Miraculins Inc.

Miraculins Inc.

November 29, 2007 09:05 ET

Miraculins Files Pre-Investigational Device Exemption With FDA for P2V™ Prostate Cancer Test

WINNIPEG, MANITOBA--(Marketwire - Nov. 29, 2007) - Miraculins Inc. (TSX VENTURE:MOM), a biotechnology company, dedicated to the discovery and development of diagnostic tools and therapeutic products for cancer, is pleased to announce that it is filing today, a pre-IDE (Investigational Device Exemption) submission with the U.S. Food and Drug Administration (FDA), in preparation for its planned clinical study for its P2V™ prostate cancer diagnostic test.

The pre-IDE application is a process made available by the FDA to provide early feedback to medical device and diagnostic companies that are planning their clinical study path for regulatory approval. The process includes filing an investigational plan overview and includes a meeting with FDA officials, allowing the company to gain direct insight on various issues, such as the appropriate number of patients that will be required for the clinical study.

"We are confident in the results of our research that demonstrates the potential of P2V™ to eliminate 1 out of every 4 unnecessary biopsies worldwide, which is a potential $500 million market," stated Christopher J. Moreau president and CEO of Miraculins. "We have already received initial feedback from the FDA regarding classification of our diagnostic test and the filing of this pre-IDE application brings us one step closer to the market."

In addition to seeking guidance on the P2V™ diagnostic test, the pre-IDE application will also include an investigational plan overview for the tumor grading potential of the test. In addition to its diagnostic potential, the test's protein biomarkers were able to distinguish aggressive prostate cancer (cancers with a Gleason grade of 7 or higher) from non-aggressive prostate cancer with a sensitivity and specificity of 92% and 55% respectively. Once the FDA provides its response to the pre-IDE application, the Company will formalize plans for its clinical study.

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 Prostate Cancer

Prostate cancer is responsible for greater than 240,000 new cancer diagnoses in North America each year. The current screening standard for prostate cancer, the PSA test, is ineffective at reliably distinguishing between non-life threatening prostate conditions and critical prostate cancer. There are greater than 25 million PSA tests performed annually in the United States alone, resulting in one million prostate biopsy procedures. 75% of these biopsies produce negative test results and would therefore be avoidable if an improved diagnostic technique were available.

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™ 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.

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

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