Pharma

Neoprobe gains regulatory clarity on colorectal cancer detection drug

Cancer diagnostics company Neoprobe (NYSE Amex:NEOP) said it had gained clarity around the chemistry and […]

Cancer diagnostics company Neoprobe (NYSE Amex:NEOP) said it had gained clarity around the chemistry and manufacturing of its investigational colorectal cancer detection drug after a meeting with European regulators.

Most significantly to Neoprobe, the meeting confirmed the company’s opportunity to develop a humanized antibody rather than a mouse-based antibody in its clinical development of RIGScan, a radiopharmaceutical targeting agent used to detect tumors left behind after colon cancer surgery, according to a statement from Dublin, Ohio-based Neoprobe.

The potential mouse-to-human shift regarding the antibody is important because Neoprobe says the humanized structure would better position the drug for regulatory approval, partnering, commercialization and enhanced intellectual property protection opportunities.

An antibody is a protein that can be produced by the body’s immune system when it detects harmful substances, called antigens. In RIGScan’s case, the antibody is the substance that allows the drug to bind to a patient’s cancer cells.

“The opportunity to move away from an antiquated mouse-based antibody to a state-of-the-art humanized form can potentially provide important return on our investment,” CEO Mark Pykett said in the statement.

Neoprobe’s meeting was with officials from the European Medicines Agency (EMA), a regulatory group roughly equivalent to the Food and Drug Administration in the U.S. Neoprobe conducted a similar meeting with FDA officials earlier this year, according to the statement.

Neoprobe says it must present detailed plans for clinical development to both the FDA and EMA to align, to the extent possible, the clinical studies required for approval of RIGScan.  The drug is likely several years away from approval.

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