Miraculins Inc.

Miraculins Inc.

August 14, 2008 09:03 ET

Miraculins to Sell Research Use Kits to Detect PSP94

Company develops functioning prototype assay for detecting PSP94 in urine

WINNIPEG, MANITOBA--(Marketwire - Aug. 14, 2008) - Miraculins Inc. (TSX VENTURE:MOM), a medical diagnostic company focused on developing and commercializing diagnostic tests for unmet clinical needs, is pleased to announce that the Company has completed development of a prototype assay for PSP94 (Prostate Secretory Protein) on the Luminex Bio-Plex 200 Protein Array System and plans to manufacture and begin selling PSP94 based test kits for research purposes by the end of 2008. As previously disclosed by Miraculins, PSP94 plays a significant role in the Company's P2V™ panel test that is currently being internally developed.

PSP94 is a cancer biomarker that has been recognized in the scientific literature for its ability to a separate benign prostatic hyperplasia (BPH) specimens from prostate cancer specimens in urine (Teni et al Cancer Letters: 43 (1988) p9), a finding that has been confirmed independently by Miraculins through numerous research studies on mass spectrometry. On June 4, 2008 the Company announced its intention to internally develop the immunoassays for PSP94 and the fragment of Vitronectin, comprising its P2V™ panel for the detection of prostate cancer. The functioning prototype assay for PSP94 represents a major step towards the achievement of this goal.

The Company's prototype PSP94 assay is successfully detecting recombinant protein in samples, and has completed a recovery study establishing its ability to detect PSP94 spiked urine samples with the same accuracy as spiked control fluid, thereby clearly establishing that urine does not interfere with the assay. Although development work is being conducted using the clinically accepted Luminex system, the Company is still evaluating a number of options for research kit and the final clinical commercialization platform. The availability of a high quality research use only kit will allow for the development of a wider body of scientific study on PSP94.

"This prototype clearly demonstrates the scientific capability of Miraculins to develop immunoassays in our laboratory", stated Dr. Stephen Frost, Director, Research and Development for Miraculins Inc. "Our functional PSP94 immunoassay detects PSP94 in urine and we are now ready to begin internal manufacturing scale up to create kits for further characterization of assay performance including testing of a number of prostate cancer positive urine samples stored in Miraculins internal sample bank."

"Although research use only kits cannot be used for human diagnostic use, our kit will allow for further study of PSP94 in preclinical and nonclinical settings. Of particular note, manufacturing and selling these kits will further demonstrate our commitment and ability to transition to a later stage development and commercialization Company," stated Christopher J. Moreau, President & CEO of Miraculins Inc. "We have been very pleased with our team's rapid progress on our prototype PSP94 immunoassay and I look forward to providing an update on that development once appropriate."

About the P2V™ Prostate Cancer Test

The P2V™ test is a combination of two biomarkers, PSP94 and a fragment of Vitronectin. The validated performance of the test, through data provided by the Company's pivotal study in May 2007, positions the test as being able to eliminate 23% of unnecessary prostate biopsies, targeting an estimated market size of approximately $500 million.

In May, 2008 the Company announced the initiation of a second pivotal study to focus on a population of 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 2.5 ng/ml and 10 ng/ml with a normal DRE (digital rectal exam) result.

About Miraculins Inc.

Miraculins is a medical diagnostic development company focused on non-invasive tests for unmet clinical needs. Miraculins is bridging the gap between commercially available diagnostic tests and research conducted at leading institutions around the world.

Through an internal biomarker discovery research program, Miraculins has advanced its prostate cancer diagnostic technology through to the development stage. The Company's lead product in development, P2V™, is a simple urine test to be used as a pre-biopsy screen to eliminate a number of men who would otherwise undergo unnecessary prostate biopsy surgery.

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.

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

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