Neoprobe, a developer of oncology surgical and diagnostic products, has completed a pre-IND meeting with the US Food and Drug Administration (FDA) on the development of RIGScan CR.
The RIGScan CR is a proprietary radiopharmaceutical used for the detection of colorectal cancer tumors.
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.
Neoprobe executive vice president and chief development officer Mark Pykett said the positive outcome of the meeting with FDA allows us to take an important step for Neoprobe’s pipeline development and corporate business strategy.
"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," Pykett said.