The tests and approvals are in the works. The sales seem to be the
least of the worries, based on the accuracy of the nmp technology. The
exposure dept has heeded the monk requests. Better late than never...
Matritech begins clinical trials of blood based colorectal cancer test
Preclinical evaluation shows improved sensitivity compared to CEA
NEWTON, Mass., Oct. 2 /PRNewswire/ -- Matritech, Inc.
(Nasdaq: NMPS; BSE: MPS) announced today that it has begun clinical trials for
the purpose of providing the Food and Drug Administration (FDA) data upon
which to base approval for sale of its Colorectal cancer test in the United
States. This is the second Nuclear Matrix Protein (NMP) based immunoassay
developed by Matritech.
Matritech's pilot study evaluation of the test demonstrated that its NMP
based colorectal cancer test is more than twice as sensitive as the FDA-
approved carcinoembryonic antigen assay (CEA) in identifying colorectal
cancer, the second-leading cause of cancer-related deaths in the United
States.
"The reported mortality from colon cancer after five years is estimated to
be 50 percent," said David L. Corbet, president of Matritech. "Clinicians
believe that detecting recurrence of colorectal cancer in an early, localized
stage significantly reduces mortality. Given the high sensitivity of
Matritech's test in pilot studies, our final colorectal cancer test could make
a major contribution to the care of colorectal cancer patients," Corbet added.
"We intend to start selling our colorectal cancer test outside of the U.S.
this year."
Only one blood based clinical assay, CEA (carcinoembryonic antigen assay),
has received marketing approval from the FDA for monitoring colorectal cancer
patients. Worldwide sales of CEA are estimated by Matritech to exceed
$100 million annually. However, a Matritech study, presented at the annual
meeting of the American Association for Cancer Research (AACR) in April,
demonstrated CEA to be elevated in 33 percent (8/24) of samples from patients
with documented early stage (Dukes A, B1, B2) colorectal cancer. The
Matritech test was elevated in 71 percent (17/24) of those samples.
The Company also announced that Matritech and Yamanouchi Pharmaceuticals
Co. Ltd. have jointly agreed that Yamanouchi will not be Matritech's
distribution partner for its colorectal test in Japan. The two companies have
decided not to proceed because a colorectal assay is not consistent with
Yamanouchi's tumor marker strategy. Matritech is in the process of discussing
its colorectal test with other distributors in Japan.
The colorectal cancer test is Matritech's second NMP-based assay. The
Matritech NMP22(R) Test Kit -- the only quantitative bladder cancer test
commercially available for sale in the U.S. -- is approximately twice as
sensitive as urine cytology and is a painless, low-cost and highly accurate
tool for the prognosis of transitional cell carcinoma (TCC) of the urinary
tract, which accounts for more than 90 percent of bladder cancer.
Both the colorectal cancer test and the Matritech NMP22 Test Kit are based
on a fundamental breakthrough in cell biology discovered at the Massachusetts
Institute of Technology (MIT), where researchers found that NMPs in cancer
cells differ from those in normal cells. MIT obtained three patents covering
the use of NMPs to detect cancer and licensed their discovery worldwide,
exclusively, to Matritech.
In addition to bladder and colorectal cancer, Matritech's pipeline also
includes plans to develop products for detecting lung, breast, prostate and
cervical 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 NMP market to itself.
CONTACT: Stephen D. Chubb, CEO or David L. Corbet, President of Matritech, Inc.,
617-928-0820, or Ronald C. Trahan, President of Ronald Trahan Associates, Inc.,
508-651-1180 |
