Exhibit 99.2
IMMEDIATE RELEASE February 24, 2005
CONTACTS:
Brent Larson, Tim Ryan,
Vice President / CFO The Trout Group
614 793 7500 212 477 9007
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NEOPROBE ESTABLISHES CORPORATE IND FOR LYMPHOSEEK
Neoprobe Assumes Corporate Responsibility for Clinical Evaluation
DUBLIN, OHIO -- February 24, 2005 -- Neoprobe Corporation (OTCBB: NEOP), a
diversified developer of innovative oncology and cardiovascular surgical and
diagnostic products, today announced that U.S. Food and Drug Administration
(FDA) has accepted its request to establish a corporate Investigational New Drug
(IND) application for Lymphoseek(TM). With the establishment of the corporate
IND, responsibility for the clinical and commercial development of Lymphoseek
has been officially transferred from the University of California, San Diego
(UCSD) to Neoprobe. Lymphoseek is intended to be used in biopsy procedures for
the detection of lymph nodes in a variety of tumor types including breast,
melanoma, prostate, gastric and colon cancers.
In connection with the transfer of responsibility for the Lymphoseek IND from
UCSD to Neoprobe, FDA has provided guidance suggesting Lymphoseek be evaluated
in a multi-center clinical study to confirm the findings observed by the UCSD
researchers. This initial multi-center trial would then be followed by a
confirmatory Phase III study using the final cGMP material. Neoprobe intends to
commence enrollment in the first of the two multi-institutional studies as soon
as the appropriate regulatory and institutional review board clearances are
received. These multi-center studies are planned to be conducted at some of the
leading cancer treatment institutions in the world. FDA guidelines also require
Neoprobe to complete some additional preclinical activities prior to the
initiation of the multi-center trials. Neoprobe has initiated this preclinical
work in parallel to its other development activities and intends to submit an
IND amendment prior to the initiation of the multi-center studies.
Dr. Richard Orahood, Neoprobe's Medical Director, said, "To date, the clinical
and preclinical results that have been completed demonstrate the benefits of
Lymphoseek. We believe the properties of Lymphoseek will be confirmed by the
patients to be involved in the multi-center studies."
David C. Bupp, Neoprobe's President and CEO, said,"The guidance we have received
during our discussions with FDA has resulted in positive modifications to our
clinical development plan and, to this point, has not significantly affected the
overall number of patients to be accrued or our originally anticipated timeline
for filing a New Drug Application (NDA) for Lymphoseek by mid-2006."
Bupp continued, "Neoprobe has selected Reliable Biopharmaceutical of St. Louis,
MO to produce the cGMP material and Reliable has already successfully completed
an initial demonstration run of bulk material. In addition, Neoprobe has
selected a well known clinical research organization, i3 Research, to manage and
oversee the multi-center trials to be initiated for Lymphoseek."
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About Neoprobe
Neoprobe develops and provides innovative surgical and diagnostic products that
enhance patient care by meeting the critical decision making needs of healthcare
professionals. Neoprobe currently markets the neo2000(R) line of gamma detection
systems that are widely used by cancer surgeons for intraoperative lymphatic
mapping. Neoprobe is also in the process of commercializing the Quantix(R) line
of blood flow measurement products developed by its subsidiary, Cardiosonix
Ltd., that are designed to be used by cardiovascular surgeons, neurosurgeons and
critical care physicians. In addition, Neoprobe holds significant interests in
the development of related biomedical systems and agents including
Lymphoseek(TM) and RIGScan(R) CR. Lymphoseek is an investigational drug being
developed as a lymphatic tracing agent in conjunction with the University of
California, San Diego. The RIGS(R) system is an investigational technology that
combines the Company's gamma detection device technology with a proprietary
disease-specific radiolabeled cancer targeting agent, and a patented surgical
method to get real-time information to locate tumor deposits that may not be
detectable by conventional methods. Before surgery, a cancer patient is injected
with one of the targeting agents, which circulates throughout the patient's body
and binds specifically to cancer cell antigens or receptors. Concentrations of
the targeting agent are then located during surgery by the company's
gamma-detection instrument, which emits an audible tone to direct the surgeon to
targeted tissue. The Company'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.
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 product, 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.