Navigation Links
AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Cognitive Dysfunction in Schizophrenia
Date:12/8/2008

WILMINGTON, Del. and WINSTON-SALEM, N.C., Dec. 8 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) and Targacept, Inc. today announced top-line results from a Phase IIb clinical trial of AZD3480 (TC-1734) conducted by AstraZeneca in cognitive dysfunction in schizophrenia (CDS), known as the HALO trial.

AZD3480 did not meet the trial's criteria for statistical significance on the primary endpoints, improvement on various cognitive domains measured by the IntegNeuro computerized test battery. AZD3480 was generally well tolerated in the study. AstraZeneca and Targacept do not expect to progress AZD3480 into Phase III studies for CDS.

In addition to the HALO trial, AstraZeneca and Targacept previously announced top-line results from a Phase IIb study of AZD3480 in mild to moderate Alzheimer's disease, known as the Sirocco trial, and are currently evaluating AZD3480 in a Phase II exploratory study in attention deficit/hyperactivity disorder (ADHD) in adults. A decision by AstraZeneca with respect to potential further development of AZD3480 in Alzheimer's disease or ADHD is now expected in the first half of 2009, pending completion of the adult ADHD study and other ongoing evaluations.

"While this trial outcome did not meet our objectives, we continue to pursue medicines that target neuronal nicotinic receptors (NNRs) with Targacept to treat cognitive disorders," said Bob Holland, Vice President and Head of the Neuroscience Therapy Area, AstraZeneca.

Targacept and AstraZeneca also announced that the lead compound arising out of the parties' preclinical research collaboration is poised to enter the clinic. AstraZeneca plans by the end of 2008 to initiate a Phase I trial of AZD1446 (TC-6683), a product candidate selective for the alpha4beta2 NNR. Under the terms of the parties' collaboration agreement, AstraZeneca has agreed to make a $2.0 million milestone payment to Targacept.

"We are obviously disappointed that AZD3480 did not meet our goals in the HALO trial," commented J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. "We thank AstraZeneca for its commitment to AZD3480 and its investment in this pioneering work in an emerging area considered to be critical in the treatment of patients with schizophrenia. We look forward to continuing our cognition-focused collaboration with AstraZeneca."

Study Design

The Phase IIb HALO trial was conducted by AstraZeneca under the terms of an exclusive global license and research collaboration agreement. The trial was a multi-center, randomized, double blind, placebo controlled, dose-finding study conducted at approximately 70 enrolling sites in the United States and Canada. Subjects (n = 445) between 18 and 55 years of age who were active smokers and taking medication from the class of drugs known as atypical anti-psychotics were randomly assigned to one of three dose groups of AZD3480 or to placebo and dosed over a 12-week period. The primary outcome measures of the trial were change from baseline after 12 weeks on various domains of cognition as measured by the IntegNeuro computerized test battery(1).

About Cognitive Dysfunction in Schizophrenia

Schizophrenia is a chronic, severe and disabling form of psychosis that, in addition to symptoms such as delusions and hallucinations, is often marked by impairments in cognitive functions such as attention, vigilance, memory and reasoning. These cognitive impairments play a primary role in the inability of schizophrenic patients to function normally. It has been estimated that there are 7.9 million schizophrenic patients in the world's seven major pharmaceutical markets and that the majority of all schizophrenic patients are cognitively impaired.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca-us.com.

About Targacept

Targacept is a clinical-stage biopharmaceutical company that discovers and develops NNR Therapeutics (TM), a new class of drugs for the treatment of central nervous system diseases and disorders. Targacept's product candidates selectively modulate neuronal nicotinic receptors that serve as key regulators of the nervous system to promote therapeutic effects and limit adverse side effects. Targacept has product candidates in development for Alzheimer's disease, cognitive dysfunction in schizophrenia, pain and depression, as well as multiple preclinical programs. Targacept also has a cognition-focused collaboration with AstraZeneca and a strategic alliance with GlaxoSmithKline. Targacept's news releases are available on its website at www.targacept.com.

(1) IntegNeuro is a computerized test battery that assesses multiple domains of cognitive function. Five of the domains, Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Reasoning and Problem Solving, were considered primary endpoints in the HALO trial.


'/>"/>
SOURCE AstraZeneca
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA
2. AstraZeneca and Targacept Announce Top-Line Results from Phase IIb Study of AZD3480 in Alzheimers Disease
3. AstraZeneca Announces Innovative New Partnership With Singapore Institutions to Develop Anti-Cancer Compounds
4. AstraZeneca Submits an sNDA for SYMBICORT(R) for the Treatment of Asthma in Children as Young as Age Six
5. Phase III Study of Abbotts Investigational TriLipix(TM) in Combination With AstraZenecas CRESTOR(R) Meets Primary Endpoints on Key Lipids
6. AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
7. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
8. AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines
9. Volcano Announces Participation in SATURN Clinical Trial Sponsored by AstraZeneca
10. AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
11. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... -- VMS Rehab Systems, Inc. ( www.vmsrehabsystemsinc.com ) reported today ... to build a strong and stable market for trading ... the OTC Markets-pink current trading platform. Explains ... seeing an anomaly in market trading activities that may ... Company, but shareholders and market players as well. I ...
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to a ... new, often overlooked aspect of head lice: the parasite’s ability to live away from a ... occurrence, but a necessary one in the event that lice have simply gotten out of ...
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
(Date:6/24/2016)... ... 2016 , ... Those who have experienced traumatic events may suffer from a ... such as drug or alcohol abuse, as a coping mechanism. To avoid this pain ... following a traumatic event. , Trauma sufferers tend to feel a range of emotions, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... ... , ... People across the U.S. are sharpening their pencils and honing their ... in which patients and their families pay tribute to a genetic counselor by nominating ... of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, ...
Breaking Medicine News(10 mins):