Contact Information: Contacts: David Carey Lazar Partners Ltd. 212-867-1768 Nitzi Avro +972-544-660-555
APOSENSE(R) [18F]-ML-10 for Molecular Imaging of Apoptosis to Proceed to Phase I/II Trials
U.S. Food & Drug Administration Issued a "Safe to Proceed" Letter for the Novel Agent for Molecular Imaging of Apoptosis (Programmed Cell Death)
| Source: NST NeuroSurvival Technologies
PETCH-TIKVA, ISRAEL--(Marketwire - 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® [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).