On January 13, 2022 On Target Laboratories, Inc., a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, reported the completion of the Phase 3, randomized, multi-center, single dose, open-label ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) Trial, which investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected cancer in the lung (Press release, On Target Laboratories, JAN 13, 2022, View Source [SID1234605473]).
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The study (NCT04241315) assessed the efficacy of CYTALUX and near-infrared imaging (NIR) to intraoperatively identify pulmonary nodules and detect positive margins. It also evaluated the safety and tolerability of single intravenous doses of CYTALUX. The trial successfully achieved its primary endpoint and full results will be shared in the future.
"Lung cancer is the number one cancer killer of men and women globally," said Inderpal (Netu) Sarkaria, MD, MBA, FACS Associate Professor of Cardiothoracic Surgery and Chair in Minimally Invasive Thoracic Surgery and Director of Thoracic Robotic Surgery at UPMC and ELUCIDATE trial investigator. "There is opportunity for emerging technologies to enhance our ability to find and remove cancer during surgery to improve the lives of lung cancer patients."
CYTALUX was approved by FDA on November 29, 2021 for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. CYTALUX is the first targeted molecular imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal. CYTALUX, administered by standard IV prior to surgery, binds to folate receptors that are overexpressed in most epithelial ovarian cancersi and illuminates intraoperatively under near-infrared light.
"ELUCIDATE was completed ahead of schedule, which was a monumental achievement during a pandemic," said Chris Barys, President and Chief Executive Officer of On Target. "We are grateful to the trial patients, the Investigators and their teams who helped us move yet another step closer to bringing CYTALUX to more patients fighting cancer."
About Intraoperative Molecular Imaging
To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.