PRESS RELEASE
Accera Expands Ongoing KetasynTM Clinical Trial for Alzheimer's Disease
Broomfield, CO, September 8, 2005 - Accera, Inc. announced today that it has received approval to provide Alzheimer's disease patients in its' ongoing Phase IIb clinical trial the opportunity to receive KetasynTM (AC-1202) treatment in a formal open label six-month extension study.
The on-going Phase IIb clinical trial has been conducted as a double-blind placebo-controlled study at more than 15 clinical sites across the U.S. in 100 patients diagnosed with probable mild-to-moderate Alzheimer's disease. All patients that complete the trial will be given the opportunity to receive six months of KetasynTM treatment in an open-label extension study. Both studies will provide safety and efficacy data based upon measures of memory, cognition and global quality of life.
KetaysnTM is a first-in-class therapeutic in clinical development for the treatment of Alzheimer's disease and Age Associated Memory Impairment.
"Patient feedback has indicated a high level of interest in receiving KetasynTM treatment after the original testing period of the Phase IIb trial. We feel it is appropriate to provide all patients with the therapeutic benefits from KetasynTM. At the same time this extension study will generate additional safety and efficacy data from patients on long-term treatment to support the clinical development of this product," said Steve A. Orndorff, Ph.D., President and CEO, Accera, Inc. "We expect the first patients to enter this open label study immediately."
Open label extension studies are often conducted to provide patients with promising therapeutic treatments for diseases with unmet medical needs. Currently, the approved drugs for Alzheimer's disease are largely palliative and work only in a small fraction of the patient population. Extension studies also generate safety and efficacy data to support the approval of a drug by regulatory authorities for chronic use in patients.
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