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Accera, Inc. Announces Open-Label Data from Phase II Study in,Alzheimer's Disease at International Conference on Prevention of,Dementia

BROOMFIELD, Colo., June 11, 2007 /PRNewswire/ -- Accera, Inc. today is presenting data from an open-label extension of its Phase IIb clinical trial of AC-1202 (Ketasyn) in Alzheimer's disease (AD) at the Alzheimer's Association's International Conference on Prevention of Dementia in Washington, D.C. Consistent with the findings of earlier clinical and preclinical studies, AC-1202 was shown to be safe and to significantly improve the memory and cognition of subjects of a particular pharmacogenomic profile.

The randomized, double-blinded, placebo-controlled Phase IIb trial evaluated 152 subjects that had previously been diagnosed with mild to moderate AD at 25 centers across the United States. AC-1202 was administered once daily, and most patients continued to take their other AD drugs such as acetylcholinesterase inhibitors. Following three months of treatment and a two-week washout, eligible subjects were given the opportunity to receive AC- 1202 in a six-month open-label extension study. The main clinical outcome for efficacy was improvement in the AD Assessment Scale-Cognitive (ADAS-Cog) score, which measures memory and other aspects of cognitive performance.

In the double-blind phase of the clinical study the ADAS-Cog scores of the AC-1202-treated ApoE4(-) population improved 3.5 points in twelve weeks (p=0.01) compared to the placebo group, and statistically significant improvement was seen in just 45 days. ApoE4(-) subjects who also exhibited a genetic variation that affects glucose regulation showed a 5-point improvement in ADAS-Cog scores compared to placebo, providing further insight into the disease.

As in the double-blind phase of the study, the most profound effect was seen in subjects not expressing the ApoE4 genotype, a genetic risk factor for AD. ApoE4(-) subjects represent the other half of Alzheimer's patients. ApoE4(-) subjects who started taking AC-1202 on the open-label e
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