Matritech Reports 'Proof of Clinical Concept' For Breast Cancer Blood Test
Is Complete
PR Newswire - June 01, 2000 09:21
All cases of cancer were detected by the NMP66' test
NEWTON, Mass., June 1 /PRNewswire/ -- Matritech, Inc. (Nasdaq: NMPS), a
company specializing in products designed to detect, manage and screen for
cancer, today announced that it has completed the 'proof of clinical
concept' of its proprietary NMP66 blood test for women with, or at risk of,
breast cancer. The NMP66 test is based on the Company's nuclear matrix
protein (NMP) technology platform, which correlates levels of NMPs in body
fluids to the presence of cancer.
Led by Matritech scientist Brynmor Watkins, Ph.D., 78 specimens have been
tested using Matritech's proprietary specimen preparation and mass
spectrometry procedures. 45 of these specimens came from women diagnosed
with breast cancer in various stages of the disease and 5 were from women
with Ductal Carcinoma In Situ (DCIS), a condition that can progress to
cancer. An additional 28 specimens came from women who were normal or had
been diagnosed as having benign disease. NMP66 was found in the blood of
every woman who was diagnosed with cancer and was absent in all of the
'normal' specimens.
The results of the NMP66 testing are as follows:
Advanced metastatic disease 21 out of 21 detected
Newly diagnosed metastatic disease 5 out of 5 detected
Greater than 1 lymph node involved 8 out of 8 detected
1 lymph node involved 6 out of 6 detected
No lymph nodes involved 5 out of 5 detected
DCIS 4 out of 5 detected
Normal and benign disease 26 out of 28 ruled out
"We are extremely encouraged by the accuracy of our breast cancer markers
during this proof of clinical concept testing," said David L. Corbet,
President and Chief Operating Officer of Matritech. "We detected every case
of cancer, and ruled out cancer for all normal samples. Based on this
impressive accuracy, we consider 'proof of concept' complete.
"When breast cancer is discovered at its earliest stage, the five-year
survival rate is well over 90 percent," added Corbet. "Further testing and
development of this breast cancer blood test is therefore a high priority
for Matritech going forward."
"The current standard of care, mammography, can miss cancers, especially in
younger women. In addition, since women who undergo the procedure often
report discomfort, many others do not bother to be tested at all," said
Melodie Domurad, Ph.D., vice president of clinical and regulatory affairs at
Matritech. "Further, because mammograms are subject to interpretation, there
exists the possibility of error. We believe that the clinical value of
NMP66, as an additional method to detect and manage the treatment of women
with breast cancer, is enormous."
"If a test with high sensitivity and specificity levels, like the NMP66,
were developed, patient management would be significantly enhanced through
earlier cancer detection, leading to fewer deaths," said Dr. Margaret
Kemeny, chief of surgical oncology and executive medical director of the
Carol M. Baldwin Breast Care Center at the State University of New York,
Stony Brook.
The NMP66 test kit will be protected by claims contained in three patents
issued to the Massachusetts Institute of Technology and licensed exclusively
to Matritech. The Company recently filed four additional patents claiming
the use of this, and other NMPs, in the management of women with breast
cancer.
Matritech scientists determined the identity and partial amino sequence of
NMP66. It is a member of a class of NMPs that regulate the splicing of pre-
mRNA, a critical event in the development of all eukaryotic cells, including
those that progress to become malignant.
Matritech's nuclear matrix protein (NMP) core technology correlates levels
of NMPs in body fluids to the presence of cancer. Multiple published
clinical studies have validated this ability of NMPs to detect early-stage
cancerous abnormalities. Matritech has a deep pipeline of NMP-based products
in pre- clinical and clinical development for the detection of major cancers
including bladder, cervical, breast, prostate and colon cancers. The NMP22
Test Kit is cleared for marketing in the United States for management and
screening of individuals at risk of bladder cancer. It is also sold in
Europe and Japan, where it is approved for bladder cancer screening.
Matritech Inc., based in Newton, Mass., is using its proprietary nuclear
matrix protein (NMP) technology, discovered at the Massachusetts Institute
of Technology, and licensed exclusively to Matritech, to develop and
commercialize innovative serum-, cell- and urine-based NMP diagnostics that
enable physicians to reliably detect and monitor the presence of bladder,
cervical, breast, prostate and colon cancers.
Statement Under the Private Securities Litigation Reform Act
Any forward looking statements related to the Company's expectations
regarding the performance, timing or extent of market acceptance, and
regulatory approvals of the Company's breast cancer test are subject to a
number of risks and uncertainties, many of which are beyond the Company's
control. These include, but are not limited to, risks related to the
Company's limited capital resources, unforeseen delays in product
development, results of full-scale clinical trials, unforeseen delays or
denials of FDA and other regulatory approvals, future product demand and
pricing, competitive products and technical developments and general
business and economic conditions. There can be no assurances that the
Company's expectations for its products will be achieved.
SOURCE Matritech, Inc.
/CONTACT: Stephen D. Chubb, CEO or David L. Corbet, President of
Matritech, Inc., 617-928-0820, or Derek Caldwell, Investor Relations of
Sunrise Financial Group, 212-421-1616, or Jon Siegal, Media Relations of
Ronald Trahan Associates, Inc., 617-332-0101, ext. 15/
/Web site: matritech.com |
