DiagnoCure releases preliminary uPM3 test results
DiagnoCure Inc CUR
Shares issued 18,823,544 Feb 19 close $1.35
Wed 20 Feb 2002 News Release
Mr. Pierre Desy reports
DIAGNOCURE ANNOUNCES POSITIVE PRELIMINARY UPM3 TRIAL RESULTS
DiagnoCure has released initial results from a multicentre study of its
uPM3 test to detect PCA3(DD3) RNA expression in prostate cancer cells
present in urine. The results are a first step toward the company's goal of
establishing a new and more reliable test to detect prostate cancer.
"These encouraging results supplement DiagnoCure's March, 1999, pilot study
that demonstrated a number of key potential benefits associated with uPM3.
The new data shows superior sensitivity and relatively comparable
specificity. The original proof-of-concept study had a smaller sample size,
used a preliminary manual format of the test and included a substantial
number of urine samples from normal men that created higher average
specificity values," said Pierre Desy, president and chief executive
officer. "We expect that, as we refine the test, its performance will
continue to improve. Ultimately, we anticipate having a novel and flexible
approach to the lucrative prostate cancer market that decreases the number
of unnecessary biopsies."
During 2001, there were approximately 30 million PSA tests conducted
worldwide, representing a market of approximately $1-billion (U.S.). In the
United States, the world's largest health care market, the Food and Drug
Administration (FDA) recently approved routine screening for prostate
cancer for that country's 35 million strong male population over the age of
50 years.
The preliminary results announced today are based on a population of 239
urine samples from men undergoing transrectal ultrasound guided biopsy of
the prostate. Two-thirds of these patients have PSA levels between four and
10 ng/ml -- the problematic range for the PSA test, currently the standard
of prostate cancer testing. The PSA test, due to its approximate
25-per-cent specificity, produces a three-in-four false positive rate that
results in an excessive number of unnecessary biopsies. The initial results
from men with either confirmed prostate cancer or benign prostate
hyperplasia (BPH), yielded a sensitivity range among the different
participating centres of 75 per cent to 90 per cent with a specificity
range of 31 per cent and 64 per cent.
The latest version of the uPM3 test, used in this trial, incorporates
real-time detection using Beacons technology and the Easy Q instrument
supplied by Organon Teknika BV, a subsidiary of bioMerieux S.A. The new
test also retains the NASBA and Boom technologies from the original test.
The enhanced configuration provides a more sensitive and flexible tool that
can be easily introduced in clinical laboratories and may become the
foundation for other molecular diagnostic tests, beginning with a product
to detect lung cancer.
"These latest results will pave the way for DiagnoCure's regulatory
approach, which is being finalized in preparation for discussions with the
FDA prior to commencing pivotal clinical trials in the second half of
2002," said Dr. Yves Fradet, executive vice-president and chief scientific
officer. "In addition, the results have been submitted by our investigators
for presentation at an important upcoming international urology meeting."
In preparation for the anticipated FDA trial, the remainder of the data
from the preliminary trial will be compiled and analyzed while DiagnoCure
continues to optimize the automated version of the uPM3 test.
At 10:30 a.m. today a live audio Webcast of a conference call related to
the information in this release will be available through
www.diagnocure.com and www.financialdisclosure.ca. Please connect to one of
these Web sites at least 15 minutes prior to the conference call to ensure
adequate time for any software download that may be needed to hear the
Webcast. A replay of the Webcast will be available for 90 days starting on
Feb. 20, 2002, at www.diagnocure.com and www.financialdisclosure.ca. A
replay of the conference call will also be available by telephone from
approximately 12 noon (Eastern Time) on Feb. 20, 2002, through Feb. 27,
2002. To access the replay, dial 1-800-408-3053 or 416-695-5800 and enter
reservation No. 1089067.
(c) Copyright 2002 Canjex Publishing Ltd. stockwatch.com |
