The FDA has granted fast-track status to a Purdue University scientist’s optical imaging technology that may significantly improve outcomes for patients with pancreatic cancer.
Dr. Philip Low developed the OTL 38 molecule, which will move quickly to phase 3 trials in human cancer patients. The molecule, given to patients intravenously, attaches to receptors on cancer cells and glows, identifying the cells that should be surgically removed.
Low said that up to 40% of cancers recur at the original site of the surgery because surgeons might miss a microscopic cluster of 10 or 20 cells that cannot be detected during a normal procedure. OTL 38 illuminates even those tiny clusters.
“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,” Low said. “This technology gives them a significantly better chance to find and remove all the cancer from a patient.”
Fast-track status speeds the process of designing and implementing clinical trials and reduces waiting times for the review of results. The OTL 38 molecule was also granted orphan drug status, which is given to the maker of a drug that treats rare conditions or diseases and offers protection from competition for a certain period.
Low said that positive results from a phase 2 study of OTL 38 were important to gaining fast-track status. In that study, 96% of the tissue that was illuminated in patients was confirmed by pathology to be cancerous, and 98% of the malignant lesions identified by the surgeons fluoresced brightly because of their uptake of the fluorescent dye.
A phase 3 trial of OTL 38 in ovarian cancer is expected to begin by the end of the year. Low and his colleagues are working on earlier-stage studies of OTL 38 in cancers of the lungs, kidneys, brain, and other organs.
Low’s company, On Target Laboratories, is also developing a molecule that would minimize the amount of brain tissue that would have to be taken to remove cancer cells, and a dye that can reveal cancer cells buried beneath tissue that would otherwise likely be missed during surgeries.
Source: Purdue University; October 26, 2016.