IMMEDIATE RELEASE OCTOBER 11, 2004
CONTACTS:
DAVID BUPP, TIM RYAN,
PRESIDENT / CEO THE TROUT GROUP
614 793 7500 212 477 9007
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NEOPROBE PROVIDES REGULATORY UPDATE ON RIGS AND LYMPHOSEEK
COMPANY RECEIVES FDA RESPONSE TO RIGS PROTOCOL
DUBLIN, OHIO - October 11, 2004 -- Neoprobe Corporation (OTCBB: NEOP), a
diversified developer of innovative oncology and cardiovascular surgical and
diagnostic products, today provided an update on the regulatory status of its
two oncology product clinical development programs. The two program initiatives
involve the radiopharmaceutical products RIGScan(R) CR and Lymphoseek(TM).
RIGScan CR is a radiolabeled tumor specific antibody targeting colorectal cancer
that is designed to provide treatment information to cancer surgeons thereby
improving patient diagnosis and clinical outcomes. Lymphoseek is a radiolabeled
tracing agent that is engineered to localize lymphatic tissue in the lymphatic
pathway draining from the primary site of malignant tumors thereby potentially
improving the staging of breast and other cancers while reducing the extent of
surgery in many patients.
Neoprobe reported that it has received a formal response from the United States
Food and Drug Administration (FDA) to a Phase III protocol design proposal for
RIGScan CR that the Company submitted to FDA in late June. The FDA's response
letter outlines FDA's guidance for the clinical objectives that are to be
achieved by the Phase III study. The response indicates that FDA would be
receptive to a clinical trial design that would incorporate both near-term
disease progression and long-term survival prognostic end-points. Further, the
response provides Neoprobe with guidance for the development of the clinical
data sheets and investigator training programs for the conduct of the Phase III
study in primary colorectal patients as well as for the further development of
the study design. Neoprobe intends to request a meeting with FDA to review the
Phase III study materials, to provide materials requested by FDA for diagnostic
endpoints of the study and to prepare for the initiation of the Phase III study
in 2005. In addition, Neoprobe intends to meet with the FDA to review the
company's biologic and radiolabeling production plans.
In addition, Neoprobe filed a formal request this week with FDA to establish a
corporate IND for Lymphoseek and to request a meeting with FDA to review a Phase
III protocol and drug production plan for Lymphoseek. The draft Phase III
protocol is designed to demonstrate that Lymphoseek is a reliable lymphatic
tissue targeting agent. If approved, Lymphoseek would be the first product to
receive regulatory clearance for marketing as a lymphatic tissue targeting
agent. The trial design outline to be reviewed with FDA is consistent with the
guidance provided by FDA and National Cancer Institute personnel at a meeting
late last year with the Interagency Council for Biomedical Oncology Products.
David Bupp, Neoprobe's President and CEO said, "We are very pleased to have
received this response from FDA concerning our clinical development program for
RIGScan CR and view their guidance as favorable toward the continuation of our
development efforts. Neoprobe is preparing for the potential initiation of the
new Phase III study of RIGScan CR during the first of half of 2005, although
timing will be dependent on a number of factors, including securing the
necessary financial resources. The study is designed to confirm the survival and
prognostic findings of the retrospective analysis of improved survival in
colorectal cancer patients that was reviewed with FDA in April. In addition, the
study as currently proposed is designed to demonstrate improved diagnostic
information for the cancer surgeon. Discussions with FDA related to their
responses could result in modifications to the final trial design. We are
working to reestablish biologic production and radiolabeling capabilities for
RIGScan CR to support a Phase III study. We are also continuing our discussions
with potential partners to participate with us in the development and
commercialization of RIGScan CR. Discussions to date have been positive but have
not resulted in a firm arrangement. However, we view the identification of a
partner as an important step in the ultimate completion of development and
commercialization activities for RIGScan CR.
In addition, the submission of the Lymphoseek IND meeting request with FDA
provides Neoprobe with the opportunity for the formal review of the Phase III
protocol for this product. We are preparing for the commencement of cGMP
production of the Lymphoseek drug compound. Pending the formal response from FDA
to the Phase III protocol design, we will be prepared to initiate patient
enrollment in the study late in the first quarter of next year."
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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,
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.