Evidence for a New Genetic Link to Therapeutic Efficacy for Alzheimer’s Disease

By Prne, Gaea News Network
Monday, July 13, 2009

BROOMFIELD, Colorado -

- Study to be presented at the 2009 International Conference on Alzheimer’s Disease

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.

During this study, patients received daily administration of either AC-1202 or placebo for 90 days, with efficacy assessments performed at Baseline (Day 0), Day 45, Day 90 and after a two week washout from their assigned product on Day 104. In addition, analyses of a number of genotypic markers judged to be relevant to the physiological background of Alzheimer’s disease were also performed.

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.

To further investigate pharmacogenomic responses of AC-1202 in AD, the effects of APOE4 carriage status and a polymorphism (IDE_7) in the insulin degrading enzyme gene (IDE) on ADAS-Cog scores were evaluated over the study course. In addition to degrading insulin, the Ide protein also degrades amyloid beta peptide and has been implicated in playing a role in Alzheimer’s disease.

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.

The combination of the E4(-); IDE_7(C/C)(-) genotype is prevalent in approximately 40% of the AD population, so the number of potential responder patients is substantial.

“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.”

The study results will be presented on Wednesday, July 15 under the title, “Evidence of an Interaction Between APOE and IDE in Ketone Body Therapies in Mild to Moderate Alzheimer’s Disease.” The conference is being held in Vienna, Austria at the Messe Wien Exhibition and Congress Center.

About Axona(TM)

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 ask your physician.

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.

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 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.

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

Contacts: Accera, Inc. Steve Orndorff, Ph.D. President and CEO sorndorff@accerapharma.com Richard Lewis Communications, Inc. +1-212-827-0020 Andrew Mielach, Media amielach@rlcinc.com Cecelia Heer, Investors cheer@rlcinc.com

Source: Accera, Inc.

Steve Orndorff, Ph.D., President and CEO of Accera, Inc., sorndorff at accerapharma.com; or Media, Andrew Mielach, amielach at rlcinc.com, or Investors, Cecelia Heer, cheer at rlcinc.com, both of Richard Lewis Communications, Inc., +1-212-827-0020, for Accera, Inc. / NOTE TO EDITORS: Dr. Henderson and CEO Dr. Steve Orndorff will be available for media interviews during the conference to discuss this genetic marker and these clinical results.

July 22, 2009: 12:38 pm

Thanks for the post, specially for focusing on Alzheimer’s Disease. Yes, brain is the most complex part of our body and it is also the most relevant. Brain diseases like Alzheimer’s Disease is a great challenge for the present neurologists and researchers. Currently this disease cannot be cured completely but I am quite sure that our neurologists and researchers will certainly find a remedy for this strange and disastrous disease.

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