Axonyx to Release Additional Results of Phase III Clinical Trial for Phenserine in Alzheimer's Disease.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) today reported additional detailed information from its first Phase III clinical trial 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 with Phenserine (PT), 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 top line outcome was announced by the Company on February 7, 2005. Although Phenserine demonstrated trends toward efficacy in the primary efficacy variables, no statistically significant differences between the efficacy of the active and placebo groups were observed in areas of cognition cognition Act or process of knowing. Cognition includes every mental process that may be described as an experience of knowing (including perceiving, recognizing, conceiving, and reasoning), as distinguished from an experience of feeling or of willing. , global function, behaviour, and activities of daily living. These additional results from the Company's 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 trial will be presented on Saturday, March 12, 2005 at the 7th International Conference on Alzheimer's and Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. in Sorrento, Italy. The Phase III trial involved 375 patients from 11 different clinical sites in Austria, Croatia, Spain and the United Kingdom. After being diagnosed with probable AD, patients were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to receive placebo, Phenserine 10mg twice daily or 15mg twice daily, for a period of 6 months. The primary efficacy parameters were the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog) and the Clinical Interview Based Impression of Change with caregiver care·giv·er n. 1. An individual, such as a physician, nurse, or social worker, who assists in the identification, prevention, or treatment of an illness or disability. 2. input (CIBIC CIBIC Clinician Interview Based Impression of Change +). Additional study endpoints included the Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL) and the Neuropsychiatric neu·ro·psy·chi·a·try n. The medical study of disorders with both neurological and psychiatric features. neu Inventory (NPI NPI National Provider Identifier, see there ). Results for these efficacy parameters are summarized in the following table. None of the active treatment/placebo differences achieved statistical significance.
Mean Changes from Baseline in Study Endpoints
(+/- 1 Standard Errors)(a)
Endpoint Placebo PT 10mg PT 15mg
------------------------------------ --------------- ---------------
Unmodified ADAS cog 0.35 (+/-1.0) -0.55 (+/-0.75) -0.30 (+/-0.75)
------------------------------------ --------------- ---------------
CIBIC+ 3.82 (+/-0.13) 3.73 (+/-0.08) 3.63 (+/-0.08)
------------------------------------ --------------- ---------------
Modified ADAS cog 0.70 (+/-1.2) -0.50 (+/-1.0) -0.40 (+/-1.0)
------------------------------------ --------------- ---------------
NPI/10 -1.5 (+/-0.80) -0.7 (+/-0.6) -0.2 (+/-0.6)
------------------------------------ --------------- ---------------
NPI/Distress -1.10 (+/-0.45) -0.55 (+/-0.30) -0.35 (+/-0.30)
------------------------------------ --------------- ---------------
ADCS- ADL -0.1 (+/-1.0) 1.5 (+/-0.7) 0.2 (+/-0.7)
------------------------------------ --------------- ---------------
(a)ITT= Intention to Treat Analysis (end of study analysis)
Adverse events were monitored during the study and incidence rates
above 2% of the total number of patients are represented in the
following table:
Placebo PT 10mg PT 15mg
(n=76) (n=150) (n=149)
------------------------------------------------ --------- ---------
Any Adverse Event 36 (47.4) 95 (63.3) 86 (57.7)
------------------------------------------------ --------- ---------
Death 1 (1.3) 2 (1.3) 0 (0)
------------------------------------------------ --------- ---------
Serious Adverse Event 2 (2.6) 9 (6.0) 9 (6.0)
------------------------------------------------ --------- ---------
Adverse Event Leading to
Discontinuation 1 (1.3) 15 (10.0) 17 (11.4)
------------------------------------------------ --------- ---------
Drug-related Adverse Event 13 (17.1) 48 (32.0) 47 (31.5)
------------------------------------------------ --------- ---------
The profile of the serious adverse events occurring in the trial
is represented in the following table:
Placebo PT 10mg PT 15mg
(n=76) (n=150) (n=149)
---------------------------------------------------- ------- -------
Pneumonia 1 (1.3) 3 (2.0) 0 (0.0)
---------------------------------------------------- ------- -------
Cardiac Failure 0 (0.0) 3 (2.0) 0 (0.0)
---------------------------------------------------- ------- -------
Gastrointestinal Upset 0 (0.0) 0 (0.0) 1 (0.7)
---------------------------------------------------- ------- -------
Vomiting 0 (0.0) 1 (0.7) 1 (0.7)
---------------------------------------------------- ------- -------
Pulmonary Congestion 0 (0.0) 1 (0.7) 1 (0.7)
---------------------------------------------------- ------- -------
Urinary Tract Infection 0 (0.0) 2 (1.3) 0 (0.0)
---------------------------------------------------- ------- -------
Pyrexia 0 (0.0) 1 (0.7) 1 (0.7)
---------------------------------------------------- ------- -------
Adverse Events Occurring in Greater than 2% of Patients:
Placebo PT 10mg PT 15mg
(n=76) (n=150) (n=149)
---------------------------------------------- --------- ---------
Nausea 1 (1.3) 18 (12.0) 22 (14.8)
---------------------------------------------- --------- ---------
Vomiting 1 (1.3) 8 (5.3) 12 (8.1)
---------------------------------------------- --------- ---------
Headache 0 (0.0) 10 (6.7) 10 (6.7)
---------------------------------------------- --------- ---------
Vertigo 3 (3.9) 3 (2.0) 8 (5.4)
---------------------------------------------- --------- ---------
Abdominal pain upper 2 (2.6) 6 (4.0) 7 (4.7)
---------------------------------------------- --------- ---------
Diarrhoea 0 (0.0) 5 (3.3) 6 (4.0)
---------------------------------------------- --------- ---------
Dizziness 2 (2.6) 3 (2.0) 5 (3.4)
---------------------------------------------- --------- ---------
Atrial fibrillation 2 (2.6) 1 (0.7) 5 (3.4)
---------------------------------------------- --------- ---------
Tachycardia 0 (0.0) 2 (1.3) 4 (2.7)
---------------------------------------------- --------- ---------
Depression 0 (0.0) 2 (1.3) 4 (2.7)
---------------------------------------------- --------- ---------
Bronchitis acute 0 (0.0) 2 (1.3) 3 (2.0)
---------------------------------------------- --------- ---------
Constipation 1 (1.3) 3 (2.0) 3 (2.0)
---------------------------------------------- --------- ---------
Insomnia 1 (1.3) 3 (2.0) 3 (2.0)
---------------------------------------------- --------- ---------
Lymphopaenia 1 (1.3) 2 (1.3) 3 (2.0)
---------------------------------------------- --------- ---------
Anaemia 0 (0.0) 3 (2.0) 2 (1.3)
---------------------------------------------- --------- ---------
Pyrexia 1 (1.3) 6 (4.0) 2 (1.3)
---------------------------------------------- --------- ---------
UTI 1 (1.3) 7 (4.7) 2 (1.3)
---------------------------------------------- --------- ---------
RTI 0 (0.0) 5 (3.3) 1 (0.7)
---------------------------------------------- --------- ---------
Oedema peripheral 0 (0.0) 3 (2.0) 1 (0.7)
---------------------------------------------- --------- ---------
Cardiac failure 1 (1.3) 4 (2.7) 0 (0.0)
---------------------------------------------- --------- ---------
Pneumonia 1 (1.3) 3 (2.0) 0 (0.0)
---------------------------------------------- --------- ---------
Viral infection 0 (0.0) 3 (2.0) 0 (0.0)
---------------------------------------------- --------- ---------
Agitation 0 (0.0) 3 (2.0) 0 (0.0)
---------------------------------------------- --------- ---------
The current study indicates that Phenserine is generally well tolerated in patients with probable AD patients, with an adverse event profile similar to that of currently marketed therapies. "Axonyx has halted additional patient recruitment for the ongoing phase III clinical trials in order to evaluate the planned Phenserine clinical development program," stated Gosse Bruinsma, M.D., President and Chief Executive Officer of Axonyx. "This decision was taken following recommendations from our Scientific Advisory Board and Safety Steering Committee steer·ing committee n. A committee that sets agendas and schedules of business, as for a legislative body or other assemblage. steering committee Noun , as well as the Company's desire to examine opportunities that could optimise optimise - To perform optimisation. further Phenserine development." The AX-CL-06a clinical phase IIb study of Phenserine's effects on beta-amyloid is continuing. About Phenserine Phenserine is a highly selective acetylcholinesterase acetylcholinesterase /ac·e·tyl·cho·lin·es·ter·ase/ (AChE) (-ko?li-nes´ter-as) an enzyme present in the central nervous system, particularly in nervous tissue, muscle, and red cells, that catalyzes the hydrolysis of acetylcholine to (AChE) inhibitor inhibitor /in·hib·i·tor/ (in-hib´i-tor) 1. any substance that interferes with a chemical reaction, growth, or other biologic activity. 2. that binds with an enzyme that is responsible for the breakdown of 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). important in memory and cognition. Unlike other AChE inhibitors, which only suppress To stop something or someone; to prevent, prohibit, or subdue. To suppress evidence is to keep it from being admitted at trial by showing either that it was illegally obtained or that it is irrelevant. the activity of this 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 to be a cause of brain cell death in Alzheimer's disease. 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 . This press release may contain forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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. . Axonyx cannot assure that the Phase IIb and/or other ongoing Phase III clinical trials, amendments thereto there·to adv. 1. To that, this, or it. 2. Archaic In addition to that; furthermore. thereto Adverb Formal 1. to that or it 2. or others, if any, with Phenserine will prove successful, that the safety and efficacy profile of Phenserine exhibited in the previous small Phase II and Phase III trials will remain the same, be better or worse in future clinical trials, if any, that the preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. results related to the regulation of beta-APP will be substantiated by the Phenserine Phase IIb clinical trial and that Phenserine will be able to slow the progression of Alzheimer's disease, that the Phase IIb clinical trial data will differentiate Phenserine from the currently marketed drugs, that any efficacy and safety results of the Phase III trial program, if pursued, will prove pivotal, that Axonyx will obtain the necessary financing to complete the Phenserine or other development programs, that the Company's development work on Phenserine 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, that the results of a Phase III program will allow Phenserine to be approved by 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. , that the FDA will grant marketing approval for Phenserine, that if Phenserine is approved by the FDA, it will prove competitive in the market, and that Axonyx will obtain licensing or corporate partnership agreements that will enable acceleration of the development of and optimize optimize - optimisation marketing opportunities for, Phenserine, or that Axonyx will be able to advance any of its other potential memory enhancing compounds toward IND status. 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 here·of adv. Of this. hereof Adverb Formal or law of or concerning this Adv. 1. hereof - of or concerning this; "the twigs hereof are physic" or to reflect the occurrence of unanticipated events. |
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