Amorfix announces first quarter 2010 results



    TSX: AMF

    TORONTO, Aug. 14 /CNW/ - Amorfix Life Sciences, a company focused on
misfolded protein diseases, today reported its first quarter operating results
and provided an update on the Company's diagnostic and therapeutic programs.
    Recent scientific publications in the field of neurodegenerative
diseases, such as Alzheimer's Disease (AD) and Parkinson's disease, have shown
that misfolded proteins can move from cell to cell in the nervous system. This
opens the possibility that protein misfolding diseases can be treated, and
perhaps cured, by blocking the "propagation" of protein misfolding in the
space between cells. Amorfix initially developed its immunotherapeutic
approach to amyotrophic lateral sclerosis (ALS) based on the idea that
misfolded SOD1 propagates between cells, and can be neutralized by antibodies
and thereby stop disease progression. The Company was the first to show
antibodies and vaccines to Disease Specific Epitopes (DSE) on misfolded SOD1
could significantly prolong the life of ALS model mice. Building on its
growing expertise in this field, the Company has recently expanded its focus
to include misfolded proteins in cancer, using its proprietary ProMIS(TM)
platform to predict protein misfolding and identify novel DSEs to develop
targeted therapeutics and companion diagnostics.

    Development and Corporate Highlights

    
    vCJD
    ----
    -   On July 17, 2009 the UK framework tender award for the supply of
        systems to screen plasma samples from blood donations for vCJD was
        published on the European Tenders Electronic Daily website indicating
        that Amorfix and one competitor were successful.

    -   In June 2009, the Company announced that it had tested 20,000 blood
        donations in France. Based on the UK requirement of a sensitivity of
        1:100,000 dilution of vCJD brain, the Amorfix test was 100% specific
        with no false positive samples on repeat testing. The test performed
        five times better than required as it was still 100% specific at a
        demonstrated sensitivity of 1:500,000 dilution of vCJD brain. At the
        maximum sensitivity of 1:1,000,000 dilution of vCJD brain, the test
        was 99.90% specific which exceeds the 99.85% specificity required by
        the UK Blood Transfusion Service. The complete Strasbourg study was
        presented in July at le Congrès 2009 de la Société Française de
        Transfusion Sanguine.

    -   In May 2009, the Company announced the process to define a CE mark
        for a blood screening test for vCJD reached a major milestone. The
        European Union's vCJD Experts Working Group met April 29, 2009 and
        completed the draft Common Technical Specifications (CTS) and
        guideline. These draft documents outline the requirements for CE
        marking of IVDs for vCJD, are now ready for adoption by the IVD
        Technical Group at their September meeting.

    -   In April 2009, the Company announced that it was advised that it is
        required to test additional prion-infected animal samples, supplied
        by the UK National Institute for Biological Standards and Control
        (NIBSC), prior to being granted access to the human vCJD blood
        samples.

    ALS/ AD
    -------
    -   Preclinical active and passive immunotherapy studies targeting
        misfolded SOD1 in AD continue on schedule with results expected first
        quarter calendar 2010.

    -   We continue to seek partners for our antibodies and vaccines to
        misfolded SOD1 in ALS having achieved all of our preclinical
        milestones for this indication by identifying and developing
        monoclonal antibodies to the Disease Specific Epitopes on misfolded
        SOD1 and by demonstrating increased survival in ALS mouse studies.

    -   In April 2009, Amorfix announced that the Amorfix Aggregated Abeta
        Assay (A(4)) has been shown to detect Abeta amyloid in human and
        animal brain tissue. Since the A(4) test is able to detect amyloid
        build up in animals much earlier than conventional methods, the
        company believes the test will accelerate the development and
        evaluation of new treatments for AD.

    -   On July 25, 2009, the Company presented validation results for the
        A(4) assay at the International Congress on AD. The Company is
        seeking collaborations and offering the A(4) test as a service to
        drug discovery companies and academic researchers working to discover
        new treatments for AD.

    Other Misfolded Protein Diseases
    --------------------------------
    -   In April 2009, Amorfix announced the extension of its therapeutics
        program to target proteins which may be misfolded in diseases where
        cells are under stress, such as many cancers. In June 2009, the
        Company licensed the exclusive rights to the ProMIS(TM) target
        identification technology from the University of British Columbia
        (UBC), to predict novel Disease Specific Epitopes (DSE) on the
        molecular surface of misfolded proteins. Amorfix is exploring
        partnerships to accelerate the development and expand this new
        program.
    

    "Amorfix achieved a significant milestone on the award of the UK tender
after many years of effort. We are focused on continuing the validation and
regulatory process for the vCJD assay to achieve market acceptance," said
George Adams, President & Chief Executive Officer of Amorfix. "Our new
ProMIS(TM) technology has great potential and provides a novel and efficient
way to extend our research and development program with misfolded proteins,
and our A(4) assay continues to generate interest from Alzheimer's
researchers."

    Financial Results

    For the three months ended June 30, 2009, the company reported a net loss
from operations of $1,170,741 ($0.03 per share) compared to net loss of
$1,606,184 ($0.04 per share) for the three months ended June 30, 2008.
    Research and development (R&D) expenses for the three months ended June
30, 2009 were $880,188 compared with $1,367,167 for the three months ended
June 30, 2008. The decrease was due mainly to staffing reductions made in June
2008 related to the deferral of commercialization work for vCJD until the UK
NIBSC process is completed, staffing reductions in the ALS therapeutics
program made in December 2008, and other cash conservation initiatives.
    General and administrative expenses for the three months ended June 30,
2009 were $290,808 compared with $263,264 for the corresponding period in
2008. The increase for the three months ended June 30, 2009 resulted mainly
from higher stock-based compensation and investor relations expenses than in
the comparable period.
    At June 30, 2009, the company had working capital of $6,622,115 and
47,687,481 common shares outstanding.
    On April 29, 2009 the company completed a private placement financing of
units consisting of one common share and one-half common share purchase
warrant for gross proceeds to Amorfix of $3.3 million.

    Outlook

    The company's fiscal 2010 diagnostic priorities are to:

    
    -   complete the NIBSC process to validate the performance of the
        EP-vCJD (TM) Blood Screening Assay using human vCJD patient samples
        and to manufacture and supply diagnostic kits for assessment and
        prevalence studies;

    -   continue to generate assay performance data in France for the vCJD
        assay in a blood transfusion center;

    -   form collaborations to further validate the benefits of the A(4)
        amyloid assay and to launch a service business providing this assay
        for testing preclinical samples; and

    -   complete development of a screening test for liver cancer in
        collaboration with BioMosaics and Sunnybrook Research Institute.

    The company's 2010 therapeutic priorities are to:

    -   engage new partners for the ALS vaccine and antibody DSE programs;

    -   complete proof-of-concept preclinical studies for Alzheimer's Disease
        targeting misfolded SOD1;

    -   leverage the company's core capability of identifying misfolded
        protein targets and to seek development partnerships for new
        therapeutic targets.
    

    Additional information about the Company, including the MD&A and
financial results may be found on SEDAR at www.sedar.com.

    About Amorfix

    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 more recent evidence points to misfolded proteins
being created in many cancers. 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
ALS.

    The TSX 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. 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 otherwise.

    %SEDAR: 00022789E




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,
george.adams@amorfix.com; James Parsons, Chief Financial Officer, Amorfix Life
Sciences Ltd., Tel: (416) 847-6929, Fax: (416) 847-6899,
james.parsons@amorfix.com

Organization Profile

Amorfix Life Sciences Ltd.

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