Miraculins''s PCSC04 study returns positive re
Miraculins's PCSC04 study returns positive results
2007-05-28 09:18 ET - News Release
Mr. Christopher Moreau reports
MIRACULINS ANNOUNCES POSITIVE FINAL RESULTS IN PIVOTAL PROSTATE CANCER BIOMARKER STUDY
Miraculins Inc. has provided the final results from its PCSC04 study.
PCSC04 was a prospective study of 200 preprostate 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 have shown that the Miraculins urine-based test performed with a specificity that would have eliminated approximately 23 per cent of the biopsies for patients who did not have prostate cancer. The test performed with a sensitivity that correctly identified 93 per cent 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 in Stockwatch 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 three 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 chief executive officer 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 Mr. 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's 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 Mr. 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-hour 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. Casey
Dr. Casey, MD, FRCS (C), 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.
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