Neoprobe reports positive feedback from FDA for RIGScan development

Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has completed a successful pre-IND meeting with the U.S. Food and Drug Administration (FDA) on the development of RIGScan^TM CR, the Company's proprietary radiopharmaceutical for the detection of colorectal cancer tumors. As a result of positive feedback from FDA, Neoprobe will now move forward with continued development of the RIGScan technology in 2011 and 2012.

"As an outcome of the pre-IND meeting, we have clarified the path to reinitiate RIGScan development and the requirements for resuming development activities and moving toward clinical trials," said Rodger Brown, Vice President, Regulatory Affairs and Quality Assurance of Neoprobe Corporation. "FDA's guidance has provided direction to enhance our manufacturing platform, including process improvements to increase manufacturing efficiency and the quality of the underlying biologic antibody. We can now begin to implement our manufacturing plans through 2011 as a first step to recommencing clinical study of the technology in 2012 and beyond."

The focus of Neoprobe's pre-IND meeting with FDA was to first define the basic chemistry, manufacturing and controls requirements needed to resume clinical efforts on RIGScan. FDA reviewed Neoprobe's comprehensive package, including key aspects of the clinical development plan, and provided clear direction to the Company on its going-forward clinical and manufacturing activities. The Company hopes to be back in subjects with clinical studies with RIGScan in 2012.

"The positive outcome of the meeting with FDA allows us to take an important step for Neoprobe's pipeline development and corporate business strategy," said Dr. Mark Pykett, Executive Vice President and Chief Development Officer of Neoprobe Corporation. "We look forward to working with FDA, and to gaining scientific guidance with the European authorities, on the specific clinical trial protocols and criteria as we move forward with development of RIGScan CR, a technology that we hope can help improve the diagnosis and care of colorectal cancer patients."

Source: Neoprobe Corporation