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Neoprobe Corporation (NYSE Amex: NEOP), a diversified developer of innovative diagnostic products, today announced that it received positive scientific advice late last week from the European Medicines Agency (EMA) on the development of RIGScan
TM CR, the Company’s proprietary radiopharmaceutical for the detection of colorectal cancer.
In the EMA meeting, Neoprobe sought scientific guidance on the chemistry, manufacturing and controls (CMC) related to RIGScan and on non-clinical requirements needed to resume clinical development. EMA provided positive feedback on these development activities and on Neoprobe’s plan for manufacturing and non-clinical testing. Importantly, EMA confirmed the opportunity for Neoprobe to consider evaluating a humanized RIGScan antibody for clinical development and commercialization.
The meeting with the European regulatory body follows a successful pre-investigational new drug (IND) meeting with the Food and Drug Administration (FDA) earlier this year. Potential use of a humanized antibody form instead of a mouse-based antibody is an important, positive development enabling utility of an improved technology, state-of-the art manufacturing processes and a more clinically acceptable drug. The potential shift to a humanized structure would better position the product for regulatory approval, partnering, commercialization and enhanced intellectual property protection opportunities.
“Following review of our development package, EMA provided important guidance on our RIGScan development plan which allows us to maintain our current activities in re-starting manufacturing of the RIGScan antibody,” said Rodger Brown, Vice President, Regulatory Affairs and Quality Assurance of Neoprobe. “Positive guidance from both agencies enables us to begin harmonized efforts to reintroduce RIGScan back into the clinic. We are evaluating the overall implications on our clinical plans of the specific feedback received from these two agencies, but the guidance received to date from regulatory authorities is consistent with our objective of bringing the technology back into clinical development.”
The Company does not believe that the transition to a humanized antibody would delay the ongoing CMC process development activities underway since the FDA pre-IND meeting. Additionally, based on the discussion of clinical objectives for RIGScan with EMA, the Company does not envision that a change to the humanized antibody form will increase the anticipated overall number of patients required for registration. Detailed plans for clinical development must be presented to and discussed with both FDA and EMA to align, to the extent possible, the clinical studies required for approval.