Miraculins Inc.

Miraculins Inc.

October 16, 2008 09:43 ET

Miraculins Announces Enrollment of First Patient in Second Pivotal Prostate Cancer Study

WINNIPEG, MANITOBA--(Marketwire - Oct. 16, 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 the enrollment of its first patient in the second pivotal study for the Company's P2V™ prostate cancer diagnostic test. The study will be conducted at the Winnipeg Clinic under the guidance of Principal Investigator, urologist, Dr. Patrick Cho. Samples collected from the study will be tested using recently developed Luminex based assays for both PSP94 and Vitronectin, the two proteins that form the P2V™ test.

"Our goal with this study is to clearly show that the P2V™ test will safely reduce the number of men who are currently being selected to undergo a prostate biopsy based on their PSA score alone, only to find out afterwards that they are negative for prostate cancer." stated Mr. Christopher J. Moreau, president and CEO of Miraculins Inc. "Biopsies are usually not a one time event for an individual, with many men undergoing multiple biopsies over the course of their lives. They are unpleasant, uncomfortable, can often result in complications and are costly to the healthcare system. We are determined to reduce the suffering of these men, and to make a significant impact on reducing costs for the health care system by working hard to make the P2V™ test available as soon as possible"

Based on feedback received from the FDA after the Company filed a PRE-IDE application in the fall of 2007, this 2nd pivotal study is designed to focus on men who have a PSA score of between 2.5 ng/mL and 10 ng/mL with a normal DRE (digital rectal exam) result. Urine samples will be collected from patients prior to biopsy and will be analyzed by the Company using the P2V™ test which has been internally developed on the Luminex platform. Pathology reports will be obtained from the patient's biopsies, enabling the Company to categorize participants as having prostate cancer or other non-cancerous conditions. This is the first time that the Company will assay samples using a clinical grade assay platform.

The PSA test is the current screening standard for prostate cancer. There are greater than 25 million PSA tests performed annually in the United States alone, resulting in one million prostate biopsy procedures annually. 75% of these biopsies produce negative test results resulting in an estimated $1.5 Billion cost to the US healthcare system.

"Each prostate biopsy has significant costs associated with it," added Dr. Stephen Frost, Director of Research and Development at Miraculins. "For patients, there is a physical and psychological cost, for the insurance and healthcare systems, there is a considerable monetary cost. We are rapidly developing our research use only test and I am very optimistic that upon completion of this study, we can begin to aggressively pursue regulatory approval and a commercialization strategy that will bring the P2V™ test to market."

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.

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 research 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.

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