SUMMARY OF INVENTION
Human tissue specimen Poly (ADP-ribose) polymerase-1 (PARP1) is highly elevated in a number of cancers, including oral cancer. In preclinical studies, MSK investigators have utilized a PARP1-targeted small molecule imaging agent as a diagnostic tool to identify oral squamous cell carcinoma in mouse models, and as an intraoperative imaging tool to improve surgical removal of tumors.
It is believed that a PARP1-targeted fluorescent imaging agent (PARPi-FL) could be utilized in dental offices and other clinical settings to detect malignant growth in a patient’s oral cavity. A mouthwash containing this imaging agent could improve a dentist’s ability to identify suspicious lesions, since the agent would only accumulate in areas of elevated PARP1 and would be detectable using a macroscopic fluorescence imaging device. Use of this technology would also improve identification of tumor margins and residual tumor tissue during oral cancer surgery.
- As a point-of-care diagnostic, a PARPi-FL mouthwash could be readily utilized by dentists, who typically provide the first “line of defense” against oral cancer
- By enabling earlier tumor detection and improved surgical accuracy, this technology could extend patient survival
- With IRB approval already granted for a Phase 1/2 clinical trial, MSK expects to enroll the first patient in 3Q 2016
There are 45,000 cases of oral cancer and over 9,000 deaths in the U.S. from this disease each year. With a 55% increase in incidence and 18% increase in mortality during the past 10 years, there is a significant market opportunity for an accurate and easy-to-use diagnostic to screen for and detect oral cancer.
STAGE OF DEVELOPMENT
Preclinical; planned Phase 1/2 clinical trial expected to begin in 3Q16
PCT application PCT/US2016/026717 was filed in April, 2016
Thomas Reiner, PhD, Laboratory Head, Memorial Hospital Research Laboratories, Memorial Sloan Kettering