WINNIPEG, Manitoba – January 22, 2009 – Miraculins Inc. (TSX-V:MOM), a medical diagnostic company focused on developing and commercializing diagnostic tests for unmet clinical needs, announces today the successful completion of testing to characterize the performance of its P2V™ test in an immunoassay format. The results confirmed the test’s diagnostic performance as a biopsy screening tool providing a 91% sensitivity with a 25% specificity. These results are statistically similar in performance to the mass spectrometry assay results which earlier reported the test performing with a 93% sensitivity and a 23% specificity. The P2V™ test is a patent pending combination of two markers, PSP94 and a fragment of vitronectin, for use as a biopsy screen tool for patients with prostate cancer.
“We were very pleased by the performance of the immunoassay, which was developed quickly and efficiently by our team under the direction of Dr. Stephen Frost, and we continue to be impressed by the performance of the markers, which consistently demonstrate the ability to reduce unnecessary biopsies compared to existing techniques”, commented Mr. Christopher J. Moreau, president and CEO of Miraculins.
“The sample set utilized for testing the P2V™ immunoassay was sourced from Miraculins’ internal sample bank and concentrated on 122 men in the critical PSA range of 2.5 ng/ml to 10 ng/ml with a normal digital rectal exam (DRE)”, said Dr. Stephen Frost, director of research and development for Miraculins.
“The samples tested were from both spot collections and 24 hour collections taken during the Company’s last major clinical study. While the 24 hour samples did not show improvement over the spot collection samples in testing for this utility, from a clinical perspective, 24 hour collection may be preferred to reduce variability associated with circadian rhythm. Internal testing by Miraculins confirmed the day to day variation in the PSP94 markers’ expression,“ continued Dr. Frost.
Building on the independent literature for PSP94, the Company also expanded its research on the previously announced second utility for the test as a tool for determining the aggressiveness of a prostate cancer, using the newly developed immunoassay format. P2V’s™ ability to separate aggressive cancers (defined as Gleason score 7 or higher) from healthy, BPH, and non aggressive cancers (Gleason score of 6 or less) with a sensitivity of 90% and a specificity of 51% was confirmed after re-testing 24 hour collection samples from Miraculins’ internal sample bank. Miraculins is continuing to review these results and file additional intellectual property and plans a further update to the market on this utility in the near term.
“We now have a complete package to provide potential partners, which includes solid data from functioning assays”, said Moreau. ”Therefore, Miraculins is now concluding any ongoing research and development on our prostate cancer program and will focus our efforts on finding a suitable development and commercialization partner.”
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 research conducted at leading research institutions around the world and commercially available diagnostic tests.
For more information, please contact:
The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
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.