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IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Vice
President / CFO
614
822 2330
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March
11, 2010
Tim
Ryan,
The
Shoreham Group
212
242 7777
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NEOPROBE
ANNOUNCES SUCCESSFUL MEETING ON LYMPHOSEEK PHASE 3 RESULTS
Submission
Plan for New Drug Application for Lymphoseek Reviewed With FDA
Conference
Call Scheduled for 8:30 a.m. tomorrow, Friday, March 12, 2010
DUBLIN,
OHIO – March 11, 2010 - Neoprobe Corporation (OTCBB: NEOP), a diversified
developer of innovative oncology and surgical diagnostic and treatment products,
today announced that it recently met with the United States Food and Drug
Administration (FDA) to review the clinical trial results of a Phase 3
investigational new drug, Lymphoseek®. The
Phase 3 clinical study (NEO3-05) was conducted in subjects diagnosed with either
breast cancer or melanoma. The FDA review included the efficacy and safety
results of the NEO3-05 study and Neoprobe’s plans for the submission of a New
Drug Application (NDA) for Lymphoseek. The NDA submission will be based on the
clinical results of NEO3-05 and other already completed clinical evaluations of
Lymphoseek. FDA encouraged Neoprobe to request a series of pre-NDA meetings in
the coming months to review the components of the NDA prior to its formal
submission. Neoprobe indicated to FDA that the Company plans to
submit the NDA following satisfactory completion of these meetings.
“We are
very pleased with our recent discussions with the FDA review team regarding the
NEO3-05 Phase 3 clinical results,” said David Bupp, Neoprobe’s President and
CEO. “The results from this meeting have clearly confirmed our
pathway for the submission of a NDA approximating our previously disclosed
target timeline. The potential clearance of the NDA in 2011 would position
Lymphoseek to be the first radiopharmaceutical for the preoperative or
intraoperative identification of lymphatic tissue. Neoprobe will be working with
FDA in the coming months to prepare for a successful review of the Lymphoseek
NDA, and to determine additional information that could be provided on a
post-marketing basis to extend or expand the labeling from that planned for the
initial NDA.”
“The
performance of Lymphoseek in the Phase 3 study was excellent,” said Dr. Fred
Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical
Development. “The primary and secondary efficacy end points of the study were
met and no significant adverse events were reported that were directly
attributed to Lymphoseek. The results of the Phase 3 trial have been favorably
received by the members of the medical and scientific community. We plan to
continue ongoing clinical evaluations of Lymphoseek that will be supportive of
the NDA and subsequent amended claims for the product.”
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 the 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.
In this
review meeting with FDA, the full analysis of the NEO3-5 clinical data was
discussed. 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 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. There were no significant safety events
related to Lymphoseek. The FDA indicated that the clinical data would be
supportive of a NDA submission for Lymphoseek.
NEOPROBE
CORPORATION
ADD
- - 2
In future
pre-NDA meetings, Neoprobe will continue discussions with the FDA reviewers
regarding the pre-clinical and chemistry, manufacturing and control quality data
modules that will be part of the NDA submission. Neoprobe will be discussing
elements of the statistical analysis plan that would support the NDA, including
the design of any prospective clinical evaluations to support the primary
indication, and to potentially expand the future indications for
Lymphoseek.
Neoprobe’s
President and CEO, David Bupp, Vice President, Pharmaceutical Research and
Clinical Development, Frederick Cope, Ph.D. and Vice President, Regulatory
Affairs and Quality Assurance, Rodger Brown, will discuss the NEO3-05 results
and FDA meeting results during a conference call scheduled for 8:30 AM EST,
Friday, March 12, 2010.
The
conference call can be accessed as follows:
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Time:
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Mar.
12, 2010
8:30
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Mar.
19, 2010
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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.