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FDA grants fast track designation to tumor-detecting intraoperative imaging agent
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The FDA granted fast track designation to ONM-100, an IV intraoperative imaging agent used to detect tumors and metastatic lymph nodes during surgery of solid cancers.
Researchers also may now proceed with a phase 2 clinical trial of ONM-100 (OncoNano). A phase 1 clinical trial is currently underway in the Netherlands.
“These two positive responses from the FDA reflect the progress that we have made on ONM-100,” Kathy Rath, vice president of regulatory affairs at OncoNano Medicine, said in a press release. “The fast track designation will allow us to have an ongoing, open dialogue with the FDA with the goal to make this important technology available to surgeons and their patients at the earliest possible time.”
ONM-100 — which is delivered to the tumor and fluoresces in the acidic tumor microenvironment — allows surgeons to visualize the tumor during surgery using existing infrared-based surgical cameras. The agent is part of the manufacturer’s library of micelles that respond to pH variability, which also are being used to develop therapeutics, cancer nanovaccines and immunotherapies.
“We are excited for the opportunity to work closely with the FDA while developing this critical solution to the problems surgeons face every day,” Yalia Jayalakshmi, vice president of clinical development at OncoNano Medicine, said in the release. “With these responses and the emerging clinical data demonstrating the potential of the product in multiple types of solid tumors, including breast, head and neck, esophageal and colorectal cancers, we are well positioned to advance ONM-100 into a phase 2 clinical study in 2019.”