of interest, a significant difference in cognitive test scores of 3.27 was observed two weeks after termination of AC-1202 treatment (p=0.034). This finding suggests that daily administration of AC-1202 may produce lasting effects in those patients with this combination of genotypic markers.
"This pharmacogenomic finding provides both insight into the mechanism of ketone-based therapies for Alzheimer's disease, and also allows for the identification of patients who may respond best to therapy, " said Dr. Samuel Henderson, Research Director at Accera. "This is the first scientific report of the role of IDE and its interaction with APOE on therapeutic efficacy in Alzheimer's disease patients."
About Alzheimer's Disease
Alzheimer's disease, the most common form of dementia, is a progressive and fatal disease for which there is no cure. In the United States, 5.2 million people are living with AD, and it has become the sixth leading cause of death. The disease attacks the brain's cells, resulting in loss of memory, executive function and language skills.
About Accera, Inc.
Accera, Inc. is a privately held commercial-stage biotechnology company that developed and now markets Axona in the US. Axona is a prescription-only medical food intended for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's disease. In clinical trials, Axona has been shown to safely improve cognitive function and memory in AD patients. Axona addresses the hypometabolism or defective metabolism of glucose that occurs in those areas of the brain that are involved in Alzheimer's disease. Accera engages in research, development and commercialization of other clinical applications for Axona.
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