| |
IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Vice
President / CFO
614
822 2330
|
October
30, 2007
Tim
Ryan,
The
Trout Group
646
378 2924
|
NEOPROBE
COMPLETES FDA MEETING REGARDING LYMPHOSEEK®
Phase
2 Results and Phase 3 Protocols Reviewed
DUBLIN,
OHIO - October 30, 2007 - Neoprobe Corporation (OTCBB: NEOP), a diversified
developer of innovative oncology and cardiovascular surgical and diagnostic
products, today announced that they held an end of Phase 2 meeting with U.S.
Food and Drug Administration (FDA) to review the conduct of a successfully
completed multicenter Phase 2 study of Lymphoseek®. In addition, Neoprobe and
FDA reviewed proposed protocols for Phase 3 clinical studies of Lymphoseek.
At
the conclusion of the discussion, Neoprobe and FDA were in concurrence regarding
the design of the Phase 3 studies.
David
Bupp, President and CEO, said, “Meeting with FDA to review our completed
clinical and development activities for Lymphoseek was an important corporate
milestone. The Phase 3 trials as discussed with FDA will evaluate the
concordance of the targeting of lymph nodes with Lymphoseek as compared to
a
blue dye commonly used in lymphatic mapping procedures. Neoprobe needs to
respond to FDA’s comments regarding the Phase 3 protocols. We expect a response
to FDA comments will be filed shortly, along with the formal Phase 2 study
report. In the interim, activities are underway to initiate the Phase 3 studies
after appropriate final clearances from FDA and with the appropriate reviews
by
the investigational sites.”
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 neo2000®
line of
gamma detection systems that are widely used by cancer surgeons and is
commercializing the Quantix®
line of
blood flow measurement products developed by its subsidiary, Cardiosonix Ltd.
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-KSB and other Securities and
Exchange Commission filings. The Company undertakes no obligation to publicly
update or revise any forward-looking statements.