New Data Report Matritech's NMP48 Prostate Cancer Blood Test More Accurate than PSA; NMP48 Test Could Reduce Unnecessary Biopsies

Business Wire, Dec 10, 2001

Business Editors and Health/Medical Writers

NEWTON, Mass.--(BW HealthWire)--Dec. 10, 2001

A new blood test for the detection of prostate cancer developed by Matritech Inc. (NASDAQ: NMPS) correctly identified men with benign prostate disease (BPH) as negative for prostate cancer. These results are a significant improvement over the widely used prostate specific antigen (PSA) test, which often produces false-positive results for men with BPH. Matritech presented the NMP48(TM) prostate cancer test results at the New Discoveries in Prostate Cancer Biology and Treatment meeting, hosted by the American Association for Cancer Research. All blood samples used in the testing were provided by the Urology Department at The Johns Hopkins Hospital.

"The discovery of the NMP48 protein and the resulting test should significantly improve the process for diagnosing prostate cancer," said Matritech's senior protein chemist John J. Hlavaty, Ph.D, who leads the Matritech discovery team. "PSA, the current test, often incorrectly appears positive in men with benign disease because the PSA test is not cancer-specific. These men must then endure invasive testing, including biopsy of the prostate, which is a painful and expensive procedure. It appears that NMP48 may reduce these unnecessary and expensive procedures."

Blood specimens from 15 men with BPH were tested. PSA results were sufficiently elevated for 12 of these men to indicate the possibility of prostate cancer. Matritech's NMP48 test correctly identified 14 of the 15 men who did not have prostate cancer.

These results indicate that NMP48 is more specific than the PSA test for ruling out prostate cancer. Previous presentations made this year by Matritech scientists at clinical meetings have reported greater sensitivity of NMP48 in detecting prostate cancer than PSA.

The data included more than 125 serum samples (including BPH and post-surgery samples) that were analyzed using Matritech's proprietary sample processing and mass spectrometry discovery method. The study included blood from 52 men who previously had been diagnosed with prostate cancer and compared the results to the blood of 50 healthy men. NMP48 was found in 96 percent of the men diagnosed with prostate cancer. NMP48 also identified 11 of 12 men with biopsy-confirmed prostate cancer that were missed by the PSA test.

NMP48 was also present in only two of 10 post-surgery blood samples, suggesting that NMP48 may be useful to monitor for recurrence of prostate cancer.

"The clinical value of this biomarker is its improved overall accuracy over PSA in detecting prostate cancer. In these studies, NMP48 has been shown to be both more sensitive and specific than the PSA test," said Hlavaty. "Using this proteomic technology, we are developing a clinical format for NMP48 to permit urologists to detect cancer earlier and to save lives."

According to the American Cancer Society, an estimated 198,100 new cases of prostate cancer will be diagnosed in the United States this year, and an estimated 31,500 men die from prostate cancer annually. The five-year survival rate approaches 100 percent when the disease is detected early. The most life threatening, late-stage forms of prostate cancer often require surgical removal of the prostate, which can lead to complications such as impotence and incontinence.

About Matritech

Matritech is a leading developer of proteomics-based diagnostic products for the early detection of cancer. Using its patented proteomics technology, Matritech has identified proteins correlated with breast, bladder, prostate, cervical and colon cancers. Matritech is one of the first companies to successfully employ proteomics to create diagnostic products. The Company holds one of only two FDA product approvals for the initial detection of cancer. The FDA-approved NMP22 bladder cancer test is currently used by urologists. In addition, the Company has a promising blood-based breast cancer test, NMP66, in clinical trials. Initial research on a prostate cancer marker, NMP48, identified by Matritech scientists shows the marker to be more accurate than the widely used PSA test. NMP technology is licensed exclusively to Matritech from the Massachusetts Institute of Technology.

Statement Under the Private Securities Litigation Reform Act

Any forward-looking statements related to the Company's expectations regarding its current and future products 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 unforeseen technical obstacles in completing clinical trials, unforeseen delays in, or denials of, FDA and other regulatory approvals, future product demand and pricing performance of distributors, competitive products and technical developments, health care reform and general business and economic conditions. There can be no assurance that the Company's expectations for its products will be achieved.