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IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Vice
President / CFO
614
822 2330
|
March
19, 2009
Tim
Ryan,
The
Shoreham Group
646
342 6199
|
NEOPROBE’S
PHASE 3 LYMPHOSEEK STUDY ACHIEVES POSITIVE RESULTS
Objective
Reached in Clinical Study of Patients with Breast Cancer or
Melanoma
DUBLIN,
OHIO – March 19, 2009 -- Neoprobe Corporation (OTCBB: NEOP), a diversified
developer of innovative oncology and cardiovascular surgical and diagnostic
products, today announced that a multicenter Phase 3 study of Lymphoseek® has
reached the accrual of 203 lymph nodes, the study’s primary accrual objective.
The multi-center open label study has been conducted in patients with either
breast cancer or melanoma. Based upon a review of the preliminary data from the
study, the primary efficacy end-point of the study was achieved.
David
Bupp, Neoprobe’s President and CEO, said, “Neoprobe is pleased to announce this
successful accrual milestone in the first Phase 3 study of Lymphoseek (NEO3-05).
In the Phase 2 multi-center study of Lymphoseek, which was conducted in patients
with breast cancer or melanoma, an overall localization rate of 94% in lymph
nodes was achieved in those patients where both a patent blue dye and Lymphoseek
were used. A similar concordance rate of 94% was established by Neoprobe and FDA
as the primary efficacy objective for the Phase 3 trial, NEO3-05. Based upon the
intraoperative worksheets and preliminary pathology reports, we believe that the
primary efficacy end-point of NEO3-05 has been achieved and no incidents related
to drug safety have been reported in the Lymphoseek studies. Upon completion of
a full analysis of the Phase 3 data, we will provide a complete update on the
study results after all clinical data has been reviewed by our internal clinical
team and external consultants. We expect full data will be available in the
2nd
quarter of 2009. We intend to hold a conference call to discuss the
full trial results when the study reviews have been completed.”
Lymphoseek
is a proprietary radioactive tracing agent being developed for use in connection
with gamma detection devices in a surgical procedure known as Intraoperative
Lymphatic Mapping. A
Phase 3 multi-center clinical trial for Lymphoseek in patients with breast
cancer or melanoma is concluding and a protocol for a second Phase 3 clinical
study to evaluate the efficacy of Lymphoseek as a sentinel lymph node tracing
agent in patients with head and neck squamous cell carcinoma has been submitted
to the U.S. Food and Drug Administration and the European Medicines
Agency.
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
NEOPROBE
CORPORATION
ADD
- - 2
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-KSB and other Securities and Exchange Commission filings. The
Company undertakes no obligation to publicly update or revise any
forward-looking statements.