Following the FDA’s ‘safe to proceed’ letter for the 18F-ML-10 IND, NST will expand its neurovascular disorders and cancer clinical programs into the US. The first protocol already submitted to the FDA evaluates 18F-ML-10 in visualizing apoptosis and neurovascular damage in patients with relapsing-remitting multiple sclerosis, as well as the safety of administering 18F-ML-10. NST intends to submit additional protocols in the near term for evaluating 18F-ML-10 in detecting and monitoring tumor response to anticancer therapy.
ML-10 is said to be a member of the Aposense family of molecules, a novel class of small molecular probes that detect and accumulate within cells undergoing apoptosis from its early stages. The 18F-ML-10 is labeled with the radioisotope 18F for molecular imaging of programmed cell death in ‘real-time’ with positron emission tomography.
Yoram Ashery, CEO of NST, said: “Initial clinical data for our 18F-ML-10 compound for molecular imaging of apoptosis suggest that we may be able to deliver on the promise of personalized medicine by using real-time images of cell death to monitor disease activity and patient response to treatment.”