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NEOPROBE : Lymphoseek Data Presented at International Sentinel Node Society Annual Meeting

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11/18/2010 | 04:55pm CEST

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that investigators are presenting data and insights on Lymphoseek® use in lymph node mapping and biopsy at the International Sentinel Node Society (ISNS) Bi-Annual Meeting in Yokohama, Japan November 18-20, 2010 (www2.convention.co.jp/isns2010). ISNS is the largest international meeting highlighting scientific discovery and implementation of the latest technologies to improve and advance lymphatic mapping to help improve patient diagnosis, treatment and care. Lymphoseek presentations made at ISNS will highlight its value in clinical oncology, including the utility of the agent in lymphatic mapping in breast cancer and melanoma patients, review of the development and successful performance of Lymphoseek in clinical trials to date, and the outlook for potential development of next-generation formulations of the compound.

?Lymphoseek presentations at ISNS 2010 signal an important step in the international clinical community's interest in the technology's potential to improve lymph node mapping and patient treatment and care, and the growing importance of accurate intra-operative identification of sentinel lymph nodes in surgical oncology,? said Dr. Frederick O. Cope, Senior Vice President of Pharmaceutical Research and Clinical Development of Neoprobe. ?We look forward to working with international clinical leaders to advance the evidence of Lymphoseek's clinical utility to help improve diagnosis in melanoma, breast, head and neck cancer and other solid tumor cancers.?

Lymphoseek data and scientific presentations at ISNS 2010 included or are scheduled to include:

?Development and Performance of [99mTc] Tilmanocept as a Sentinel Lymph Node Mapping Agent,? Dr. A. Wallace, et al.

This session will be the first time a comprehensive overview of Lymphoseek clinical data and drug development chronology have been presented at a major medical meeting.

Dr. Wallace will review the results of all completed clinical trials of Lymphoseek to date, including initial efficacy data in three Phase 1 studies in breast cancer and melanoma patients. Additionally, Dr. Wallace's presentation will review the results of the multicenter Phase 2 and Phase 3 Lymphoseek clinical trials that demonstrated significantly high concordance rates versus vital blue dye and rapid lymph node uptake permitting earlier, typically immediate, lymphoscintigraphy imaging. Lymphoscintigraphies are nuclear medicine imaging procedures intended to preoperatively identify lymph nodes draining from a tumor site.

The NEO3-05 Phase 3 study was an open label trial of node-negative subjects with either breast cancer or melanoma. It was designed to evaluate the safety and the accuracy of Lymphoseek while identifying lymph nodes draining from the subject's tumor site. To demonstrate the accuracy of Lymphoseek, each subject consenting to participate in the study was injected in proximity to the tumor with Lymphoseek and one of the vital blue dyes that are commonly used in lymphatic mapping procedures. The primary efficacy objective of the study was to identify lymph nodes that contained the vital blue dye and to demonstrate a statistically acceptable concordance rate between the identification of lymph nodes with the vital blue dye and Lymphoseek. To be successful, the study needed to achieve a statistical p-value of at least 0.05. The protocol compliant clinical sites that participated in the NEO3-05 study contributed 136 Intent-To-Treat (ITT) subjects who provided 215 lymph nodes that contained the vital blue dye. 210 of the vital blue dye positive lymph nodes contained Lymphoseek for an overall concordance rate of 98%, achieving a highly significant statistical p-value of 0.0001. In addition to the nodes identified by vital blue dye and Lymphoseek, Lymphoseek was able to identify 85 additional lymph nodes that did not contain the vital blue dye, and 18% of these nodes were found by pathology to contain cancer, pointing to the agent's ability to identify lymph nodes containing occult tumors that can be missed by conventional diagnostic methods.

The data further show that in all the Phase 1 through Phase 3 studies, there were no significant safety events in any study related to Lymphoseek. In all studies, Lymphoseek fulfilled its performance objective relative to its prospective bio-targeting design toward discerning lymphatic tissue in intra-operative lymphatic mapping.

?A Phase 2 Clinical Study of 99mTc-Lymphoseek in the Identification of Sentinel Lymph Nodes in Melanoma and Breast Cancer,? Dr. R.C. Orahood, et al.

Dr. Orahood will present findings from the previously announced Phase 2 study of Lymphoseek in lymphatic mapping procedures in 78 clinical subjects with either breast cancer (31 subjects) or melanoma (47 subjects). The study evaluated the agent's efficacy in intra-operative identification of lymph nodes draining primary breast cancer or melanoma malignancies.

As previously reported, Lymphoseek identified ?hot spots? in 94.5% of patients in nuclear medicine imaging studies prior to surgery. Intra-operatively, Lymphoseek identified at least one regional lymph node in 75/78 subjects (96.2%); 46/47 (97.9%) in melanoma and 29/31 (93.5%) in breast cancer, confirming its high level of performance in this diverse set of cancers. Overall sensitivity by node was 92.0% with a corresponding 8% false negative rate. Five serious adverse events occurred; none were related to the investigational drug.

?A Receptor-Targeted Fluorescent Radiopharmaceutical for Multi-Modality Sentinel Lymph Node Mapping at Multiple Spatial Scales,? Dr. David Vera, et al.

Dr. Vera and colleagues will showcase pre-clinical results from initial studies investigating a fluorescent formulation of Lymphoseek and the potential utility of this formulation for use in lymph node mapping for cancer diagnosis. The studies being presented at ISNS are intended to demonstrate the feasibility of sentinel lymph node mapping with a hand-held fluorescence detector and fluorescent imaging agent.

In addition, Lymphoseek is expected to be discussed at length in four additional panel discussions at the ISNS conference.

?We are pleased to have Lymphoseek so prominently recognized at the ISNS Bi-Annual Meeting,? said David Bupp, President and CEO of Neoprobe. ?The presentation of this data underscores our belief in the merits of Lymphoseek to significantly improve patient care in the treatment of life-threatening diseases.?

About Neoprobe

Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan? CR. Neoprobe's subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe's strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic biomedical markets through continued investment and selective acquisitions. www.neoprobe.com

Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company's plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company's products are forward-looking statements The words ?believe,? ?expect,? ?anticipate,? ?estimate,? ?project,? and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company's continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company's most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.

Neoprobe Corporation
Brent Larson, 614-822-2330
Sr. Vice President & CFO
Makovsky + Company
Gene Marbach, 212-508-9645

© Business Wire 2010
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