The IND is one of a family of molecular probes that detect and accumulate within cells undergoing apoptosis from its early stages. Upon recognizing apoptosis-specific changes on the cell membrane, the APOSENSE molecules enter and accumulate within the dying cell, while being excluded from viable or necrotic cells.
By labelling the [18F]-ML-10 molecule with the radioisotope 18F, it is possible to follow the process of cell death using PET imaging. NST CEO Yoram Ashery claims initial clinical data "suggest that we may be able to [use] real-time images of cell death to monitor disease activity and patient response to treatment".
Preclinical studies with [18F]-ML-10 and other APOSENSE compounds show selective uptake in apoptotic cells in a variety of disease models, including solid tumours undergoing radio- and chemotherapy, different ischaemic and inflammatory conditions, neurodegenerative disorders, atherosclerosis and acute myocardial infarction.
Following the FDA approval for further research on [18F]-ML-10, NST plans to expand its clinical programmes in neurovascular disorders and cancer 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 the imaging agent. In the near term, NST intends to submit additional protocols to evaluate [18F]-ML-10 in detecting and monitoring tumour response to anticancer therapy.