APOSENSE(R) [18F]-ML-10 to Be Radiolabeled By IBA for Multi-Center Clinical Trials
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(R) [18F]-ML-10, NST’s novel agent for molecular imaging of apoptosis, to sites participating in multi-center clinical trials of APOSENSE(R) [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(R) 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.
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.
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).
Contact IBA Paul-Emmanuel Goethals Director, Corporate Business Development & Investor Relations Tél.: +32 10 47 58 16 Email Contact APOSENSE / NST David Carey Lazar Partners Tel: +646-239-6231 Email Contact
SOURCE: NeuroSurvival Technologies Ltd