July 25, 2008 -- NeuroSurvival Technologies Ltd. (Petch-Tikva, Israel), says that the U.S. Food and Drug Administration has issued a "safe to proceed" letter for its APOSENSE [18F]-ML-10 Investigational New Drug application. The company, which goes by the initials NST, develops molecular imaging agents and drugs to identify and target cells undergoing apoptosis. Apoptosis is a genetically-controlled process of cell death, associated with medical disorders in such areas as oncology, neurology and cardiology.
Once APOSENSE molecular probes detect apoptosis-specific changes on the cell membrane, they undergo a change that lets them enter and accumulate within the dying cell from the early stages of the death process. The [18F]-ML-10 is labeled with the radioisotope 18F for molecular imaging of programmed cell death in "real-time" with positron emission tomography (PET).
"This is a major step for our company as we now can expand our APOSENSE clinical program into the largest healthcare market in the world," said Yoram Ashery, CEO of NST NeuroSurvival Technologies. "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."
Pre-clinical studies with [18F]-ML-10 and other APOSENSE compounds showed selective uptake in apoptotic cells in a variety of disease models, including solid tumors undergoing radio- and chemo-therapy, different ischemic and inflammatory conditions, neuro-degenerative disorders, atherosclerosis, acute myocardial infarction and others.
A phase I clinical study conducted in Europe evaluated the safety, dosimetry and biodistribution of [18F]-ML-10 in normal healthy volunteers, and its suitability for imaging of cell death in the region of the infarct in patients with acute ischemic cerebral stroke. In both parts of the study, the company says, [18F]-ML-10 manifested an excellent safety profile and efficacy in imaging cell death. A phase IIa study was recently initiated in Israel in patients with metastatic brain tumors, a serious complication found in up to 25% of patients with advanced cancer. The study evaluates [18F]-ML-10 in early assessment of response to radiotherapy, compared to MRI which typically can evaluate response only two months or longer after treatment has been completed.
Following the FDA's "safe-to-proceed" letter for the [18F]-ML-10 IND, NST will expand its clinical programs in neurovascular disorders and cancer into the U.S. 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.