Axonyx Reports Statistically Significant Result for Phenserine in Alzheimer's Disease; Additional Analysis Results from Curtailed Phase III Clinical Trials.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Axonyx Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : AXYX) reports today the results of an additional analysis of a subgroup of patients from its two curtailed Phase III clinical trials Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the (AX-CL-09/010) with Phenserine, in development for mild to moderate Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. (AD). The subgroup of patients, who received Phenserine 15mg twice daily, demonstrated a statistically significant benefit over placebo as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), when treated for more than 12 weeks. Additionally, this subgroup showed a positive trend towards improvement in the Clinical Interview Based Impression of Change (CIBIC CIBIC Clinician Interview Based Impression of Change +) test, which approached statistical significance. There were no unexpected safety or tolerability concerns associated with Phenserine treatment. This analysis was undertaken in addition to the previously announced results of the primary pre-defined statistical analysis. While additional clinical trials would be required to further confirm the results of this additional analysis, the Company believes that they support its stated position that higher doses of Phenserine could potentially be efficacious ef·fi·ca·cious adj. Producing or capable of producing a desired effect. See Synonyms at effective. [From Latin effic in treating the signs and symptoms of mild to moderate AD in future potential Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials of 26 weeks duration. On September 20, 2005, the Company announced the top line results from its primary efficacy analysis of all patients that participated in the curtailed Phase III clinical trials; this analysis did not demonstrate a statistically significant benefit associated with Phenserine over placebo after 12 weeks of treatment in either the ADAS-cog or CIBIC+, the primary efficacy endpoints for the study. At that time, the Company indicated that it would continue to evaluate the Phenserine program. On November 7, 2005, the Company indicated it would not commit further resources to the development of Phenserine and would seek a partner for the compound. This additional analysis was recently completed as part of the program to identify a partner for the further development of Phenserine. The analysis included 182 patients who received Phenserine treatment or placebo for more than 12 weeks and up to 26 weeks of treatment. The statistically significant benefit was based on the ADAS-cog test; one of the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved measurements of efficacy in Alzheimer's disease clinical trials. The improvement in the CIBIC+ test, another approved efficacy endpoint, for the 15mg twice daily group approached statistical significance compared to the placebo group. The patients who received Phenserine 10mg twice daily did not show a statistically significant benefit compared to placebo. Details of the secondary analysis results are provided in the chart below. For the ADAS-cog, more negative values indicate greater improvement of cognition. For CIBIC+ lower values indicate greater improvement.
Mean Changes from Baseline to Last Visit in the Post Week 12 Patient
Subgroup
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15-mg Mean Difference
Endpoint Twice Daily Placebo 15mg vs. Placebo P - value(c)
n = 54 n = 66 (+/-95% Confidence Intervals)
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ADAS-cog(a) -3.18 -0.66 -2.52 (-4.92 to -0.12) 0.0296
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CIBIC+(b) 3.59 3.95 -0.36 (-0.76 to 0.04) 0.0568
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a) Ranked ANCOVA model with centre and baseline covariates.
b) Cochran-Mantel-Haenzsel test incorporating rank scores.
c) Statistical significance is defined as a P value of 0.05 or
less.
Phenserine is a highly selective acetylcholinesterase inhibitor acetylcholinesterase inhibitor n. See cholinesterase inhibitor. (AChE-I) that breaks down a neurotransmitter neurotransmitter, chemical that transmits information across the junction (synapse) that separates one nerve cell (neuron) from another nerve cell or a muscle. Neurotransmitters are stored in the nerve cell's bulbous end (axon). in the brain important in memory and cognition. Unlike other AChE-I's which only suppress the activity of the enzyme, Phenserine has been shown to have two mechanisms of action: (1) the inhibition of the AChE enzyme, and (2) in preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. the inhibition of the synthesis of A beta, the protein in the brain that is thought by many to be a potential cause of Alzheimer's disease and its progression. About Axonyx Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in the acquisition and development of proprietary pharmaceutical compounds for the treatment of Central Nervous System disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . The Company currently has three compounds in development for Alzheimer's disease, namely Phenserine - a potential symptomatic and disease progression treatment of mild to moderate Alzheimer's Disease (AD), Posiphen(TM) - a potential disease progression treatment for AD now in Phase I, and BisNorCymcerine (BNC (hardware) BNC - A connector for coaxial cable such as that used for some video connections and RG58 "cheapernet" connections. A BNC connector has a bayonet-type shell with two small knobs on the female connector which lock into spiral slots in the male connector when it is twisted ) - a potential symptomatic treatment Symptomatic treatment is any medical therapy of a disease that only affects its symptoms, not its cause, i.e., its etiology. It is usually aimed at reducing the signs and symptoms for the comfort and well-being of the patient, but it also may be useful in reducing organic of severe AD now in pre-Investigational New Drug (IND) stage. This press release may contain forward-looking statements or predictions. These statements represent our judgment to date, and are subject to risks and uncertainties that could materially affect the Company, including those risks and uncertainties described in the documents Axonyx files from time to time with the SEC, specifically Axonyx's annual report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. . Specifically, with respect to our drug candidates Phenserine, Posiphen(TM) and BisNorCymcerine, Axonyx cannot assure that: any preclinical studies or clinical trials, whether ongoing or conducted in the future, will prove successful, and if successful, that the results can be replicated; safety and efficacy profiles of any of its drug candidates will be established, or if established, will remain the same, be better or worse in future clinical trials, if any; pre-clinical results related to cognition and the regulation of beta-APP will be substantiated by ongoing or future clinical trials, if any, or that any of its drug candidates will be able to improve the signs or symptoms of their respective clinical indication or slow the progression of Alzheimer's disease; any of its drug candidates will support an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any filing or its equivalent, will be approved by the FDA or its equivalent, or if approved, will prove competitive in the market; or that Axonyx will have or obtain the necessary financing to support its drug development programs. Axonyx cannot assure that it will be successful with regard to identifying a (sub-) licensing partner for any of its compounds. Axonyx undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. |
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