A Phase 3 clinical trial testing a special dye that “lights up” ovarian tumor tissue during surgery has treated its first participant, On Target Laboratories announced.
The dye, called OTL38, is designed to make removal of cancerous tissue more complete and increase patients’ survival.
“Treating our first patient in a Phase 3 trial is a major milestone achievement for On Target Laboratories,” said Martin Low, CEO of On Target Laboratoriesin a press release. “Our work on this Phase 3 trial in ovarian cancer complements our ongoing work with OTL38 in lung cancer as well as the development of our other targeted dyes. On Target’s platform of targeted small molecules goes beyond lung and ovarian cancers and will eventually help surgeons precisely identify nearly all solid tumor cancers and a wide range of other diseases,” he said.
OTL38 is composed of a near-infrared dye attached to a folic acid-targeting molecule. Folic acid is highly produced by ovarian cancers, making it a suitable molecule for targeting tumor cells.
The dye is given intravenousy before surgery and within minutes the tumor tissue lights up. Using a near-infrared camera, surgeons will be better able to detect hard-to-find lesions, small cancer lesions, or affected lymph nodes that would be missed otherwise. This is expected to increase the success of the surgery and subsequently extend patients’ lives.
The pivotal Phase 3 study (NCT03180307) will assess the effectiveness of OTL38 to identify additional ovarian cancer lesions not detectable by current means. It is expected to include 147 women with ovarian cancer at six cancer sites in the U.S.
All patients will receive OTL38, but only a randomly chosen group will receive near-infrared imaging. The study’s primary goal is to determine if the approach increases the detection of folate receptor-positive lesions, compared to normal light or palpation (touching). Top-line data should be available in 2019.
“Being able to positively identify cancerous tissue is critical in the long-term success of treatment,” said Janos L. Tanyi, MD, PhD, principal investigator of the OTL38 trial. “A successful surgery that removes all of the ovarian tumor can significantly increase the overall survival.”
“With more than 20,000 new cases of ovarian cancer diagnosed every year in the U.S., new approaches that can improve patient outcomes are needed and we look forward to further evaluating the potential of OTL38 in this study,” added Tanyi, who is assistant professor of Obstetrics and Gynecology at the Perelman School of Medicine at the University of Pennsylvania.