Molecule That ‘Lit Up’ Ovarian Cancer Cells During Surgery Put on Fast Track by FDA

Molecule That ‘Lit Up’ Ovarian Cancer Cells During Surgery Put on Fast Track by FDA
Surgery is the primary treatment for a large number of solid cancers, but the disease often comes back because surgeons miss tiny clusters of cells not seen during the procedure or in pre-operative images. Now, the U.S. Food and Drug Administration has granted Fast Track status to a new molecule designed to "light up" cancer cells, so that surgeons can see tiny cancer clumps, or which lymph nodes are affected by tumor cells. If approved, OLT38 could significantly improve outcomes for ovarian and other cancer patients who undergo surgery as their primary care. "This has the potential to save lives because the surgeons will tell you that the only sure way to cure cancer is to cut it all out," Philip Low, Purdue's Ralph C. Corley distinguished professor of chemistry, director of the Purdue Institute for Drug Discovery, who developed that OTL38 molecule, said in a press release. "This technology gives them a significantly better chance to find and remove all the cancer from a patient." Nearly 40 percent of tumors come back after surgery because surgeons miss microscopic clusters of 10 or 20 cells that are not seen in pre-operative images or during surgery. OTL38 is a compound that links a folic acid molecule, specific to tumor cells, to a near-infrared dye. The dye is injected two hours before surgery, and is designed to bind to the diseased tissue. Fast Track status was supported by results of a Phase 2 trial of OTL38 in 48 ovarian cancer patients (NCT02317705), which showed that 96 percent of the illuminated tissue was cancerous, and 98 percent of the malignant lesions "lit up" with the molecule. "Those are remar
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