Miraculins Provides Update on P2V(TM) Assay Development
Miraculins Inc. (TSX VENTURE: MOM), a medical diagnostic company focused on developing and commercializing diagnostic tests for unmet clinical needs, is pleased to update the market on its assay development progress for PSP94 and Vitronectin, the two proteins which comprise the Company’s P2V(TM) prostate cancer test.
Since the Company’s previous update on August 14, 2008, the analytical performance of the PSP94 test has been optimized. The assay is successfully detecting PSP94 from 0.15 ng/mL up to 12 ng/mL. Furthermore, the PSP94 assay is highly reproducible with less than 10% coefficient of variation when run for more than 30 days and handled by multiple technicians. Most importantly, the assay results are not altered by differing urine concentrations as determined by spiking PSP94 into urine and diluting urine into assay buffer.
In addition, the initial results from the recovery studies with the Company’s prototype Vitronectin assay have also been positive. The assay is successfully detecting the somatomedin B epitope of Vitronectin, the epitope identified by Miraculins as diagnostic for prostate cancer in urine samples. The robustness of the assay has been demonstrated through recovery studies with diluted urine samples. Development work is being conducted using the clinically accepted Luminex system, while the Company evaluates a number of research kit and final clinical commercialization platform options.
Enabling the availability of a high quality research use only kit for both Vitronectin and PSP94 is important to the Company’s strategy of encouraging the development of a wider body of scientific study on these important markers.
“The rapid development of these two prototype immunoassays from what originally began as mass spectrometric data clearly demonstrates the scientific capability of Miraculins as a growing assay development company”, stated Dr. Stephen Frost, Director, Research and Development for Miraculins Inc. “Our functional Vitronectin immunoassay is successfully detecting our epitope of interest 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.”
About the P2V(TM) Prostate Cancer Test
The P2V(TM) 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.
The Company recently 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 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(TM), 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.
Contacts: Miraculins Inc. Christopher J. Moreau President and CEO (204) 477-7599 (204) 453-1546 (FAX) Email: info@miraculins.com Website: www.miraculins.com
SOURCE: Miraculins Inc.
