NEWTON, Mass., July 19 /PRNewswire/ -- A new diagnostic test that
has been approved for sale in the U.S. by the FDA -- the Matritech
NMP22(R) Test Kit, developed by Matritech, Inc.
(Nasdaq: NMPS; BSE: MPS) -- to detect bladder cancer, was 100 percent
sensitive in identifying clinical trial patients who were found to have
the invasive form of the disease. These data are included in a study
published in the August 1996 issue of journal of Urology, "Use of a new
tumor marker, urinary NMP22, in the detection of occult or rapidly
recurring transitional cell carcinoma of the urinary tract following
surgical treatment," by Mark S. Soloway, et al.
"The purpose of our study," Dr. Soloway explained, "was to evaluate
the ability of urinary NMP22 values obtained approximately 10 days after
surgery to predict subsequent disease status. Ninety subjects underwent
transurethral resection (TUR) for transitional cell carcinoma (TCC) and
submitted a urine sample for NMP22 analysis 5 to 60 days after surgery.
Disease status was determined 3-6 months later at the next cystoscopic
examination. At a reference value of 10 U/ml, the NMP22 assay
identified 100 percent of patients (i.e., 6/6) who had invasive disease
at that exam.
"These results indicate that NMP22 is a powerful adjunct in the
management of bladder cancer. Patients with high NMP22 values are at
significant risk for exhibiting disease within three to six months,"
said Dr. Soloway, a leading authority on bladder cancer, who expects
that Matritech's urine assay will make a "very significant contribution"
to improving the care of patients monitored regularly for the recurrence
of bladder cancer.
On July 8, 1996, Matritech announced that the company's pre-
marketing application for the NMP22(R) Test Kit has been approved by the
Food and Drug Administration (FDA) for use in identifying patients at
risk for recurrence of bladder cancer following surgical treatment. The
Matritech NMP22 Test Kit is the first Nuclear Matrix Protein (NMP)-based
diagnostic product to complete the pre-market approval process.
The Matritech NMP22 Test Kit's enabling technology is based on a
fundamental breakthrough in cell biology discovered at the Massachusetts
Institute of Technology (MIT), where researchers found that Nuclear
Matrix Proteins (NMPs) in cancer cells differ from those in normal
cells. MIT obtained patents covering the use of NMPs to detect cancer
and licensed their discovery worldwide, exclusively, to Matritech.
In addition to the bladder assay, already in Matritech's pipeline
are products for detecting colorectal, prostate, cervical and breast
cancers -- all of which are based on discoveries that the protein
composition of the Nuclear Matrix differs between cancer cells and
normal cells. The medical market for those assays is estimated to be
more than $1 billion per year -- and, because of MIT's patents,
Matritech is expected to have the commercial Nuclear Matrix Protein
market to itself.
CONTACT: Mark S. Soloway, M.D., Chrmn., Dept. of Urologic Oncology of University of
Miami, 305-243-6596, or Stephen D. Chubb, CEO, or David L. Corbet, President of
Matritech, Inc., 617-928-0820, or Ronald C. Trahan, President of Ronald Trahan Assoc.,
508-651-1180; Other media sources: Gennaro A. Carpinito, M.D., Chief of Urology of Boston
City Hospital, 617-534-4123, or Donald Lamm, M.D., Chairman, Department of Urology of
West Virginia University, 304-293-2706, or Daniel B. Rukstalis, M.D., Chief of Urology of the
Medical College of Pennsylvania, 215-842-6568, or Lance Willsey, M.D., Clinical Fellow of
Harvard Univ. School of Medicine, 617-726-1818, or Edward Messing, M.D., Professor and
Chairman, Department of Urology of Univ. of Rochester Medical Center, 716-275-3345 |
