Molecular Imaging Agent Gears Up for Multicenter Clinical Trials
August 13, 2008 – Ion Beam Applications (IBA) and NeuroSurvival Technologies Ltd. (NST) today announced the signing of a collaboration agreement for radio-labeling and distributing APOSENSE [18F]-ML-10, NST’s novel agent for molecular imaging of apoptosis, to sites participating in multicenter clinical trials of APOSENSE [18F]-ML-10.
Apoptosis is a genetically controlled process of cell death, associated with most medical disorders, in multiple clinical areas including oncology, neurology and cardiology. [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. 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 is a 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.
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 radio-labeling of APOSENSE compatible with commercial scale distribution. The companies further agreed to work together to supply the radio-labeled agent to multicenter clinical trial sites in the U.S. and to negotiate terms for commercial supply following FDA approval.
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.
For more information: www.iba-worldwide.com