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news.Aposense, a molecular imaging and drug development company, has initiated a Phase II, multi-center study of its (18F)-ML-10 compound for molecular imaging of apoptosis at Memorial Sloan-Kettering Cancer Center, following approval by its institutional review board.
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This study aims to evaluate the safety and efficacy of (18F)-ML-10 in early assessment of response of metastatic brain tumors to high-dose, single-fraction radiotherapy (also known as stereotactic radiosurgery). Patient enrollment is scheduled to begin shortly, with target recruitment of 30 to 60 patients. Several other US cancer centers are also expected to participate.
The study will assess the safety and efficacy of imaging of apoptosis with (18F)-ML-10 to detect response to treatment of brain metastases, within several days after treatment. Apoptosis will be observed by mapping the uptake of (18F)-ML-10 within the tumor by using a positron emission tomography scan, to be performed prior to treatment and at two other points within one week after treatment.
According to the company, changes in the (18F)-ML-10 uptake will be compared with changes in tumor size two months after treatment according to MRI. The study endpoints include assessment of apoptotic changes occurring within days after treatment, and the accuracy of these changes in predicting treatment results.
Yoram Ashery, CEO of Aposense, said: Initiation of this Phase II study is a significant milestone for Aposense and we look forward to collaborating with the scientists and physicians at Memorial Sloan-Kettering.
This study marks the expansion of our (18F)-ML-10 program into an area with significant unmet need for real-time information on the biological effect of cancer therapy, and for potentially enabling individualized care for cancer patients using molecular imaging of apoptosis.