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Accera, Inc. and University of Miami Announce Collaboration to Study Axona® for Cognitive Impairment in Patients with Multiple Sclerosis


4/9/2013 9:34:58 AM

BROOMFIELD, Colo., April 9, 2013 /PRNewswire/ -- Accera, Inc., a privately-held, commercial-stage, healthcare company focused on the discovery and development of innovative clinical applications to address acute and chronic neurodegenerative diseases, announced today a study in collaboration with the University of Miami Miller School of Medicine. The study will examine the effects of Accera's medical food, Axona, on cognitive impairment in patients with multiple sclerosis (MS). Axona is a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease (AD). Drs. Melissa Ortega and Heather Katzen, two researchers at the Miller School, will serve as the primary investigators of the study. The project will be funded by Fast Forward, LLC, a nonprofit organization established by the National Multiple Sclerosis Society.

More than 2.1 million people are affected by MS worldwide, and cognitive problems commonly occur in individuals with MS. Symptoms vary in severity and may have a negative impact on relationships, work and quality of life. There are few treatment options available and there is a pressing need for new interventions for cognitive impairment in MS. The UM Miller School of Medicine and Accera, with support from Fast Forward, LLC, will be testing Axona as a unique strategy for improving cognitive function in individuals with MS to address this disabling symptom.

Axona, made from special fats, produces ketones, which can provide an alternative energy source for brain cells. While typically the human brain relies on glucose as an energy source, research shows that individuals with AD fail to metabolize glucose properly. The decrease in glucose use correlates with cognitive impairment associated with the disease. In clinical trials, Axona was associated with cognitive improvement in people with mild to moderate AD. Previous research suggests there may also be flaws in how glucose is metabolized in the brains of individuals with MS. The notion that these metabolic abnormalities may be contributing to cognitive dysfunction in MS is what led Dr. Ortega, a neurologist who specializes in MS, to consider whether Axona may provide a therapeutic strategy to treat MS-related cognitive problems. To investigate whether Axona can help restore cognitive function in MS patients, this double-blind, randomized, placebo-controlled study will enroll 158 MS patients at the UM Miller School of Medicine MS Center over the next three years who have experienced cognitive problems.

"We are very excited about this project," said Holger Kunze, CEO at Accera. "This collaboration fits well with Accera's mission to help patients with neurological disorders by addressing metabolic deficiencies common in these disease states."

About Axona
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. For more information about Axona, please visit www.about-axona.com.

About Medical Foods
A medical food is a product intended for the clinical dietary management of a disease or condition for which distinctive nutritional requirements are established scientifically. Medical foods are intended to be used under physician supervision, must be composed of approved food ingredients or generally recognized as safe and must comply with FDA regulations and guidelines that pertain to labeling, product claims and manufacturing.

About Accera, Inc.
Accera, Inc. is a privately held commercial-stage biotechnology company that developed and now markets Axona in the US. Accera is engaged in the research, development and commercialization of other clinical applications for Axona and AC-1204 in acute and chronic neurodegenerative diseases. For more information about Accera, please visit www.accerapharma.com.

About University of Miami
Founded in 1952 as Florida's first accredited medical school, the University of Miami Leonard M. Miller School of Medicine provides medical staff for the nationally renowned University of Miami/Jackson Memorial Medical Center and University of Miami Hospital. University of Miami Hospital is the flagship facility of UHealth, which also includes two additional University-owned hospitals: Sylvester Comprehensive Cancer Center and Anne Bates Leach Eye Hospital, home to the top-ranked Bascom Palmer Eye Institute. Our affiliated hospitals on the medical campus include Jackson Memorial Hospital, Holtz Children's Hospital, and the Miami VA Medical Center. http://www.med.miami.edu

About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Fast Forward, LLC
Fast Forward, LLC, established by the National Multiple Sclerosis Society as part of a comprehensive approach to MS research and treatment, focuses on speeding promising research discoveries towards commercial drug development. Fast Forward accelerates the development of treatments for MS by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS. For more information, please visit www.fastforward.org.

About the National Multiple Sclerosis Society
The National MS Society addresses the challenges of each person affected by MS. To fulfill this mission, the Society funds cutting-edge research, drives change through advocacy, facilitates professional education, collaborates with MS organizations around the world, and provides programs and services designed to help people with MS and their families move forward with their lives. In 2012 alone, the Society invested $43 million to support 350 research projects around the world while providing programs and services that assisted more than one million people. The Society is dedicated to achieving a world free of MS. Join the movement at www.nationalMSsociety.org.

For media:
Tiberend Strategic Advisors, Inc.
Andrew Mielach and Claire Sojda
amielach@tiberend.com; 212-375-2694
csodja@tiberend.com; 212-375-2686

SOURCE Accera, Inc.



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