Attention Business Editors:
Amorfix announces leading sensitivity for prion detection in spiked human blood samples
TSX Venture: AMF
TORONTO, June 21 /CNW/ - Amorfix Life Sciences Ltd. announced today it
had completed the analysis of the international reference blinded panels of
human blood samples spiked with prions from variant Creutzfeldt-Jakob Disease
(vCJD) patients which were provided by the UK government.
"Our excellent results from the blinded panels match our previous
internal tests using spiked blood samples. Based on data presented at industry
conferences on 4 other laboratories and companies that have completed the
blinded panels, we are confident that the company's EP-CJD(TM) assay is
significantly more sensitive in detecting prions," said Dr. George Adams,
Chief Executive Officer, Amorfix.
"Having superior sensitivity should give Amorfix a competitive advantage
in the early detection of prions in blood from donors who are infected but do
not yet show symptoms of the disease," said Dr. Neil Cashman, Chief Scientific
Officer, Amorfix. "We look forward to testing blood samples from people who
have unfortunately been infected with vCJD and preclinical samples from
infected but asymptomatic animals to further validate the utility of the
EP-CJD(TM) to secure the blood transfusion systems worldwide." Dr. Cashman
will be presenting the blinded panel results at the Transmissible Spongiform
Encephalopathies conference in Vienna, Austria, on June 28th.
The National vCJD Surveillance Unit (NCJDSU) and the British National
Institute for Biological Standards and Controls (NIBSC) direct the
international testing program and will publish an independent analysis of all
these benchmarking results from those companies who participated. The NCJDSU
has blood and tissue samples from approximately 150 people who have been
diagnosed with vCJD and subsequently died. The company has sent a request to
the British Department of Health, Tissue Management Group to access the final
blinded panels containing blood samples from patients with variant CJD,
patients with sporadic CJD, patients with other neurological conditions and
"normal controls" from blood donors. These results will be used to apply for
regulatory approval to market the test in Europe. Since no company, academic
or research group has accessed these samples and obtained a CE mark for an
assay for vCJD in blood, it is uncertain how many samples are available for
testing and exactly how long the process will take. The company is proceeding
to mount its assay onto a commercial platform.
Recent evidence has suggested that people may be infected for decades
before showing signs of vCJD. The number of people who contracted the disease
by consuming BSE-positive beef is unknown and three people have been shown to
have been infected through blood transfusion from donors who years later
developed symptoms and died from vCJD. Thousands of people who received
CJD-positive plasma fractions are currently being monitored to determine how
many have been infected. Blood transfusion systems in low-risk countries
refuse to take blood from people who have lived in high-risk countries, where
BSE-positive cattle were prevalent, to prevent the spread of the disease
through blood transfusions. A screening test for vCJD is needed immediately to
secure the blood transfusion systems worldwide.
About Amorfix
Amorfix is an emerging theranostics company focused on the diagnosis and
treatment of neurodegenerative diseases, where aggregated misfolded proteins
(AMPs) are prevalent. These include aggregated misfolded prion protein which
makes up "prions," the infectious agents of the Transmissible Spongiform
Encephalopathies (TSE's), such as Bovine Spongiform Encephalopathy (BSE or
"mad cow disease") and the human form, variant Creutzfeldt-Jakob Disease
(vCJD), as well as degenerative diseases such as Alzheimer's Disease (AD),
Amyotrophic Lateral Sclerosis (ALS) and Parkinson's Disease (PD). Amorfix was
formed to commercialize epitope protection technologies and related
discoveries to become the world leader on AMP diseases. The company will use
this new knowledge to develop diagnostic kits, therapeutics and preventative
therapies for AMP diseases.
The TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of this release. This information
release may contain certain forward-looking information. Actual future results
may differ materially from those contemplated. The risks, uncertainties and
other factors that could influence the actual results are described in
documents filed with regulatory authorities.
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