The FDA has issued a ‘safe to proceed’ letter to NeuroSurvival Technologies (NST) for its investigational new drug (IND) application for [18F]-ML-10, a molecular imaging agent, to proceed with its U.S. phase I/II clinical trial.
The Petch-Tikva, Israel-based NST said its [18F]-ML-10 is a member of a family of molecules, a class of small molecular probes that detect and accumulate within cells undergoing apoptosis from its early stages. Apoptosis is a genetically-controlled process of cell death, associated with most medical disorders, in multiple clinical areas, including oncology, neurology and cardiology.
Upon recognizing apoptosis-specific changes on the cell membrane, Aposense molecules undergo a change enabling them to enter and accumulate within the dying cell from the early stages of the death process, while being excluded from viable or necrotic cells, the company said. NST also noted that its [18F]-ML-10 is labeled with the radioisotope 18F for molecular imaging of programmed cell death in real-time with PET.
The phase I/IIa took place in Europe and Israel. Following the FDA’s letter for the [18F]-ML-10 IND, NST said it will expand its clinical programs in neurovascular disorders and cancer into the United States. 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 added that it intends to submit additional protocols in the near term for evaluating [18F]-ML-10 in detecting and monitoring tumor response to anticancer therapy.