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Biotech / Medical : Matritech (NASDAQ - NMPS) -- Ignore unavailable to you. Want to Upgrade?


To: M.A. Caccavo who wrote (628)5/20/1998 11:46:00 AM
From: Damon Pham  Respond to of 849
 
Well, I guess they are trying to put something out to soften the FDA news. Wish they had done this before the bad stuff.

******
Researchers Present Preclinical Feasibility Study for Matritech's NMP179
as a Cervical Cancer Tumor Marker at American Society of Clinical
Oncology (ASCO)

(Copyright (c) 1998, PR Newswire)

NEWTON, Mass., May 20 /PRNewswire/ -- Matritech, Inc. (Nasdaq: NMPS)
announced today that data from a preclinical evaluation of NMP179 demonstrate
its ability to detect pre-cancerous cervical abnormalities with a high degree
accuracy. The study was presented at the American Society of Clinical
Oncology Conference (ASCO) meeting in Los Angeles. NMP179 is one of a series
of diagnostic products based on Matritech's proprietary technology, which
correlates the level of nuclear matrix proteins (NMPs) in body fluids to the
presence of cancer.
"The high levels of sensitivity recorded by NMP179 in this study and in
previous preclinical studies are a further indication that NMP179 may provide
physicians with an important tool for detecting early stage cervical
abnormalities," said Dr. Susan Keesee, Manager, Cell Biology at Matritech and
investigator on the study. "Although the Pap smear has long been considered
the standard for detecting cervical cancer, there are significant limitations
involved with tests which rely on visual interpretation. As a biochemical
marker, NMP179 has the potential to overcome many of these limitations and
provide an accurate and early diagnosis of patients who may not yet exhibit
visible abnormalities in cervical tissue samples."
The blinded, preclinical study presented at ASCO was conducted in
collaboration with Brigham and Women's Hospital, Boston, and Women and Infants
Hospital, Providence. In the study, researchers qualitatively assessed the
ability of the monoclonal antibody, NMP179, to recognize a nuclear matrix
protein (NMP) associated with cervical carcinoma in 212 cervical tissue
specimens. The results of the study indicated that NMP179 detected 100% of
precancerous high grade or advanced cervical dysplasia and 76.7% of
precancerous low grade or early stage cervical dysplasia.
The American Cancer Society estimates that 13,700 new cases of cervical
cancer will be diagnosed in the United States during 1998. Although cervical
cancer is one of the most treatable forms of cancer if detected early,
approximately 4,900 individuals will die of the disease in the U.S. this year alone. The Pap smear has been the standard diagnostic test for the detection
of cervical cancer since 1943.
Matritech, Inc., based in Newton, Mass., is using its proprietary nuclear
matrix protein (NMP) technology, discovered at the Massachusetts Institute of
Technology (MIT) 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,
colon, cervical, breast, and prostate cancers. The Company's lead product,
the NMP22(R) Test Kit for the management of bladder cancer patients, was
approved for sale by the Food and Drug Administration (FDA) in 1996.
Except for historical information contained herein, the matters discussed in
this news release are forward-looking statements that are subject to risks and
uncertainties. Potential risks and uncertainties include, without limitation,
risks related to the Company's ability to: successfully develop, test,
produce, and market its products; obtain necessary government approvals in a
timely manner; attract and keep key employees; raise capital for future
operations and growth; and successfully respond to technological changes in
the marketplace. Additional information on potential factors which could affect the Company's financial results are included in the Company's public
filings with the Securities and Exchange Commission.
/CONTACT: Stephen D. Chubb, CEO, or Susan Keesee, Scientific Officer of
Matritech, Inc., 617-928-0820 or Derek Caldwell of Sunrise Financial
Group, 212-421-1616 or Gretchen L. P. Schweitzer or Julia Rutherford of
Feinstein Kean Partners, 617-577-8110/



To: M.A. Caccavo who wrote (628)5/20/1998 11:48:00 AM
From: Damon Pham  Respond to of 849
 
More news and spin control.

*****

Matritech NuMA(TM) Test Kit FDA 510(k) Decision Has No Affect on Product
Approvability; Development On-Track

(Copyright (c) 1998, PR Newswire)

NEWTON, Mass., May 20 /PRNewswire/ -- Matritech, Inc. (Nasdaq: NMPS)
announced additional information on the determination from the U.S. Food and
Drug Administration (FDA) that its NuMA(TM) Test Kit for detecting colon
cancer does not meet the criteria for 510(k) marketing clearance.
"The FDA determination does not imply a decision about the approvability of
the product," said David L. Corbet, President of Matritech. "We continue to
be on-track with the Company's planned premarket approval application (PMA)
filing for the NuMA(TM) Test Kit product in early 1999."
"The 510(k) application strategy was an opportunistic approach to expedited
marketing clearance. Matritech is one of the first companies to try to use
newly effective tumor marker regulations to prove equivalence between two
completely different markers," Corbet continued. "The recent FDA decision was
based on our tests 'equivalence' to another test in a legal sense. This decision has nothing to do with ultimate approvability of the product. It has
also not delayed the PMA process in any way. This is a new and complex area
of interpretation, and we plan to continue discussions with our contacts at
the FDA on this topic."
"From the beginning of the regulatory process for NuMA, we have been
pursuing a dual-track regulatory strategy, which includes both a PMA filing
and a 510(k) filing, to ensure that we are able to expedite the approval of
the product," stated Mr. Corbet. "We have been pursuing a PMA filing as our
principal strategy, with the end goal being marketing clearance for screening
as well as the patient management indication."
The NuMA(TM) test kit is a blood-based assay that utilizes the Company's
nuclear matrix protein (NMP) technology for the management of colon cancer
patients. The test kit detects a specific NMP, NuMA, using proprietary
antibodies, to differentiate cancerous from normal specimens. Matritech has
retained worldwide manufacturing and marketing rights for NuMA. The NMP(R)22
Test Kit, approved by the FDA for sale in the United States in 1996, also uses
the NuMA protein.
Matritech, Inc., based in Newton, MA, is using its proprietary NMP technology, discovered at the Massachusetts Institute of Technology and
licensed exclusively to Matritech, to develop and commercialize innovative
serum-, cell-, and urine-based diagnostics that enable physicians to reliably
detect and monitor the presence of bladder, breast, cervical, colorectal and
prostate cancers. The Company's first product, the NMP-22 Test Kit for
bladder cancer, is on the market. All of Matritech's diagnostic assays are
based on the discovery that nuclear matrix proteins in cancer cells differ
from those in normal cells.
Any forward-looking statements related to the Company's expectations
regarding clinical trials and regulatory approvals 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 delays in
specimen collection, conduct of trials, analysis of data, preparation of FDA
submission and review and approval by the FDA and by other regulatory
authorities. There can be no assurance that the Company's current and future
products will obtain necessary regulatory approvals in a time period
consistent with the Company's past experience, or at all.
/CONTACT: Stephen D. Chubb, CEO, or David L. Corbet, President of Matritech, Inc., 617-928-0820 or Derek Caldwell of Sunrise Financial
Group, 212-421-1616/
09:04 EDT



To: M.A. Caccavo who wrote (628)5/20/1998 11:50:00 AM
From: Damon Pham  Respond to of 849
 
Matritech/FDA-2: 510(k) Rejection Doesn't Hurt Approvability

(Copyright (c) 1998, Dow Jones & Company, Inc.)

NEWTON, Mass. (Dow Jones)--Matritech Inc.'s (NMPS) premarket approval
application filing with the Food and Drug Administration for its NuMA
Test Kit for colon cancer is "on track" for approval early in 1999.
In a press release Wednesday, Matritech said the FDA's decision to
reject NumMA for for 510(k) marketing clearance "does not imply a
decision about the approvability of the product."
The 510(k) clearance is given when a product is found to be
substantially similar to another product that has already received FDA
clearance.
Martritech said its 510(k) application was an attempt to speed up
marketing clearance.
The company said it is one of the first concerns to try to use new
regulations on tumor markers to prove equivalence between two completely
different markers.

The FDA's decision on the 510(k) was based on Matritech's test's
"equivalence" to another test in a legal sense, Matritech said.



To: M.A. Caccavo who wrote (628)5/20/1998 11:53:00 AM
From: Damon Pham  Respond to of 849
 
FDA Ruling Not Big Impediment, Analyst Says

(Copyright (c) 1998, Dow Jones & Company, Inc.)

Gary B. Davis, an analyst at Jesup & Lamont Securities, said the FDA
510(k) ruling doesn't necessarily represent a major problem for
Matritech because the company also is pursuing pre-market approval for
NuMA.
The decision is "no reflection on the safety or efficacy of the
products," he said.
The analyst estimates that the 510(k) rejection will cause a delay of
six to nine months in the market introduction of NuMA.
Further, Davis said the NuMA test is only "one of multiple products,"
offered by Matritech, and that a delay in its release will not affect
the company's performance severely.
Company officials were not immediately available for comment.