ANN ARBOR, Mich., June 2, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today positive findings based on further analyses from the clinical study evaluating reaZin along with near-term plans for its Alzheimer's disease program. After reviewing the statistical analysis with the Company's scientific advisors, Adeona intends to conduct another Alzheimer's disease clinical study to evaluate its proprietary zinc-based tablet in patients age 70 and over. In parallel, Adeona intends to make reaZin commercially available as a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer's disease.
After presenting the top-line results in April from the clinical study evaluating reaZin that demonstrated, on average, that the cognitive function (as measured by three standardized cognitive tests) of the patients managed with reaZin remained relatively stable over six months, while the placebo group showed deterioration, Adeona conducted further analyses to determine if certain subgroups in the patient sample benefitted from reaZin more than others.
After analyzing a number of independent variables associated with the patients enrolled in the clinical study on a post-hoc basis, the strongest relationship was found to be between age and cognitive outcomes. Patients in the study ranged from 52 to 86 years of age. Patients in the placebo group, on average, showed age-related cognitive decline - the older the patient, the greater the rate of cognitive decline. In contrast, patients in the reaZin treatment group, on average, showed cognitive stabilization, no matter what their age. Therefore, the older the reaZin treatment patient, the greater the amount of cognitive benefit compared to the placebo patients of the same age.
These observations were supported by an age-related subgroup analysis that showed dosing-compliant patients age 70 and over (approximately the oldest three quartiles of the patients evaluable at the end of the study) demonstrated statistically significant improvements in two of the three cognitive scoring measurements in the reaZin treatment group compared to the placebo group. As presented below, in this subgroup, two of the three standard cognitive measures reached statistical significance (p < 0.05) as determined by the p-values (the average changes in cognitive scores from baseline to 6 months in the treatment group compared to the placebo group). The p-values were as follows:
◦ADAS-Cog - Alzheimer's Disease Assessment Scale - Cognitive Subscale p-value: 0.037
◦CDR-SOB - Clinical Dementia Rating Scale - Sum of Boxes p-value: 0.032
◦MMSE - Mini Mental State Examination p-value: 0.067
Based upon the apparent cognitive benefit observed in these older patients who were managed with reaZin in comparison to patients who received the matching placebo, Adeona is preparing a larger clinical study protocol to evaluate patients diagnosed with mild to moderate Alzheimer's disease who are age 70 and over. It is anticipated that the clinical study will enroll over 100 patients and that the evaluation period will be at least 12 months. The intention is to develop the Company's proprietary zinc-based tablet as a drug (in parallel with making reaZin available as a prescription medical food) and to conduct this new clinical study under an Investigational New Drug (IND) application to be filed with the Food & Drug Administration (FDA).
"The biological availability of zinc is impaired in Alzheimer's disease as evidenced by significantly lower plasma zinc levels and deficiencies of neuronal zinc activities, each of which are further exacerbated with age. The recent clinical study of reaZin showed that the oral treatment is well-tolerated, and there are even trends to benefits in cognitive outcomes over the study period in several readouts. Based on the consistencies in these trends, the prevalence of abnormally low plasma zinc levels in the elderly, and the established detrimental effects of chronic zinc deficiency on cognition, I think it is very reasonable to test for the ability of reaZin to ameliorate cognitive decline in a larger-scale clinical trial," said Ashley I. Bush, M.D., Ph.D., Head of the Oxidation Disorders Laboratory for the Mental Health Research Institute, University of Melbourne and Adeona Scientific Advisory Board member.
"It is well documented that zinc deficiency increases as we age, and we as well as other clinical groups have shown that Alzheimer's patients are more zinc deficient in comparison to age-matched control patients. These observations support our belief that the older an Alzheimer's patient is, the more zinc depleted that patient is, and therefore, it is likely that patient will receive greater cognitive benefit when managed with our proprietary zinc-based tablet," said George J. Brewer, M.D., Senior Vice President of Adeona. "As we are currently witnessing an epidemic of Alzheimer's disease, such that well over 10 million Americans are affected, we are very excited to begin a larger clinical study intended to further demonstrate that reaZin is effective in preventing or slowing the loss of cognition in older Alzheimer's patients and therefore help stem the tide of this epidemic."
Top-Line Results from the Clinical Study Evaluating reaZin
The top-line results from Adeona's clinical study evaluating reaZin for the dietary management of zinc deficiency associated with Alzheimer's disease were presented at the 63rd Annual Meeting of the American Academy of Neurology in April 2011. As prospectively hypothesized, patients administered reaZin demonstrated increased serum zinc levels and decreased serum free copper levels, resulting in statistical significance of the primary outcomes of the clinical study (p < 0.0006). The cognitive function of the placebo group, on average, declined over 6 months in comparison to patients managed with reaZin. The cognitive function trends favoring the patients managed with reaZin were observed in all three standardized cognitive tests utilized in our study and suggest that reaZin may provide an important benefit to the dietary management of zinc deficiency associated with Alzheimer's disease.
reaZin is a proprietary, gastroretentive, sustained release, once-daily oral tablet formulated from zinc (150 mg) and cysteine (100 mg), an amino acid with potent anti-oxidant properties. reaZin was developed by Adeona to achieve the following: 1) the convenience of a once-daily dose, 2) high oral bioavailability (the quantity or fraction of the ingested dose that is absorbed by the body) and 3) superior tolerability which provides the ability to minimize the substantial gastrointestinal side effects and limitations associated with existing oral zinc therapy.
About Adeona Pharmaceuticals, Inc.
Adeona is a pharmaceutical company developing innovative medicines for the treatment of serious central nervous system diseases. The Company's primary strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration. Currently, Adeona is developing, or has partnered the development of, the following product candidates: a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer's disease, and drugs to treat multiple sclerosis, fibromyalgia, Alzheimer's disease and age-related macular degeneration. For more information, please visit Adeona's website at www.adeonapharma.com.