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Neoprobe Files Response to FDA Review Letter of RIGScana" Biologic License Application

^{Published on 2010-10-21 08:20:42 - Market Wire}
 

DUBLIN, Ohio--([ BUSINESS WIRE ])--Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has submitted a response letter to the U.S. Food and Drug Administration (FDA) regarding its RIGScan^a" technology Biologic License Application (BLA). The filing of the BLA response letter is the initial step in Neoprobea™s efforts to commercialize the RIGS^® technology designed to enhance the surgical treatment of solid tumor cancers. The review responsibility for the RIGS BLA was recently transferred from the Center for Biologics Evaluation and Research (CBER) to the Division of Medical Imaging Products in the Center for Drug Evaluation and Research (CDER) at FDA.

"The submission of the BLA response letter is the first of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology"

aThe submission of the BLA response letter is the first of several near-term activities that Neoprobe intends to complete with FDA to reactivate the development of the RIGS technology,a said Rodger Brown, Neoprobea™s Vice President of Regulatory Affairs and Quality Assurance. aWe intend to file a request for an Investigational New Drug (IND) for the biologic component of the RIGS technology. The IND request will be accompanied by a synopsis of the proposed Phase 3 RIGS technology clinical evaluation. Once FDA has assigned a new IND we will file the complete protocol for FDA evaluation under the provisions of a Special Protocol Assessment (SPA). A SPA review of the prospective protocol will provide a clear development pathway for RIGS in 2011.a

Neoprobe executives will discuss the development activities for both the RIGS and Lymphoseek^® product initiatives during the third quarter earnings conference call planned for the second week of November.

About Neoprobe Corporation

Neoprobe Corporation (OTCBB: NEOP) 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 neoprobe^® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek^® and RIGScan^a". Neoprobea™s subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobea™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 ].

About RIGScan^a"

Neoprobea™s RIGScana" is a tumor-specific targeting agent used to alert surgeons to the existence of cancerous tissue, undetectable by traditional diagnostic and intraoperative techniques. The RIGScan agent may enable more effective colorectal cancer surgeries leading to improved patient survival.

Neoprobe is focusing its current efforts for RIGScan on submitting an investigational new drug (IND) amendment to FDA, along with a related request for a special protocol assessment (SPA) for a Phase 3 study in colorectal cancer subjects. This effort follows the receipt of a favorable response from the European Medicines Agency (EMEA) on a similar protocol. Following harmonization of the U.S. and EU clinical and regulatory approaches for RIGScan, Neoprobe intends to reinvigorate its efforts to identify a development partner for the product.

Statements in this news release, which relate to other than strictly historical facts, such as statements about the Companya™s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Companya™s products are forward-looking statementsThe words abelieve,a aexpect,a aanticipate,a aestimate,a aproject,a 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 Companya™s 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 Companya™s 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.