TORONTO, April 20 /CNW/ - Amorfix Life Sciences (TSX:AMF), a company
focused on treatments and diagnostics for misfolded protein diseases wishes to
outline its six (6) product development programs.
"Our vCJD test is being used in feasibility testing by the national blood
transfusion service in France and our antibodies and vaccines for ALS have
shown prolongation of life in preclinical studies," said Dr. George Adams, CEO
of Amorfix. "With this success, it is time to expand our focus and apply our
expertise to more misfolded protein diseases."
Blood test for variant Creutzfeldt-Jakob Disease (vCJD): Based upon its
patent pending Epitope Protection technology, Amorfix has developed the most
sensitive (100% at 1:1,000,000 dilution of brain homogenates spiked into blood
samples) and specific (99.9% based on 10,000 normal samples) test
(EP-vCJD(TM)) for vCJD prions ever reported. This exceptional performance of
the vCJD test has been verified in collaboration with the National Institute
for Biological Standards and Control (NIBSC) in the United Kingdom. Further,
the blood transfusion service in France is conducting large-scale testing of
blood donations to demonstrate the feasibility of routine testing of blood
donations for vCJD in Strasbourg and is enabling a second blood transfusion
centre in Montpellier. The results from the Strasburg study will be presented
at le Congrès 2009 de la Société Française de Transfusion Sanguine in
Strasbourg, June 22-25, 2009.
Amorfix is the leading company in the NIBSC process to further validate
the EP-vCJD(TM) by testing rare blood samples from vCJD patients to
demonstrate the test can detect human blood prions, as well as human brain and
spleen prions. Amorfix has been informed that it will be required to test
additional prion-infected animal samples, supplied by NIBSC, prior to being
granted access to the vCJD blood samples. Amorfix expects to carry out this
additional animal testing in the next few weeks at the NIBSC laboratories.
Testing the human patient samples may also be a requirement prior to
initiating prevalence testing in the UK. On March 18, 2009, the UK National
Health Service published a tender to supply blood test kits for a 10,000
sample assessment panel, a 50,000 sample prevalence study, and unlimited kits
for routine testing.
Tissue test for Abeta amyloid in Alzheimer's disease (A4): The company
received an IRAP grant to develop a test for Alzheimer's disease. To date, the
test has been shown to detect Abeta amyloid in human and animal brain tissue.
The validation results for the A4 test will be presented at the International
Congress on AD this summer and the company will be offering the A4 test as a
service to drug discovery companies and academic researchers working to
discover new treatments for AD. Since the A4 test is able to detect amyloid
build up in animals much earlier than conventional methods, the A4 test will
accelerate the development and evaluation of new treatments for AD.
Blood test for sheep scrapie: The company has developed a prototype blood
test for scrapie in live sheep and shown it can detect infected lambs. An
analysis of the market opportunity suggests scrapie must be recognized as a
public health issue (that is newer strains of scrapie are shown to cause vCJD)
before it would be widely used to eliminate scrapie-infected sheep.
Accordingly, the company has suspended further development until testing of
the newer strains of scrapie has been reported.
New blood tests for misfolded proteins: The excellent results with the
vCJD testing platform have given the company an opportunity to expand its menu
of diagnostic tests. Amorfix has identified companies and academic groups with
established biomarkers that can be developed into screening tests.
Announcements will be made as each project is initiated.
ALS (Lou Gehrig's disease): The company has shown its antibodies and
vaccines to misfolded SOD1 can prolong life in an animal model of ALS. It is
seeking to partner with a biotechnology company to humanize the antibodies and
initiate clinical trials. A special Committee of the Board of Directors has
been formed to oversee the process. Because vaccines have different
development timelines and require special expertise compared to the
antibodies, Amorfix is seeking other partners to develop the vaccines. It is
hoped these partnerships will be established before the end of the calendar
Alzheimer's disease: The company has identified misfolded SOD1 co-located
with the Abeta amyloid in the brains of people with AD. Since misfolded SOD1
is known to be toxic for nerve cells, the company has initiated preclinical
animal studies with its antibodies and vaccines to determine their therapeutic
potential for AD. A CIHR-POP II grant was awarded to conduct these studies
which should have first results by the end of the calendar year.
New misfolded protein therapeutics: The company is the world leader in
demonstrating antibodies and vaccines to misfolded proteins are therapeutic in
neurodegenerative diseases. The process of identifying novel disease-specific
epitopes (DSE) on misfolded proteins is extremely complex and represents a
unique core expertise of the company and its CSO. The company plans to target
proteins which may be misfolded in diseases where cells are under stress and
more likely to produce misfolded proteins like cancer. Once a protein has been
identified, antibodies and vaccines can be developed as previously shown. The
company is establishing strategic alliances to expand its capabilities to
develop immunotherapeutics to numerous proteins. These alliances will be
announced as they are formed.
Amorfix Life Sciences Ltd. (TSX:AMF) is a theranostics company developing
therapeutic products and diagnostic devices targeting misfolded diseases
including neurodegenerative diseases and cancer. It has specific programs in
vCJD, ALS and Alzheimer's Disease. Amorfix's proprietary Epitope
Protection(TM) (EP) technology enables it to specifically identify very low
levels of aggregated misfolded proteins (AMP) in a sample containing normal
protein. Aggregated misfolded proteins are a common element of many brain
wasting diseases and cancer. Amorfix has shown antibodies and vaccines to
misfolded proteins are therapeutic in preclinical animal models. Amorfix's
lead programs are a diagnostic blood screening test for vCJD and a therapy for
This information release may contain certain forward-looking information.
Such information involves known and unknown risks, uncertainties and other
factors that may cause actual results, performance or achievements to be
materially different from those implied by statements herein, and therefore
these statements should not be read as guarantees of future performance or
results. All forward-looking statements are based on the Company's current
beliefs as well as assumptions made by and information currently available to
it as well as other factors. Readers are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date of this
press release. Due to risks and uncertainties, including the risks and
uncertainties identified by the Company in its public securities filings,
actual events may differ materially from current expectations. The Company
disclaims any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or
For further information:
For further information: Dr. George Adams, President & Chief Executive
Officer, Amorfix Life Sciences Ltd., Tel: (416) 847-6959, Fax: (416) 847-6899,
firstname.lastname@example.org; James Parsons, Chief Financial Officer, Amorfix Life
Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899,