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IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Vice
President / CFO
614
822 2330
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December
8, 2009
Tim
Ryan,
The
Shoreham Group
212
242 7777
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NEOPROBE
FILES PHASE 3 REPORT WITH FDA
Lymphoseek
End-of-Phase 3 Meeting Request Made
DUBLIN,
OHIO – December 8, 2009 -- Neoprobe Corporation (OTCBB: NEOP), a diversified
developer of innovative oncology surgical and diagnostic products, has completed
a Phase 3 clinical trial of Lymphoseek®
(NEO3-05) with positive results. The Phase 3 clinical trial was designed to
provide, and achieved its primary endpoint of, the evaluation of the efficacy of
Lymphoseek in anatomically delineating lymph nodes in both breast cancer and
melanoma patients that may be predictive of determining whether cancer has
spread into the lymphatic system. Based on these positive outcomes, Neoprobe has
submitted an end-of-Phase 3 meeting request to the US FDA to discuss the results
of the clinical trial as part of our continuing preparation of a New Drug
Application (NDA), which we plan to file later in 2010. The NEO3-05 study has
been closed on the national clinical trials website www.clinicaltrials.gov.
The
NEO3-05 clinical trial results confirmed the identification of lymphatic tissue
in patients with either breast cancer or melanoma as designed, and when used in
conjunction with and compared to vital blue dyes, showed a marked improvement in
this identification. Pathological assessment of lymphatic tissue removed during
surgery provided further prognostic value in determining the disease state. The
Phase 3 trial was designed to determine the accuracy of Lymphoseek to identify
lymphatic tissue as compared to commonly used vital blue dyes. The primary
objective of the Phase 3 was to obtain at least 203 lymph nodes identified with
the vital blue dyes and to statistically demonstrate that 94% of those nodes
were identified with Lymphoseek. Procedure-compliant patients in the trial
contributed 215 vital blue positive nodes and Lymphoseek identified 210 of those
nodes for a success rate of over 97%. In addition, Lymphoseek identified 85
lymph nodes that were missed by the vital blue dyes. Of these Lymphoseek
positive nodes, over 18% were found by pathology to contain tumor.
“The
filing of the end-of-Phase 3 report is an important milestone in the development
process for Lymphoseek”, said David Bupp, Neoprobe’s President and CEO. “We are
very pleased with the final results of the Phase 3 trial and we look forward to
meeting with FDA to discuss the results of the trial and to begin discussions
regarding the filing of the NDA to register Lymphoseek for commercial
distribution in the United States.”
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.