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Neoprobe announces the beginning of a multi-phase breast cancer diagnosis and treatment initiative.


DUBLIN, Ohio--(BUSINESS WIRE)--Nov. 21, 1996--Neoprobe Corporation (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
 NMS See NetWare Management System. :NEOP NEOP Neoprobe Corporation (stock symbol)
NEOP Near Earth Object Program
NEOP New England Order of Protection
NEOP Nuclear Explosive Operating Procedure
) recently announced that all phases of its breast cancer initiative are now underway, including a RIGS(R) technology surgical detection product, a RIGS/ACT(R) (activated cellular therapy) program, and the intraoperative lymphatic lymphatic /lym·phat·ic/ (lim-fat´ik)
1. pertaining to lymph or to a lymphatic vessel.

2. a lymphatic vessel.


lym·phat·ic
adj.
 mapping (ILM) procedure.

Neoprobe's RIGS technology program received permission from the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) to open a study with breast cancer patients. The study will evaluate an antibody fragment breast cancer targeting agent under a corporate Investigational New Drug (IND) application. The therapeutic program also began enrollment for a trial for breast cancer patients with RIGS/ACT. Furthermore, the Neoprobe(R) 1000 device is currently being used in multi-center trials evaluating ILM for breast cancer.

"We are pleased to get all phases of this initiative underway, as it is part of Neoprobe's overall commitment to help physicians better diagnose and treat breast cancer," said David Bupp, Neoprobe's president. "By providing surgeons with tools to improve the surgical detection of cancer and developing therapies for women who have exhausted other treatments, Neoprobe hopes to make strides to expand options for the 184,300 women in the U.S. alone who will be diagnosed with breast cancer this year."

The RIGS technology study will involve women who have biopsy-proven breast cancer and who will undergo a partial or total mastectomy mastectomy (măstĕk`təmē), surgical removal of breast tissue, usually done as treatment for breast cancer. There are many types of mastectomy. In general, the farther the cancer has spread, the more tissue is taken.  and an axillary ax·il·lar·y
n.
Relating to the axilla.


Axillary
Located in or near the armpit.

Mentioned in: Mastectomy


axillary

of or pertaining to the armpit.
 dissection. The RIGS system works by injecting a low-level radioactive, cancer-specific targeting agent into a cancer patient before surgery. For this study, it is a radiolabeled antibody fragment. During the operation, the surgeon uses a hand-held, gamma-radiation-detecting probe to locate diseased tissue that contains a significant amount of the radioactive targeting agent.

In addition, enrollment has begun in a Neoprobe-supported study examining the effects of RIGS/ACT in women who have failed prior therapy and cannot be cured by surgery. RIGS/ACT treats disease by using a patient's own lymphocytes to try to enhance the patient's immune response to the cancer. It is unique among cellular therapies in that the company's RIGS system is used to identify otherwise indistinguishable lymph nodes that contain an unusual number of the helper lymphocytes.

For breast cancer, these are peripheral nodes found in the axilla axilla /ax·il·la/ (ak-sil´ah) pl. axil´lae   [L.] the armpit.ax´illary

ax·il·la
n. pl. ax·il·lae
See armpit.
 (armpit arm·pit
n.
The hollow under the upper part of the arm below the shoulder joint, bounded by the pectoralis major, the latissimus dorsi, the anterior serratus muscles, and the humerus, and containing the axillary artery and vein, the infraclavicular part
). The lymph nodes are removed in an outpatient setting under local anesthetic, and the lymphocytes are grown in a laboratory. Within 10 to 14 days, 10 to 100 billion helper cells are infused back into the patient, with minimal side effects, to treat the disease. The infusion is also given as an outpatient procedure.

In a different procedure, surgeons throughout the United States are beginning to use Neoprobe's device for intraoperative lymphatic mapping. This procedure traces the lymphatic patterns in a patient to evaluate potential tumor drainage and metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases  
1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to
. Surgeons at some leading cancer centers consider ILM a procedure which provides the optimal level of care for patients with malignant melanoma, a dangerous form of skin cancer. Surgeons are also beginning to investigate the potential clinical benefit of using this procedure to prevent unnecessary total lymph node removal for breast cancer patients who have no spread of tumor.

"The surgical community has a great interest in applying the ILM technique to breast cancer, and Neoprobe is enthusiastic about supporting surgeons' research in this application of the technology," said Bupp. "Along with our worldwide marketing partner, United States Surgical Corporation, we have been looking at early market opportunities for ILM for breast cancer and are actively marketing our device for malignant melanoma."

Neoprobe Corporation, based in Dublin, Ohio, is dedicated to improving the diagnosis and treatment of cancer. The company is developing and commercializing products based on its patented RIGS technology for both surgical detection and activated cellular therapy for solid-tumor types of cancer. Neoprobe's goal is to develop products which improve the standard of care, enhance the quality of life and extend survival for cancer patients. Neoprobe's first product, RIGScan(R) CR49 for surgical detection of metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 colorectal cancer, is currently under review with European regulatory authorities. The company expects to submit a Biologic License Application (BLA BLA
abbr.
Bachelor of Liberal Arts
) to the FDA for the same product by the end of the year.

CONTACT: Neoprobe Corporation, Dublin

David C. Bupp, President

Judy Barnes, Corporate Communications Manager,

jbarnes@neoprobe.com

Beth Gonda, PR Associate,

bgonda@neoprobe.com

614/793-7500

NEOPROBE HOME PAGE:

http://www.neoprobe.com
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 21, 1996
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