Miraculins Announces Positive Final Results in Pivotal Prostate Cancer Biomarker Study
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- Published on Tuesday, 29 May 2007 04:00
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WINNIPEG, Canada | May 28, 2007 | Miraculins Inc. (TSX VENTURE: MOM), a biotechnology company dedicated to the discovery and validation of cancer biomarkers for use in developing diagnostic tools and therapeutic products is pleased to announce the final results from its PCSC04 study.
PCSC04 was a prospective study of 200 pre-prostate biopsy patients initiated in November 2006 with CMX Research Inc. The study was designed to determine if the Miraculins prostate cancer biomarker diagnostic would be able to reduce the number of negative biopsies for patients that had already been screened by the prostate specific antigen (PSA) test and had been referred to a urologist for additional assessment.
The Company has now completed its analysis of the samples from all 200 patients that were enrolled in the study. The data analyzed has shown that the Miraculins urine based test performed with a specificity that would have eliminated approximately 23% of the biopsies for patients who did not have prostate cancer. The test performed with a sensitivity that correctly identified 93% of patients who were true positives for prostate cancer and needed to be scheduled for a biopsy.
These results were consistent with the positive preliminary results announced by Miraculins on March 19, 2007. Both the test's sensitivity and specificity are expected to improve when an ELISA based test format is fully developed. The study included 3 different urine collection methods including prior to digital rectal examination (DRE), post-DRE and 24 hour collection. The pre-DRE samples performed at the highest level in the study, suggesting that the Miraculins test will be able to rely on a simple collection method.
"This is extremely good news for Miraculins", stated Christopher J. Moreau president and CEO of Miraculins. "The major market focus for our test will be the millions of men who are referred to a urologist annually because they have an elevated PSA level. The Miraculins test will provide urologists with an efficient, non-invasive tool to help them make the correct decision regarding a biopsy for their patients."
"We are estimating the worldwide market for our diagnostic test to be somewhere between $300 to $500 million in sales per year", added Moreau.
"I'm excited for the patients", commented Dr. Richard Casey, president and medical director of CMX Research Inc., and a practicing urologist. "A needle biopsy into the prostate gland is not a pleasant experience for anyone."
Prostate cancer is the most common cancer in Canadian men, affecting one in seven, and the most common non-skin cancer in the United States, affecting one in six men. It is often slow-growing and can be managed successfully if detected early through diagnostic screening.
"Miraculins' test is positioned to make a significant impact on many different fronts, so it looks very promising. When the test becomes available I can definitely see the potential for quick clinical acceptance and widespread use," stated Dr. Casey.
"We have already begun the process of communicating with potential commercialization partners to work with us to take the test through the regulatory approval process and ultimately offer it to the market. These strong final results will only add momentum to our efforts." concluded Moreau.
About The PCSC04 Study
The objective of this prospective study was to assess the utility of biomarkers previously discovered and validated by Miraculins as diagnostic for prostate cancer. This was achieved by conducting a proteomic survey of patients scheduled to undergo prostate biopsies based on previous assessments by a urologist using current best clinical practices, including PSA testing. This study did not involve the use of investigational drugs, manipulations, interventions or the use of placebos. The study involved the collection of urine and serum, a detailed review of medical history and standard medical testing. Patients were required to collect urine for a full 24 period prior to medical examination, at a single time point prior to DRE and at a single time point immediately following DRE. Patient diagnosis was provided after biopsy results were known in order to assess the true rate of diagnostic success of the Miraculins biomarkers being tested in this population.
About CMX Research Inc.
CMX Research Inc. is a Site Management Organization (SMO) conducting pharmaceutical, biotech and medical device research at 32 locations across Canada. CMX's services cover a broad range of study conduct activities that meet FDA, TPD and ICH standards. Research efforts are segmented into clinical specialties with a commitment to ethically, effectively and efficiently conduct medical research.
About Dr. Richard Casey
Dr. Richard Casey, M.D., F.R.C.S. © is the president and medical director of CMX Research Inc. and Fe/Male Health Centers, a treatment network offering comprehensive services in sexual medicine and prostate disorders for men.
Dr. Casey attended the University of Western Ontario Medical School and obtained his surgical training at the University of Toronto. After completing a two year postdoctoral fellowship in Endocrinology, he returned to private practice in Ontario.
In 1992, Dr. Casey determined that clinical research could be organized in a network of sites in order to provide standardized processes and procedures to benefit client companies' desires for accelerated clinical development. He formed CMX Research Inc. to acknowledge and meet this need across a range of therapeutic specialties.
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 B.E.S.T. 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. SOURCE: Miraculins Inc.