Neoprobe submits IND amendment to FDA for RIGScan CR radiopharmaceutical

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced today that it has submitted an investigational new drug (IND) amendment to the United States Food and Drug Administration (FDA) which includes the design of a proposed Phase 3 clinical trial of Neoprobe’s RIGScan^® CR radiopharmaceutical. RIGScan CR is designed to identify and evaluate potentially tumor-associated tissue in patients with colon or rectal cancer. The IND amendment includes a Special Protocol Assessment (SPA) in accordance with the Prescription Drug User Fee Act of 1992 (PDUFA) and current regulatory guidelines, and will be registered on www.clincaltrials.gov following discussions with FDA regarding the SPA.

“The identification of tumor-associated tissue in cancer patients through the use of biomarkers is of increasing clinical interest and importance”

The Phase 3 clinical study as currently designed would be a randomized clinical study that would evaluate the ability of RIGScan CR to identify tumor-associated tissue in a group of patients as compared to a group of patients provided with traditional surgical care. The sample size of the proposed Phase 3 clinical study has been estimated at approximately 250 patients including both the RIGScan CR and traditional treatment groups. In addition to assessing the ability of RIGScan CR to identify tumor-associated tissue, the overall survival of the RIGScan CR treated patients will be compared to the patients treated with conventional treatment modalities.

“The identification of tumor-associated tissue in cancer patients through the use of biomarkers is of increasing clinical interest and importance,” said Dr. Fred Cope, Neoprobe’s Vice President, Pharmaceutical Research and Clinical Development. “RIGScan CR provided indications in earlier clinical studies that it could identify potentially tumor-associated tissue and that the removal of such tissue might improve patient outcomes. The objective of the proposed Phase 3 trial is to confirm those findings,” concluded Dr. Cope.

“The filing of the SPA request follows our successful discussions with the centralized European regulatory authorities (the EMEA) under their Scientific Advice process,” said David Bupp, Neoprobe’s President and CEO. “Dr. Cope and his team have completed an extensive scientific literature evaluation to support the design of the Phase 3 study and we initiated the biologic development activities to support the proposed Phase 3 study in 2009. The commencement of an evaluation of the Phase 3 study design under the SPA provisions is an important step in the development of RIGScan CR. The proposed trial design incorporates both diagnostic and therapeutic endpoints for the RIGS technology,” concluded Mr. Bupp.

RIGScan CR, when used with a commercially available hand-held gamma radiation detection probe, provides surgeons with real-time information used to locate tumor components not detectable by conventional methods, and assist in the more thorough removal of the potentially cancerous tissue. The RIGScan CR targeting agents are monoclonal antibodies labeled with a radioactive isotope that emits low energy gamma rays. Before surgery, a cancer patient is injected with the monoclonal antibody targeting agent, which circulates throughout the patient’s body and binds specifically to cancer cell components (cancer antigens). Concentrations of the targeting agent are then located during surgery by the gamma detection device, which emits an audible tone to direct the surgeon to tumor-involved tissue. Information on the clinical history and current development status of RIGScan CR can be obtained from Neoprobe’s previous press releases and filings with the U.S. Securities and Exchange Commission.