Amorfix Life Sciences (TSX:AMF), a company focused on treatments and diagnostics for misfolded protein diseases, provides an update on the development of a blood test for vCJD, one of its six product development programs.
The company has been successful in developing versions 2 and 3 of the test, which differ in the sample preparation steps, and both are four times more sensitive than the first version which underwent testing with vCJD patient blood in December. The company has also been successful in obtaining a rare blood sample from a person in the clinical phase of vCJD. The new versions of the EP-vCJD tests were used to test this sample and it was scored negative by both versions of the test.
"Although we were able to achieve unprecedented sensitivity with brain prions diluted into blood, we have been unable to detect blood prions with the latest versions of the test," said Dr. Neil Cashman, CSO of Amorfix. "At this stage, we believe our other product development programs are a better use of our resources, although future research may prompt reevaluation of this assessment."
The Amorfix test and those of its competitors were developed using blood samples spiked with brain prions from vCJD patients. Amorfix successfully developed the most sensitive and specific test in the world and was the first to access human samples through the UK National Institute of Biological Standards and Control process. Subsequent significant improvements to the test in the last five months did not yield positive results, and the company has reached an impasse until scientific understanding improves or more vCJD patient blood is available. Accordingly the company will suspend the commercialization of the vCJD project allowing a more focussed effort on the development of novel therapeutics and diagnostics which include:
- Our ProMIS(TM) antibody program targeting disease specific epitopes for both therapeutics and companion diagnostics for cancer and other misfolded protein diseases; - Growing the revenue from our A(4) amyloid testing service for cell culture, tissue and blood in animal models of Alzheimer's disease (AD); - Development of a human Alzheimer's test adapting the A(4) test protocol to detect aggregated Abeta, the hallmark of the disease, in human plasma and cerebro-spinal fluid; - The advancement of our novel antibodies and vaccines for the treatment of ALS and AD; and - The contract for the development of a liver cancer early detection assay, which is nearing completion.
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