PRESS RELEASE
Accera Initiates Phase 2 Trial in Age Associated Memory Impairment
Patient enrollment completed ahead of schedule
Broomfield, CO, August 23, 2006 - Accera, Inc., a drug development company focused on Alzheimer's disease and related neurodegenerative diseases, announced it has initiated a multi-center, placebo-controlled Phase IIa study of KetasynTM (AC-1202) for the treatment of Age Associated Memory Impairment (AAMI).
Steve A. Orndorff, President and CEO of Accera, said the Phase II trial will evaluate the safety and effectiveness of KetasynTM in improving short term memory in patients aged 50 - 85. Treatment of AAMI has a potential worldwide market estimated at more than $2 billion annually for which there is no approved treatment today.
In a related development, the Company announced that patient enrollment was completed within 3 weeks of initiation of the study, more than two months earlier than anticipated. More than 150 subjects have entered the 90 day study which is being conducted at six clinical sites in the U.S. Subjects will receive either KetasynTM or placebo, and all will be assessed periodically through a comprehensive battery of memory and cognition tests.
Detailed information on the Phase IIa study is available at http://clinicaltrials.gov/ct/show/NCT00355550?order=1. The Company expects results of the AAMI trial in the first half of 2007.
"The overwhelming patient response to this trial is evidence of the tremendous unmet medical need for Age Associated Memory Impairment and the efficiency of our clinical development program," said Orndorff. "This study is very complementary to our recently completed Phase IIb trial on Alzheimer's disease by demonstrating the efficacy of KetasynTM in the earliest stages of memory loss."
The Company recently completed a multi-center, placebo-controlled Phase IIb clinical trial of KetasynTM in more than 130 patients with mild-to-moderate Alzheimer's disease at 25 clinical sites throughout the U.S. The final results of the study will be available by the end of this year. Meanwhile, about 50 patients from this study have entered a six month open-label extension. All patients in this extension are receiving a daily dose of KetasynTM and periodic clinical visits to evaluate safety and efficacy of the study drug. The final results of the open-label extension are due in the first quarter of 2007.
"These trials will provide valuable direction for our clinical development program for KetasynTM and create new opportunities for building value in the Company," added Orndorff.
About KetasynTM (AC-1202)
KetasynTM is a first-in-class therapeutic that targets neuronal cells in the brain and acts to increase mitochondrial activity. Numerous studies have shown that energy metabolism and lipid homeostasis are impaired in neuronal cells within the hippocampal region of the brain where memory and cognition are processed. Research has shown that AC-1202 lowers oxidative stress in the brain while increasing energy metabolism essential for the synthesis of key neurotransmitters and lipids. Preclinical studies of KetasynTM have shown it to be effective in behavioral studies of learning and memory, and a Phase IIa clinical trial demonstrated that it improved certain measures of memory in Alzheimer's disease patients.
About AAMI
Age Associated Memory Impairment generally occurs in people over the age of 50 and is characterized by a decline in memory function relative to young adults that is not due to any coexisting medical or psychiatric condition. The prevalence of AAMI increases with age, occurring in 41% of people aged 50 -59 and increasing to 85% of persons over the age of 80. Today there is no approved therapy for the prevention or treatment of AAMI.
About Accera, Inc.
Accera, Inc. is a privately held, Broomfield, Colorado based biotechnology company focused on developing novel drugs for neurodegenerative diseases. The company's lead product, KetasynTM (AC-1202), is a first-in-class molecule currently in Phase II clinical trials for Alzheimer's disease and Age Associated Memory Impairment. Accera will develop KetasynTM and other small molecule compounds in its pipeline with corporate partners for a range of memory and cognition disorders associated with neurological conditions and aging.
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