Pipex Initiates Phase II Alzheimer's Trial
Posted on: Tuesday, 8 January 2008, 09:00 CST
Pipex Pharmaceuticals has initiated a 150-patient, double-blind, placebo-controlled Phase II clinical trial of its lead anti-copper drug candidate, Coprexa for the treatment of Alzheimer's disease.
The double blind, placebo-controlled, Phase II clinical trial is intended to enroll 150 mild to moderate AD patients who have an elevated levels of 'free' copper. Patients will be randomized on a 1:1 basis to receive either Coprexa plus an acetylcholineserase inhibitor or a placebo plus an acetylcholineserase inhibitor during the course of the study.
The primary endpoint of the study is to evaluate cognition at 24 and 52 weeks utilizing the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog). Secondary endpoints will evaluate changes in hippocampal volume measured by Magnetic Resonance Imaging (MRI) as well as other advanced neuroimaging markers of AD progression. The clinical trial is being conducted at four clinical trial sites throughout Italy.
The Phase II clinical trial is being partially supported by a grant from Italian Ministry of Health which is expected to fund approximately 30% of the cost of the trial. Coprexa is an oral, small-molecule, anti-copper agent that is highly specific for the reduction of 'free' copper in serum, the most toxic form of copper in the body, and is said to be ideally suited for the treatment of central nervous system (CNS) diseases in which abnormal serum and CNS copper homeostasis are implicated.
Source: Datamonitor
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