Exhibit 99.1
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IMMEDIATE RELEASE
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April 16, 2008 |
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CONTACTS: |
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Brent Larson,
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Tim Ryan, |
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Vice President / CFO
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The Trout Group |
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614 822 2330
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646 378 2924 |
NEOPROBE RECEIVES REGULATORY CLEARANCE FOR LYMPHOSEEK CLINICAL STUDY
Lymphoseek Phase 3 Breast Cancer & Melanoma Trial Enrollment Cleared
DUBLIN,
OHIO April 16, 2008 Neoprobe Corporation (OTCBB: NEOP), a diversified developer of
innovative oncology and cardiovascular surgical and diagnostic products, today announced that
Neoprobe has been informed by FDA of its agreement with the Companys plan to commence patient
enrollment in a Phase 3 multi-center clinical study to evaluate the safety and efficacy of
Lymphoseek®, a lymphatic tissue targeting agent being developed by the Company. The
agreement for the Company to commence enrollment follows FDAs review of Neoprobes responses to
information requested by FDA related to prior submissions by the Company regarding the chemistry,
manufacturing and control and prior clinical testing of Lymphoseek. Neoprobe intends to enroll
approximately two hundred (200) patients at up to twenty-five cancer treatment centers in the
United States and Europe under the amended Phase 3 clinical protocol. Lymphoseek is intended to be
used in biopsy procedures for the detection of lymph nodes in patients with breast cancer, melanoma
and other tumor types.
David Bupp, Neoprobes President, said, To date, the clinical and preclinical results that have
been completed demonstrate the benefits of Lymphoseek. We believe the safety and efficacy of
Lymphoseek will be further supported by the completion of Phase 3 multi-center studies. In
preparation for the initiation of the Phase 3 clinical studies, Neoprobe met with potential Phase 3
investigators at the Society of Surgical Oncology meeting in late March. We expect to begin patient
enrollment in the first Phase 3 clinical study shortly after the FDA-approved clinical protocol and
associated materials receive final clearance from review committees of the investigational sites.
The Company is also preparing for a second Phase 3 trial to involve less than 200 evaluable
patients with head and neck squamous cell carcinoma. The second Phase 3 study is proposed to be
conducted in patients undergoing full nodal dissection for the staging of head and neck squamous
cell carcinoma and is intended to validate Lymphoseek as a lymph node targeting agent for use in
Intraoperative Lymphatic Mapping procedures. The Company hopes to commence this second Phase 3
trial around mid-year.
Neoprobe also announced today in a separate news release that it has agreed to terms regarding $3
million of funding in the second tranche of investment in the Company by Platinum-Montaur Life
Sciences LLC.
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. Neoprobes subsidiary, Cira Biosciences, Inc., is also advancing a
patient-specific cellular therapy technology platform called ACT. Neoprobes 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 Companys plans and strategies, expectations for future financial performance,
new and existing products and technologies, anticipated clinical and regulatory pathways, and
markets for the Companys 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 Companys 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 Companys 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.