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ACADIA Pharmaceuticals Announces Accelerated Timing of ACP-103 Phase II Trial in Patients with Schizophrenia; Top-Line Results for Complete 400-Patient Study Expected in Q1 2007.


SAN DIEGO -- ACADIA Acadia (əkā`dēə), Fr. Acadie, region and former French colony, E Canada, encompassing modern Nova Scotia but also New Brunswick, Prince Edward Island, and coastal areas of E Maine. After an abortive 1604 settlement of St.  Pharmaceuticals Inc. (Nasdaq:ACAD ACAD Academy
ACAD Academic
ACAD AutoCAD (design/drafting development software by Autodesk)
ACAD Acadia National Park (US National Park Service)
ACAD Atherosclerotic Coronary Artery Disease
), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for 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
, today provided an update on the timing of its Phase II adjunctive therapy adjunctive therapy Medtalk A therapeutic maneuver(s) with an ancillary role in treating a disease by ↓ M&M, but not part of the immediate therapy required to stabilize the Pt. Cf Adjuvant therapy.  trial with ACP-103 in patients with schizophrenia. ACADIA reported that enrollment in the clinical trial is significantly ahead of schedule, which should enable the company to report top-line results for the complete 400-patient clinical trial during the first quarter of 2007, ahead of earlier expectations. Given the rapid enrollment and opportunity to expedite results for the complete study, ACADIA will no longer perform an interim analysis based on the first 200 patients, which had been planned to be conducted by the end of 2006.

The Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 is a multi-center, double-blind, placebo-controlled study designed to evaluate the ability of ACP-103 when used adjunctively with each of risperidone, an atypical antipsychotic drug, and haloperidol haloperidol /hal·o·peri·dol/ (hal?o-per´i-dol) an antipsychotic agent of the butyrophenone group with antiemetic, hypotensive, and hypothermic actions; used especially in the management of psychoses and to control vocal utterances and , a typical antipsychotic drug, to provide an improved therapy for patients with schizophrenia. The trial is designed to enroll a total of 400 patients with schizophrenia. ACADIA previously announced that it had enrolled 200 patients in the study by mid-2006, and over 350 patients have been enrolled to date. The primary endpoint of the study is antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic  efficacy as measured by the Positive and Negative Syndrome Scale (PANSS PANSS Positive & Negative Symptom Scale, see there ), an industry standard rating scale used in schizophrenia trials.

"We are pleased with the rapid rate of enrollment in our ACP-103 Phase II adjunctive therapy trial and now expect to complete enrollment early in the fourth quarter," said Roger G. Mills, M.D., ACADIA's Executive Vice President, Development. "This enables us to expedite the completion of the trial and makes the interim analysis unnecessary. We believe that adjunctive therapy with ACP-103 may result in both better efficacy and lower side effects Side effects

Effects of a proposed project on other parts of the firm.
 than current treatments, thereby providing the potential to significantly improve the therapy for patients suffering from schizophrenia and related neuropsychiatric neu·ro·psy·chi·a·try  
n.
The medical study of disorders with both neurological and psychiatric features.



neu
 disorders."

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. ACADIA currently has five Phase II-stage clinical programs as well as a portfolio of preclinical and discovery assets directed at diseases with large unmet medical needs, including schizophrenia, Parkinson's disease, sleep maintenance insomnia, and neuropathic pain. All of the drug candidates in ACADIA's product pipeline emanate from discoveries made using its proprietary drug discovery platform. ACADIA's corporate headquarters is located in San Diego, California “San Diego” redirects here. For other uses, see San Diego (disambiguation).
San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951.
 and it maintains research and development operations in both San Diego and Malmo, Sweden.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the progress of and benefits to be derived from ACADIA's drug development program for the adjunctive use of ACP-103 for schizophrenia and other neuropsychiatric disorders and the anticipated schedule for ACADIA to release results from its current Phase II trial. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in patient enrollment in clinical trials, and drug development and commercialization. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2005 as well as other subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Clinical report
Date:Sep 25, 2006
Words:660
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