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Accera, Inc. Announces Peer-Reviewed Publication of the Results of its 90-Day Clinical Study of AC-1202 (Axona(TM) ) in Mild to Moderate Alzheimer's Disease


8/12/2009 9:39:35 AM

BROOMFIELD, Colo., Aug. 12 /PRNewswire/ -- Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system (CNS) disorders, announced today publication of a scientific paper in the peer-reviewed journal Nutrition & Metabolism. The paper, entitled "Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer's disease: a randomized, double-blind, placebo-controlled, multicenter trial" suggests that daily administration of AC-1202 (Axona(TM)) can help improve cognition and memory in patients with mild-to-moderate Alzheimer's disease (AD).

Alzheimer's disease is characterized by early and region-specific declines in the brain's ability to metabolize glucose, its main fuel source. Prior clinical evidence suggests that ketones can serve as an alternative energy source for the brain during glucose deprivation. Axona, which was launched as a prescription medical food product in the US in March 2009, is a proprietary formulation of a pharmaceutical-grade medium chain triglyceride (AC-1202) designed to safely elevate serum ketone bodies, thus providing an alternative energy source for the brain. In this Phase IIb trial, AC-1202 was used to determine whether chronic induction of mild ketosis in patients with probable Alzheimer's disease could improve cognition and short term memory performance.

Researchers found that AC-1202 was safe and produced a beneficial trend for the overall subject population and significant cognitive benefits in a predefined analysis of patients who did not carry the epsilon 4 (E4) variant of the apolipoprotein E gene (APOE4). Possession of an APOE4 allele is the major genetic risk factor for development of the most common form of Alzheimer's disease. In addition, there was a significant correlation between improvement in cognition and memory and amount of AC-1202 consumed by APOE4(-) patients, i.e., dosing compliance. This finding suggests that AC-1202 may offer a novel and effective genotype-specific strategy for Alzheimer's disease. Approximately 50% of the general Alzheimer's disease patient population is APOE4(-).

The full peer-reviewed paper may be downloaded at no charge at www.nutritionandmetabolism.com.

About Axona(TM)

Axona is a first-in-class prescription medical food for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's disease. Axona targets the metabolic deficiencies and imbalances associated with Alzheimer's disease by providing ketone bodies as an alternative energy source for brain cells that have defective energy metabolism and can no longer utilize glucose. Axona has been shown to safely improve cognitive function and memory in AD patients and in pre-clinical animal models of dementia. With simple administration and once-a-day convenience, Axona is complementary to current Alzheimer's disease therapies. Axona is a medical food as defined by the Orphan Drug Act and is regulated by the Food and Drug Administration. For more information about Axona, please visit www.about-axona.com or ask your physician.

SOURCE Accera, Inc.

CONTACT: Steve Orndorff, Ph.D., President and CEO of Accera, Inc.,
+1-303-999-3700, sorndorff@accerapharma.com; or Andrew Mielach of Richard
Lewis Communications, Inc., +1-212-827-0020, amielach@rlcinc.com, for
Accera, Inc.

Web site: http://www.accerapharma.com/
http://www.nutritionandmetabolism.com/



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