Ion Beam Applications (IBA) and Aposense have announced a collaboration agreement to commercialize Aposense's [18F]-ML-10, an agent for imaging apoptosis.
IBA, headquartered in Louvain-la-Neuve, Belgium, is a global provider of PET radiopharmaceuticals, while Aposense (formerly NST NeuroSurvival Technologies) of Petach-Tivka, Israel, develops agents targeting apoptosis (programmed cell death) for molecular imaging and therapy.
The agent [18F]-ML-10 is a small molecule radiotracer that allows the imaging of apoptosis, a fundamental biological process of controlled cell death, from the early stages of the death process. It should, according to the two companies, play a role in the early detection of disease, the monitoring of disease course, and the assessment of the affect of treatment or development of therapies. Specifically, [18F]-ML-10 could assist oncologists in evaluating tumor response to treatment earlier than conventional imaging modalities such as CT and MRI.
The long-term, global agreement includes the collaboration and joint funding by IBA and Aposense of phase III and subsequent clinical development of [18F]-ML-10, with IBA focusing on the PET imaging and nuclear medicine market, and Aposense marketing to the referring clinical specialist market. Aposense will manufacture the proprietary ML-10 precursor and IBA will18F-label and distribute the final drug product to sites through its global network of PET radiopharmacies.
According to the two companies, multi-center phase II clinical trials of [18F]-ML-10 are underway in a number of cancer centers in the U.S. and are expected to be completed in 2010, to be followed by phase III trials in 2011/2012 leading to final regulatory approval.