Breast Cancer test on the move again and so is the stock..
Matritech Inc NASDAQ NM: NMPS Last Update: 8:59:00 AM ET May 23, 2001
Study to be conducted at 6 sites; 1000 patients to be tested
NEWTON, Mass., May 23, 2001 /PRNewswire via COMTEX/ -- Matritech, Inc. (NMPS), the cancer diagnosis company, announced today that it has begun patient recruitment for a multi-center clinical study of its NMP66 blood test for the early detection of breast cancer.
The clinical study, which will be conducted at 6 medical centers around the country, will enroll approximately 1,000 patients. It will include about 700 women with lesions which are either visible on mammogram, or palpable, and who have been recommended by their physicians to have a further diagnostic procedure such as biopsy. An additional 300 women with normal mammograms will also be recruited. The trial will investigate the ability of the NMP66 blood test to detect cancer, differentiate between benign and malignant lesions, and identify patients with normal mammograms. The goal of the study is to investigate the NMP66 blood test as a potential future screening procedure for breast cancer.
"The key to fighting and treating breast cancer is early detection," said David L. Corbet, President and Chief Operating Officer of Matritech. "According to the American Cancer Society, five-year survival for women in whom the disease is detected at its earliest stage is greater than 96 percent. However, survival for this length of time decreases to 21 percent in women with late-stage, metastatic disease."
"Despite the encouraging progress that the medical community has made in detecting breast cancer, only 62 percent of breast cancers diagnosed between 1989 and 1995 were found while still localized," added Corbet. "While mammography is still the best detection method, the number of false positives is high. Clearly, there is a need for a blood-based screening tool to enhance existing methods of detecting breast cancer, and NMP66 has the potential to fulfill this role."
"This is the type of test my patients have been hoping to use for over twenty years," said Avi Ben-Ora M.D., a radiologist and former president of the Arizona division of the American Cancer Society. "Because almost half the women in the U.S. who should be getting annual mammograms are not, there is a critical need for a serum-based test for breast cancer screening. Once the performance of NMP66 is proven and becomes available, mammography and breast ultrasound would only be needed for the specific localization of abnormalities, and the number of unnecessary biopsies could be sharply reduced."
"We anticipate an overwhelming response by patients. What woman wouldn't want a blood test for breast cancer?" said V. Suzanne Klimberg, M.D., the lead investigator on the trial, Director of the Breast Cancer Program and Chief of the Division of Breast Surgical Oncology at the Arkansas Cancer Research Center. "As a surgeon and researcher, I'm also interested in other possible uses for a test like this, such as identifying cancers not visible on mammogram, or determining if a patient has residual disease after surgery or chemotherapy, when it is still treatable and before it can spread further."
Last year, Matritech reported proof of clinical concept results for NMP66 in the detection of breast cancer. Using Matritech's proprietary specimen preparation and mass spectrometry procedures, NMP66 was found in all samples from women with invasive breast cancer, and was absent in all "normal" specimens. This data was presented last month in Santa Barbara, Calif. at the 2nd Tumor Markers Conference sponsored by the M.D. Anderson Cancer Center in Houston.
Detection of these breast cancer markers in blood was accomplished using a novel approach for cancer marker detection, mass spectrometry, a technique which the Company believes is immediately applicable to other cancer tests it is developing. Mass spectrometry techniques for measuring the elevation of specific proteins in blood is expected to improve the accuracy of the tests in development by Matritech as well as expedite the introduction of second generation, blood-based cancer diagnostic tests to clinical laboratories worldwide. In addition to the mass spectrometry format, Matritech is pursuing antibody-based immunoassays compatible with existing clinical laboratory instrumentation.
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 pipeline of NMP-based products in development for the detection of major cancers including cervical, breast, colon and prostate cancers. The NMP22 Test Kit for bladder cancer is cleared for marketing in the United States for management and screening of individuals at risk of bladder cancer. It also is sold in China, Europe and Japan where it is approved for bladder cancer screening.
Matritech, Inc., based in Newton, Mass., is using its 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, colon and prostate cancers. |