Contact Information: Contact IBA Paul-Emmanuel Goethals Director, Corporate Business Development & Investor Relations Tél.: +32 10 47 58 16 APOSENSE / NST David Carey Lazar Partners Tel: +646-239-6231
APOSENSE(R) [18F]-ML-10 to Be Radiolabeled by IBA for Multi-Center Clinical Trials
Companies Announce Collaboration to Scale-Up APOSENSE [18F]-ML-10 Production for U.S. Clinical Trials and Commercial Use
| Source: NeuroSurvival Technologies Ltd
LOUVAIN-LA-NEUVE, BELGIUM and PETACH-TIKVA, ISRAEL--(Marketwire - August 13, 2008) - IBA (Ion
Beam Applications S.A.: Reuters IBAB.BR and Bloomberg IBAB.BB) the leading
global provider of PET radiopharmaceuticals, and NST (NeuroSurvival
Technologies Ltd.) the leading developer of agents targeting apoptosis
(programmed cell death) for molecular imaging and therapy, today announced
the signing of a collaboration agreement for radiolabeling and distributing
APOSENSE® [18F]-ML-10, NST's novel agent for molecular imaging of
apoptosis, to sites participating in multi-center clinical trials of
APOSENSE® [18F]-ML-10.
[18F]-ML-10 is a member of the APOSENSE family of molecules, a novel class
of rationally-designed, small molecular probes that selectively target 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. APOSENSE [18F]-ML-10 is labeled with the
radioisotope [18F], the most commonly used isotope for molecular imaging
with positron emission tomography (PET).
IBA Molecular (a business unit of IBA) is the leading global provider of
PET radio-pharmaceuticals, utilizing a global network of radio-pharmacies
for labeling and distribution of [18F] labeled agents, including worldwide
more than 37 cyclotron-equipped manufacturing sites.
"This collaboration is an important step in building the infrastructure
necessary to enable the use of APOSENSE® in our upcoming clinical trials,
and ultimately, commercialization in the U.S.," said Yoram Ashery, CEO of
NST. "We are excited to partner with IBA, a world leader in the production
of radio-isotopes for imaging and therapeutics, and about our shared vision
of the potential role that APOSENSE can play in helping to improve patient
care in multiple disease areas."
"This agreement is an important milestone in the expansion of our leading
position in the field of radiopharmaceutical products. After the
announcement in May with Wilex AG, this is the second agreement for a novel
agent in the field of PET radiopharmaceuticals and it confirms our strategy
of offering technology, materials and services to medical imaging centers
from a single source. We very much look forward to our enhanced
cooperation," said Pierre Mottet, Chief Executive Officer of IBA.
Under the terms of the agreement, IBA and NST will initially collaborate on
developing and optimizing the radio-chemistry and processes necessary for
GMP-grade radiolabeling of APOSENSE compatible with commercial scale
distribution. The companies further agreed to work together to supply the
radio-labeled agent to multi-center clinical trial sites in the United
States and to negotiate terms for commercial supply following FDA approval.
Financial details were not disclosed.
APOSENSE has been studied in two European clinical trials including a phase
I study in healthy volunteers to determine safety, dosimetry and
biodistribution, and preliminary efficacy in patients with cerebral
ischemic stroke. It is currently being evaluated in a phase IIa study in
Israel for early detection of response of metastatic brain tumor to
radiotherapy. NST was recently granted a "safe to proceed" letter by the
U.S. Food & Drug Administration for its APOSENSE investigational new drug
(IND) application. NST is preparing to expand its clinical programs into
the U.S., focusing on detecting and monitoring neurovascular disorders and
response to anti-cancer therapy.
About IBA
IBA delivers solutions of exceptional precision in the fields of cancer
diagnosis and therapy. The company also provides sterilization and
ionization solutions to improve the hygiene and safety of everyday life.
IBA is listed on the pan-European stock exchange EURONEXT and belongs to
the BelMid index. IBA's leading role in the field of Molecular Imaging
continues to grow through the constant innovation its technology is built
upon, as well as through its worldwide radiopharmaceuticals distribution
network. With an ever-increasing number of sites in North America, Europe
and Asia, IBA continues to make radiopharmaceuticals, today mostly FDG,
more accessible to hospitals and imaging centers across the world. Website:
http://www.iba-worldwide.com.
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 more information, visit
http://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 to detect disease early,
characterize it better and to personalize treatment by real-time monitoring
of its 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).