Neoprobe Establishes Corporate IND for RIGScan CR; Neoprobe Assumes Corporate Responsibility for Clinical Evaluation.

DUBLIN, Ohio -- Neoprobe Corporation (OTCBB:NEOP), a diversified developer of innovative oncology and cardiovascular surgical and diagnostic products, today announced that the U.S. Food and Drug Administration (FDA) has accepted its request to establish a corporate Investigational New Drug (IND) application for a modified chimeric (i.e., humanized) version of RIGScan(R) CR. With the establishment of a corporate IND, responsibility for the clinical and commercial development of this humanized version of RIGScan CR has been officially transferred from a physician-sponsored IND to Neoprobe. RIGScan CR is a proprietary radiolabeled cancer targeting agent that provides the surgeon with real-time information during surgery to locate tumor deposits in colorectal cancer patients that may not be detectable by conventional methods.

Previous RIGS(R) clinical trials sponsored by Neoprobe were conducted using a murine (i.e., mouse-DNA-based) version of the RIGScan CR antibody. Due to general concerns regarding the use of murine antibodies in human patients, humanized versions of the RIGScan CR antibody, from which the prominent parts of the mouse DNA chain have been removed, were developed following Neoprobe's earlier trials. Following these development activities, independent clinical investigators completed a Phase I clinical trial using a humanized version of RIGScan CR under a physician-sponsored IND. Sponsorship for that IND is now being transferred to Neoprobe so that development of this humanized version may move forward under our corporate sponsorship.

David C. Bupp, Neoprobe's President and CEO, said, "We believe moving forward with a humanized version of RIGScan CR will address a number of concerns raised by FDA and will ultimately result in a more producible, reliable and effective drug. The potential partners we are in active discussions with, along with our regulatory advisors and representatives from various regulatory agencies, have all indicated a strong preference for using a humanized antibody in further RIGScan development activities."

Dr. Richard Orahood, Neoprobe's Medical Director, said, "The official transfer of responsibility for the IND is an essential step in moving the development of RIGScan CR forward. Our next step will be to file an amendment to the IND within the next 60 days to update FDA on all RIGScan CR development activities to-date and provide them with a detailed clinical development plan to support commercialization for the drug. The amendment will include the final report for the Phase I trial that involved the humanized version of RIGScan CR, essential non-clinical data regarding the safety of the humanized version of the drug and provide FDA with a basis for bridging the differences between the murine and humanized versions of RIGScan CR. Neoprobe has access to quantities of both the murine and humanized antibodies to conduct the proposed comparability studies. The amendment will also include a design for a pivotal Phase III trial (including protocol design and investigators brochures) and address manufacturing plans related to the chemistry, manufacturing and controls (CMC) requirements of FDA."

Bupp continued, "We have continued to move the RIGS process forward and are excited to be within reach of a number of significant developmental milestones. The clinical development plan we have outlined, including a request for a special protocol assessment (SPA), involves important next steps to us, as well as to the potential development partners we are in discussions with, and should enable us to embark on a pivotal trial following the completion of a development partnership."

About Neoprobe

Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome. Neoprobe currently markets the neo2000(R) line of gamma detection systems that are widely used by cancer surgeons and is commercializing the Quantix(R) line of blood flow measurement products. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek(TM) and RIGScan(R) CR. Neoprobe's recently formed 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

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