Navigation Links
Accera 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
Date:8/12/2009

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).

"Accera has taken a novel approach to Alzheimer's therapy with the development of Axona," said Samuel Henderson, Ph.D., executive director of research at Accera and lead author of the paper. "Publication of our findings confirms our earlier pre-clinical and clinical findings which show that using ketone bodies can be an effective and safe method to approach this devastating disease."

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.

The 90-day, randomized, double-blind, placebo-controlled, parallel-group study, evaluated the effect of daily dosing of AC-1202 in patients diagnosed with mild-to-moderate Alzheimer's disease. The study was conducted in 152 patients at 23 clinical sites throughout the United States. The study examined the effects of AC-1202 on performance in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog). Notably, participants in the study were allowed to remain on their current Alzheimer's disease medications and did not have to alter their diets in any way. Approximately 80% of the participants were taking one or more Alzheimer's disease drugs.

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 impressive safety and efficacy data provide positive validation for Accera's Axona (AC-1202)," said Steven H. Ferris, Ph.D., professor of psychiatry and director at New York University Alzheimer's Disease Center and Chairman of the Accera medical advisory board, who reviewed the clinical findings. "Now available, physicians can prescribe Axona to their Alzheimer's patients as an adjunctive therapy to their existing Alzheimer's medical protocol."

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

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. Accera is engaged in the research, development and commercialization of other clinical applications for Axona in acute and chronic neurodegenerative diseases. For more information about Accera, please visit www.accerapharma.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.

    Contacts:

    Accera, Inc.
    Steve Orndorff, Ph.D.
    President and CEO
    (303) 999-3700
    sorndorff@accerapharma.com

    Richard Lewis Communications, Inc.
    Andrew Mielach
    (212) 827-0020
    amielach@rlcinc.com


'/>"/>
SOURCE Accera, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Accera, Inc. to Present at the 4th Annual BIO Investor Forum
2. Accera, Inc. Names William T. Poncy Vice President of Commercial Development
3. Accera, Inc. Completes $35 Million Series C Financing
4. Accera, Inc. Sponsors Alzheimers Associations 2009 ICAD Conference
5. Video: Accera Launches Axona(TM), First Medical Food Therapy to Help Manage Mild-to-Moderate Alzheimers Disease
6. Dr. Thomas Werner Elected to Accera, Inc.s Board of Directors
7. Accera, Inc. to Present at Upcoming Investor Conferences
8. Accera, Inc. Launches Neuera Pharmaceuticals, Inc.
9. Accera, Inc. to Support the Alzheimers Foundation of Americas National Memory Screening Day Through On-line Awareness Effort
10. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
11. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... SAN DIEGO , Dec. 8, 2016 /PRNewswire-USNewswire/ ... treatments for congestive heart failure and type 2 ... license for a novel adeno-associated virus (AAV) vector ... Kay , M.D., Ph.D., at Stanford University. The ... of its paracrine gene therapy product pipeline. ...
(Date:12/8/2016)... December 8, 2016 Oxford Gene ... customisable SureSeqâ„¢ NGS panel range with the launch of the ... cost-effective study of variants in familial hypercholesterolemia (FH). The panel ... detection on a single small panel and allows customisation by ... includes all exons for LDLR , P ...
(Date:12/8/2016)... , ... December 08, 2016 , ... This CAST literature ... for biotech crops. The authors focus on the economic effects in countries that are ... of new biotech crops and the resultant risk of low level presence (LLP) puts ...
(Date:12/8/2016)... Dec. 8, 2016 Eutilex Co. Ltd. today ... (US $18.9M) Series A financing. This financing round included ... Venture and SNU Bio Angel. This new funding brings ... KRW (US $27.7M) since its founding in 2015. ... the development and commercialization of its immuno-oncology programs, expand ...
Breaking Biology Technology:
(Date:11/14/2016)... CLARA, Calif. , Nov. 14, 2016 ... the biometric identification market, Frost & Sullivan ... Frost & Sullivan Award for Visionary Innovation ... player in the biometric identification market by ... multi-modal verification solution for instant, seamless, and ...
(Date:6/22/2016)... American College of Medical Genetics and Genomics was once again ... of the fastest-growing trade shows during the Fastest 50 Awards ... Las Vegas . Winners are ... of the following categories: net square feet of paid exhibit ... 2015 ACMG Annual Meeting was ranked 23 out of 50 ...
(Date:6/22/2016)... , June 22, 2016 On Monday, ... call to industry to share solutions for the Biometric ... U.S. Customs and Border Protection (CBP), explains that CBP ... are departing the United States , ... and to defeat imposters. Logo - ...
Breaking Biology News(10 mins):