Miraculins to Conduct 2nd Pivotal Study for P2V(TM) Prostate Cancer Test
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WINNIPEG, MANITOBA, May 20 (MARKET WIRE) --
Miraculins Inc. (TSX VENTURE: MOM), a biotechnology company dedicated to
the discovery and development of diagnostic tools and therapeutic
products for cancer, announces today that it will be conducting a 2nd
pivotal pre-biopsy screen study for its urine based P2V(TM) prostate
cancer diagnostic test.
The study will focus on men who have been referred to a urologist and
subsequently have been selected for a prostate biopsy, but will be
restricted to men who have a PSA score of between 2.5ng/ml and 10 ng/ml
with a normal DRE (digital rectal exam) result. The objective of the
study will be to determine the effectiveness of the P2V(TM) test in
reducing the number of unnecessary biopsies in this key group of patients
by being able to screen out the men who have been selected for a prostate
biopsy based strictly on their elevated PSA score, but who do not have
prostate cancer.
"Our first pivotal study was very broad, in that we enrolled all men that
were selected for a biopsy including those with extremely high PSA levels
over 10ng/ml and those that had an irregular DRE result," stated
Christopher Moreau, president and CEO of Miraculins. "This 2nd pivotal
study is in part a result of the feedback that the Company received from
the FDA on its pre-IDE submission, which was especially helpful in
focusing our attention on the most serious deficiency in correctly
diagnosing men who are suspected of having prostate cancer."
Based on this feedback, and under the direction of newly appointed
director of Research and Development, Dr. Stephen Frost, Miraculins
reviewed the data from its last major study to see how the test performed
in this group of patients.
"While the results of our re-analysis were encouraging, by eliminating
the men who were over 10ng/ml and/or had an irregular DRE we ended up
with a vastly reduced data set, resulting in our decision to conduct this
additional study", added Mr. Moreau.
In addition, the company plans on testing the samples from this 2nd
pivotal study using immunoassays for both PSP94 and Vitronectin, the
proteins that form the P2V(TM) panel assay. Miraculins has already
initiated development of these assays.
"Moving to detection using a clinically accepted detection platform is
key to gaining credibility for the P2V(TM) test and to moving quickly to
a commercially viable product", said Dr. Frost.
The Company has completed the study protocol and is expected to begin the
study in approximately 30 days. The projected timeframe for completion is
six months from the beginning of the study.
"The P2V(TM) test will need to perform significantly better than the
current standard of care and any currently marketed tests that target
this specific patient population", said Dr. Frost. "We are looking
forward to having this question answered before the end of 2008."
On November 29th, 2007 Miraculins made a pre-IDE submission to the US
Food and Drug Administration (FDA). A submission made under the pre-IDE
process is not an official IDE application as described in 21 CFR Part
812. The pre-IDE process is designed to help companies obtain early,
informal input on aspects of a future IDE application and offers
assistance in establishing the parameters for official IDE applications
when unique diagnostic tests involving innovative technologies are being
pursued.
About Miraculins Inc.
Miraculins is discovering, validating and developing biological markers
(biomarkers) with clinical relevance for the diagnosis and treatment of
cancers with critical unmet needs. The importance of tumor biomarkers for
"common" cancers has been widely recognized and acknowledged by cancer
experts and leading groups such as the National Cancer Institute and the
American Cancer Society. The Company's BEST(TM) Platform utilizes the
concurrent analysis of clinical factors and biological data, and a
combination of proteomic, mass spectrometric, and protein chemistry
techniques for biomarker discovery.
Caution Regarding Forward-Looking Information
Certain statements contained in this press release constitute
forward-looking information within the meaning of applicable Canadian
provincial securities legislation (collectively, "forward-looking
statements"). These forward-looking statements relate to, among other
things, our objectives, goals, targets, strategies, intentions, plans,
beliefs, estimates and outlook, including, without limitation, our
anticipated future operating results, and can, in some cases, be
identified by the use of words such as "believe," "anticipate," "expect,"
"intend," "plan," "will," "may" and other similar expressions. In
addition, any statements that refer to expectations, projections or other
characterizations of future events or circumstances are forward-looking
statements.
These statements reflect management's current beliefs and are based on
information currently available to management. Certain material factors
or assumptions are applied in making forward-looking statements, and
actual results may differ materially from those expressed or implied in
such statements. Important factors that could cause actual results to
differ materially from these expectations include, among other things:
Miraculins' early stage of development, lack of product revenues and
history of operating losses, uncertainties related to clinical trials and
product development, rapid technological change, uncertainties related to
forecasts, competition, potential product liability, additional financing
requirements and access to capital, unproven markets, supply of raw
materials, income tax matters, management of growth, partnerships for
development and commercialization of technology, effects of insurers'
willingness to pay for products, system failures, dependence on key
personnel, foreign currency risk, risks related to regulatory matters and
risks related to intellectual property and other risks detailed from time
to time in Miraculins' filings with Canadian securities regulatory
authorities, as well as Miraculins' ability to anticipate and manage the
risks associated with the foregoing. Additional information about these
factors and about the material factors or assumptions underlying such
forward-looking statements may be found in the body of this news release.
Miraculins cautions that the foregoing list of important factors that may
affect future results is not exhaustive. When relying on Miraculins'
forward-looking statements to make decisions with respect to Miraculins
investors and others should carefully consider the foregoing factors and
other uncertainties and potential events.
These risks and uncertainties should be considered carefully and
prospective investors should not place undue reliance on the
forward-looking statements. Although the forward-looking statements
contained in this press release are based upon what management believes
to be reasonable assumptions, Miraculins cannot provide assurance that
actual results will be consistent with these forward-looking statements.
Miraculins undertakes no obligation to update or revise any
forward-looking statement.
TSX Venture Exchange does not accept responsibility for
the adequacy or accuracy of this release.
Contacts:
Miraculins Inc.
Christopher J. Moreau
President and CEO
(204) 477-7599
(204) 453-1546 (FAX)
Email: info@miraculins.com
Website: www.miraculins.com
Copyright 2008, Market Wire, All rights reserved.
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