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Genetic Profile Identified for Alzheimer's Patients Showing Heightened Response to Accera's Breakthrough Product Axona®
Date:10/17/2011

BROOMFIELD, Colo., Oct. 17, 2011 /PRNewswire/ -- Accera, Inc., a biotech company specializing in cognitive health, announced today that it has identified the genetic profile of Alzheimer’s disease (AD) patients who have a high probability of responding to Axona® (AC-1202), a prescription medical food product available at pharmacies nationwide.

In this current study, variances in the DNA sequences associated with the genes responsible for producing insulin degrading enzyme (IDE) and the pro-inflammatory cytokine interleukin-1beta (IL1B) were shown to be highly predictive for improvement in cognition among patients receiving Axona.  

Other studies have shown a correlation between an increased risk for AD among carriers of the apolipoprotein E4 allele (APOE4), and Accera has previously published its findings from a double-blind, placebo-controlled study showing that AD patients who were non-carriers of the APOE4 gene (APOE4(-)) experienced significant cognitive improvements in a 90-day trial of AC-1202.  This additional analysis has shown that specific genotype combinations of E4(-), IDE and IL1B produced additive improvements in cognitive performance.  

Alzheimer's patients who carried combinations of common variants in IDE, APOE and IL1B showed as much as a 7 point increase in cognitive function as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), one of the most widely used scales for anti-dementia drugs in the US.  Changes in the ADAS-cog scores of more than 3-4 points are generally recognized as being clinically meaningful.  Since the specific variations in the genes for IDE and IL1B are commonly observed in the AD population, the number of patients who are likely to experience a heightened therapeutic benefit from Axona should be significant.

This result was particularly surprising because the majority of participants in the study were already taking one or more approved Alzheimer's disease medications. "More than two dozen clinical trials have demonstrated that certain therapies offer clear genotype dependent clinical improvements," commented Dr. Judes Poirier of McGill University.  Dr. Poirier is internationally renowned for his works on the role of apolipoprotein E in the normal and injured brain, and in the genetics of Alzheimer's disease.  According to Dr. Poirier, "this study takes this notion to the next level, linking multiple genetic risk factors to significant therapeutic response in a state-of-the-art, randomized, double-blind, placebo controlled study in mild-to-moderate Alzheimer's disease."

Alzheimer's disease is characterized by decreases in the brain's ability to metabolize glucose, a well recognized condition known as hypometabolism.  Since glucose is the predominant fuel used by the brain, disruptions in glucose metabolism are associated with cognitive impairment.  Axona, a medical food product taken once daily, overcomes this deficiency by providing the brain with ketone bodies, an alternative fuel source that results in improved cognition.  

Dr. Richard Isaacson, Associate Professor of Clinical Neurology at the University of Miami Miller School of Medicine and author of the book "Alzheimer's Treatment / Alzheimer's Prevention: A Patient and Family Guide" also finds these results encouraging.  Dr. Isaacson explains that "clinicians have been struggling to understand why certain patients with Alzheimer's disease may preferentially respond to one therapy, while other patients will not respond.  This exploratory study is important in that it takes the first steps toward understanding how specific genes may influence the response to ketosis therapy, and improve our ability to address glucose hypometabolism in the brain."

 The title of the article is "Pharmacogenetic analysis of the effects of polymorphisms in APOE, IDE and IL1B on a ketone body based therapeutic on cognition in mild to moderate Alzheimer's disease; a randomized, double-blind, placebo-controlled study" and is freely available at (http://www.biomedcentral.com/1471-2350/12/137).

About Alzheimer's disease

AD significantly impacts millions of family members and other caregivers – mentally, physically and financially. The national Family Caregiver Alliance estimates that approximately 80 percent of caregivers provide unpaid assistance seven days a week. With the lack of innovative new medications for AD, both patients and caregivers are seeking alternatives to improve quality of life.

About Axona®

Axona is a first-in-class medical food for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's disease. Dispensed by prescription, Axona targets the metabolic deficiencies and imbalances associated with Alzheimer's disease by providing an alternative energy source for brain cells. With simple administration and once-a-day convenience, Axona is complementary to current Alzheimer's disease therapies.  For more information about Axona, please visit www.about-axona.com or contact a doctor who is familiar with the product.

About Accera, Inc.  

Accera, Inc. is a privately held commercial-stage cognitive health 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.

For more information about Accera, please visit www.accerapharma.com.

Contacts:
Accera, Inc.
Samuel Henderson
Vice president of Research and Development
shenderson@accerapharma.com

Tiberend Strategic Advisors, Inc.
(212) 827-0020
Andrew Mielach
amielach@tiberend.com
or
Madeleine Desmond
mdesmond@tiberend.com


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SOURCE Accera, Inc.
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