Miraculins Announces Plans To Advance Gastric Cancer Program

Main Category: Cancer / Oncology
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 19 Sep 2008 - 2:00 PST

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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 it has completed the internal review of its gastric cancer program and has confirmed seven blood based protein biomarkers of interest for their potential to separate gastric cancer patients from non-gastric cancer patients. This includes a single marker that performs with a 72% sensitivity at 95% specificity (AUC equals 0.925) known as MIR-GP1. Based on this promising result, the Company plans to advance this program by identifying these markers through protein purification and amino acid sequencing, beginning with MIR-GP1.

The internal review process focused primarily on two original mass spectrometry data sets. The first data set was from a study using 171 samples (92 gastric cancer from stage 1 to stage 4, 79 non-gastric cancer) collected at European sites. The second data set was from a study using 93 samples (72 gastric cancer from stage 1 to stage 4, 21 non-gastric cancer) collected from a number of North American sites. Data analysis was conducted using a variety of statistical techniques including the receiver operator characteristic (ROC) curve. A perfect result with a ROC curve is an area under the curve (AUC) of 1.0 (therefore a sensitivity and specificity of 100% respectively).

In the first data set, two markers had individual sensitivity greater than 70% (72% and 70% respectively) at 95% specificity (AUC equals 0.925,0.89). A further two markers had AUC results of greater than 0.9 (AUC equals 0.922, 64% sensitivity at 95% specificity and AUC equals 0.903, 67% sensitivity at 95% specificity). In all, seven different biomarkers demonstrated an individual sensitivity of over 50% at 95% specificity (AUC greater than 0.76). In the second data set, these same seven biomarkers confirmed their correlation with gastric cancer and had independent AUCs between 0.64 and 0.80. Further displaying the robustness of the data and the promise for future development as immunoassays, one of the biomarkers demonstrated greater than 43% sensitivity at 100% specificity across both data sets using the same cut-off value.

"This is exceptional data for biomarkers analyzed by mass spectrometry", said Dr. Stephen Frost, Director of Research and Development at Miraculins. "The performance of these biomarkers in two data sets, from two separate continents, demonstrates their ruggedness and these top performing gastric biomarkers will make excellent targets for further development. We now look forward to identifying these biomarkers using classical protein purification techniques so that we will be able to more fully evaluate the potential for one or more of these markers to be developed into a commercially viable clinical assay."

"Although our new strategic direction has eliminated our dependence on mass spectrometry based discovery research, we remain committed to maximizing the value of the intellectual property from our existing programs through this internal review process", said Christopher J. Moreau, President and CEO of Miraculins. "The excellent results from Dr. Frost's review of the gastric cancer program means we will be continuing to move this program forward, with the potential of developing the world's first highly sensitive blood based test for early stage gastric cancer."

About Gastric Cancer

The initial diagnosis of gastric cancer is often delayed because up to 80% of patients do not show symptoms during early stages of the disease. Stomach tumors can grow for a long time without causing any signs or symptoms. When symptoms do present, they are often vague and easily mistaken for more common illnesses. Most cases of gastric cancer are discovered only after the disease has advanced, as evidenced by the fact that only 10% - 20% of stomach cancers are found in the early stages before they have spread to other areas of the body.

Endoscopy is the main procedure currently used to diagnose gastric cancer in patients that have certain risk factors, or when symptoms of the disease are present. The diagnosis of gastric cancer could be dramatically improved with the availability of a reliable biomarker test.

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, P2VTM, 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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Miraculins Inc.