PEB - PRELIMINARY FULL YEAR DISCLOSURE
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Pacific Edge Biotechnology Limited (PEB) | 2:10 pm, Friday 30 May 2008 | PEB | 0.100 |
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PRELIMINARY FULL YEAR DISCLOSURE
Pacific Edge Biotechnology
Year End 31 March 2008
The Company has launched its bladder diagnostic clinical trial in hospitals
and private practices in New Zealand. This has been a significant achievement
for the Company with its maiden product in bladder cancer. The clinical trial
for the detection of bladder cancer, using urine samples, will be carried out
on nine sites in New Zealand. The clinical trial follows a period of
extensive validation of the candidate biomarkers that form the test that is
designed to test the robustness of the assay by examining urine samples
collected from patients with a variety of complicating circumstances. The
clinical trial is seen as the last step on the path to commercialisation.
Recruitment of the patients into the trial will occur over the following 12
months and the Company could reasonably expect to complete the trial analysis
by the first half of 2009. A successful outcome of the clinical trial is
expected to provide the Company with a commercial ready product for markets
outside the United States. Negotiations are underway with diagnostic
companies in the US and Europe. These companies have diagnostic delivery
platforms ideally suited to PEB's bladder test.
The customers for this bladder cancer test are urologists, specialist
clinicians that focus on urological disorders and diseases. Of the 300
urologists in Australasia the Company has identified a number of leading
urologists who are working with the test in the clinical trial phase and are
expected to become early customers.
Development work on the Company's other cancer diagnostic and prognostic
products continues with significant success in the melanoma prognostic
product and more recently, the gastric cancer diagnostic product. After a
long and technically challenging period of discovery, a prototype of five
biomarkers has been identified for detection of gastric cancer. This will be
a test based on a blood sample and as such is significantly different from
the Company's bladder test. This short list of protein biomarkers for gastric
cancer has been shown to be present in elevated amounts in serum (blood)
samples taken from gastric cancer patients. A further patent has been derived
from this work and is in process of being submitted to the US Patents Office.
Next steps involve further validation science followed by a clinical trial.
Gastric cancer is a significant issue in Japan and other parts of Asia with
both Korea and Japan having free national screening programs for people over
40 years of age. Pacific Edge Biotechnology has been working with several
companies in Japan that have a strong interest in commercialising a new and
effective early diagnostic tool for gastric cancer.
The Company has recorded a net loss of $1,917,775 for the year ended 31 March
2008, compared to a budgeted loss of $2,300,616 for the year and a
corresponding loss of $1,880,836 for the year ended 31 March 2007. The
company continues to focus on products nearest to market and as such the
bladder cancer assay is the company's lead product. As a matter of policy,
the Company continues to write off all research and development expenditure
until the point at which products or projects provides reasonable certainty
of cost recovery. The Company, over this period has made further significant
investment in intellectual property protection, product development and in
the clinical trial for the Company's cancer detection assay
Between May 2007 and December 2007 the Company raised $5.2 million dollars
via a Special Share Purchase Plan (SPP), to existing shareholders and the
issue of new shares to habitual investors. The limited issue to habitual
investors offered shares at 13.7 cents and Special Share Purchase Plan (SPP)
shares were offered to existing shareholders at 12.9 cents. The Company looks
forward to an exciting year as it moves closer to commercialisation.
For further information please contact;
David Darling or Chris Swann
Chief Executive Officer Chairman
P: 03 479 5800 P: 03 479 0190
C: 021 797 981 C: 027 433 0191
