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Miraculins announces positive results in pivotal prostate cancer biomarker study |
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20 Mar 2007 |
Diagnostic test positioned to eliminate up to 20% of unnecessary prostate biopsies
WINNIPEG, Canada | Mar 19, 2007 | Miraculins Inc. (TSX:V: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 positive results from its ongoing PCSC04 study.
PCSC04 is a prospective study of 200 pre-prostate biopsy patients initiated in November 2006 with CMX Research Inc. The study was designed to test whether Miraculins’ biomarker diagnostic would be able to reduce the number of unnecessary biopsies when used sequentially with the prostate specific antigen (PSA) test and best clinical care practices.
The Company has completed examination of 130 of the 200 patients enrolled in the study. The data analyzed has shown that approximately 20% of the biopsies for the patients who did not have prostate cancer could have been avoided with the use of Miraculins’ test. In addition, the diagnostic identified 96% of the patients who were true positives for prostate cancer and were required to proceed with a biopsy for further diagnosis.
The PSA test is the current screening standard for prostate cancer. Approximately 70% of PSA tests performed in the U.S. result in false positive diagnoses, requiring these patients to undergo unnecessary prostate biopsies. Many of these biopsies could be avoided with a more accurate diagnostic tool.
“The initial results of our study are positive and significant”, stated Christopher J. Moreau, president and CEO of Miraculins Inc. “The potential impact of our test on healthcare costs would be dramatic. Last year, in the U.S. alone, there were 750,000 biopsies performed that produced negative results. At a cost of approximately US$2,000 per biopsy, every 10% reduction in unnecessary biopsies equals an annual cost savings of US$150 million.”
“These results are very significant”, commented Dr. Richard Casey, president and medical director of CMX Research Inc., and a leading urologist. “The development of a test by Miraculins that will help reduce the number of men who undergo unnecessary biopsies will be welcomed by clinicians who are concerned about the poor performance of PSA alone.”
When available, final results of the study will be published and presented at an appropriate medical conference.
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.
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 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. PlatformTM utilizes the concurrent analysis of clinical factors and biological data, and a combination of proteomic, mass spectrometric, and protein chemistry techniques for biomarker discovery.
SOURCE: Miraculins Inc |
