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NST NeuroSurvival Technologies today announced that the U.S. Food and Drug Administration (FDA) issued a "safe to proceed" letter for the company's APOSENSE(R) [18F]-ML-10 Investigational New Drug Application (IND)
PETCH-TIKVA, ISRAEL | JulY 23, 2008 | NST NeuroSurvival Technologies Ltd. (NST), a clinical phase company developing molecular imaging agents and drugs that identify and target cells undergoing apoptosis (programmed cell death), today announced that the U.S. Food and Drug Administration (FDA) issued a "safe to proceed" letter for the company's APOSENSE(R) [18F]-ML-10 Investigational New Drug Application (IND).
[18F]-ML-10 is 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. 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 [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, [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.
About APOSENSE Technology
APOSENSE is a proprietary, novel class of rationally-designed, small molecules that selectively identify and accumulate within apoptotic (dying) cells in vivo. Apoptosis (programmed cell death) plays a role in many diseases across numerous clinical areas, including oncology, neurology and cardiology. Molecular imaging with APOSENSE enables real-time visualization of the biological activity of disease, its onset, change in course and response to therapy, and to personalize treatment for the individual patient. Therapeutic applications of APOSENSE technology in pre-clinical development include anticancer therapy which uses apoptotic cells in tumors as targets for specific delivery of cytotoxic compounds into the tumor. APOSENSE technology was developed by NST NeuroSurvival Technologies, a clinical stage molecular imaging and drug development company, focused on introducing novel imaging and therapeutic agents based on targeting of cells undergoing apoptosis. For additional information, visit www.nst.co.il.
About Apoptosis
Apoptosis is a genetically-controlled program of cell death, inherent in any nucleated cell in the body and therefore often referred to also as "cell suicide." Upon activation, the apoptotic program executes a well-characterized sequence of events by which the cell undergoes fragmentation and elimination by macrophages, without damaging the surrounding tissue. Apoptosis is a universal process of cell death and it plays a role in most medical disorders, making it one of the important processes of cell biology. For example, apoptosis has important roles in oncology, both in the process of tumor growth, as well as in treatment with most therapies which aim to induce death in cancer cells. Targeting cells undergoing apoptosis, for imaging or delivering therapy, can therefore have broad clinical applications.
About Molecular Imaging
Molecular imaging is an emerging field which aims to visualize non-invasively biological processes in-vivo. The ability to image disease-related biological processes may allow physicians to detect disease early, characterize the disease better and to personalize treatment by real-time monitoring of therapeutic effect. Molecular imaging depends on special molecules (probes) that can selectively target these biological processes, while carrying an imaging moiety for visualization, such as 18F or other positron emitting radio-isotopes that can be visualized by positron emission tomography (PET).
SOURCE: NST NeuroSurvival Technologies Ltd. |
