First Patient Treated in Pivotal Phase 3 Trial to Evaluate OTL38 in the Detection of Ovarian Cancer
Published: Apr 05, 2018
WEST LAFAYETTE, Ind., April 5, 2018 /PRNewswire/ -- On Target Laboratories, Inc., a privately held biotechnology company that is developing tumor-targeted fluorescent dyes to improve cancer surgery, announced today that the first patient was treated in a Phase 3 clinical trial of OTL38 in the detection of ovarian cancer.
The randomized, multi-center, single dose, open label, pivotal Phase 3 study in patients with ovarian cancer will assess the efficacy of OTL38 to identify additional ovarian cancer lesions not detectable by current means. The trial is expected to enroll 147 patients at six leading U.S. cancer sites. Top-line data from the trial are expected in 2019. For more information refer to www.clinicaltrials.gov, using the NCT identifier NCT03180307.
"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 Laboratories. "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."
"Being able to positively identify cancerous tissue is critical in the long term success of treatment," said Janos L. Tanyi, M.D., Ph.D., Assistant Professor of Obstetrics and Gynecology at the Perelman School of Medicine at the University of Pennsylvania, and 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."
OTL38, which is currently being evaluated in a Phase 3 clinical trial in ovarian cancer and a phase 2 clinical trial in lung cancer, is given to patients intravenously before surgery. In ovarian cancer surgery studies, OTL38 is being evaluated for its ability to help surgeons locate and remove hard-to-find cancerous lesions that are often widespread. Similarly, in clinical trials of OTL38 in lung cancer surgery, On Target Laboratories is evaluating whether OTL38 allows surgeons to better locate smaller nodules, synchronous lesions and positive margins.
About On Target Laboratories, Inc.
On Target Laboratories Inc., is in the business of discovering, developing and commercializing small molecules that, when conjugated with fluorescent dyes, target and illuminate specific cancerous cells and other diseased tissue. These conjugates can be used by doctors, including surgeons, worldwide to better diagnose and treat a wide range of diseases from cancer to inflammation-related disorders. OTL38 is currently under clinical development for use in ovarian and lung cancer surgery. For more information visit www.ontargetlaboratories.com.
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SOURCE On Target Laboratories