Exhibit 99.1
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IMMEDIATE RELEASE
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October 31, 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 POSITIVE RESPONSE TO EUROPEAN RIGS SUBMISSION
All Scientific Advice Questions Provided with Affirmative Answers
DUBLIN, OHIO October 31, 2008 Neoprobe Corporation (OTCBB: NEOP), a diversified developer of
innovative oncology and cardiovascular surgical and diagnostic products, today announced that the
centralized European Medicines Agency (EMEA) has provided positive formal responses to Neoprobes
scientific advice submission regarding RIGScan CR and the pathway to receive a marketing
authorization for the drug.
Neoprobe asked the EMEA to review its manufacturing and clinical development plan for RIGScan CR.
The EMEA concurred that Neoprobe could use updated and improved manufacturing processes to produce
the antibody that is used in RIGScan CR and would be able to use all previously produced drug
safety data derived from prior clinical studies to support a marketing authorization. The EMEA
reviewed and agreed to the design and adequacy of a Phase 3 clinical study to be conducted in 380
patients with diagnosed primary or metastatic/recurrent colorectal cancer. The Phase 3 study would
be a randomized trial with equal control and RIGScan CR treatment cohorts. The primary endpoint of
the study would be improved survival for the RIGScan CR treated patients as compared to the control
arm.
Improved survival for the RIGScan CR treated patients was demonstrated in a retrospective survival
analysis of patients in a prior RIGScan CR clinical study (NEO2-14) that was accepted by the EMEA.
In addition, the EMEA agreed to the clinical need for a product like RIGScan CR to improve the
treatment of patients with colorectal cancer. Finally, the EMEA provided Neoprobe the opportunity
to request a conditional marketing authorization (CMA) after completion of the initial antibody
production or prospective clinical activities. The opportunity for granting a CMA will be dependent
upon the review of the supportive manufacturing and/or clinical information and there can be no
assurance that a CMA request would receive a favorable response.
David Bupp, Neoprobes President and CEO, said, We are excited by the response from the EMEA. The
scientific advice response provides a clear, achievable development pathway for RIGScan CR. The
response acknowledges that the technology meets a currently unmet medical need and has the
potential for improving the long term prognosis for both primary and recurrent colorectal patients.
The EMEA has suggested a mechanism for an early termination of the study if, as anticipated, early
improved outcomes are observed in the RIGScan treatment arm versus the control arm patients.
Mr. Bupp, and Vice President and CFO, Brent Larson, will provide an update on Lymphoseek and
RIGScan CR, as well as discuss the companys results for the third quarter of 2008 during a
conference call scheduled for 11:00 AM ET, Thursday, November 6, 2008.
NEOPROBE CORPORATION
ADD 2
The conference call can be accessed as follows:
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Conference Call Information |
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TO LISTEN TO A REPLAY: |
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Nov. 6, 2008 |
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Available until: |
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Nov. 13, 2008 |
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11:00 AM ET |
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Toll-free (U.S.) Dial in # : |
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877-344-7529 |
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International Dial in # : |
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412-317-0088 |
Toll-free (U.S.) Dial in # : |
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866-524-3160 |
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International Dial in # : |
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412-317-6760 |
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Replay passcode: |
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424978 |
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
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-K and other Securities and Exchange
Commission filings. The Company undertakes no obligation to publicly update or revise any
forward-looking statements.