March 16, 2012 — Novelos Therapeutics Inc. announced that the University of Wisconsin Carbone Cancer Center, a medical oncology research institution, enrolled the first patient in a Phase 1-2 positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with primary or metastatic brain cancer. The trial is being funded by an Institute for Clinical and Translational Research (ICTR) grant with Lance Hall, M.D., as principal investigator.
"Despite recent advances in diagnostic and therapeutic techniques, prognosis of patients with many brain tumors, and particularly malignant gliomas, remains dismal. This reflects in part the diagnostic uncertainty in identifying infiltrative tumor growth of malignant gliomas which in turn affects subsequent treatment strategies," said Hall. "The goals of this study will be to validate uptake of LIGHT in human brain tumors, determine the optimal imaging parameters, and compare tumor volumes and diagnostic accuracy of PET and magnetic resonance imaging (MRI)."
"We are very pleased to be expanding our collaboration with the UW Carbone Cancer Center," said Harry Palmin, president and CEO of Novelos. "We look forward to obtaining initial LIGHT imaging data in the second quarter of 2012 in cancer patients with primary brain tumors and brain metastases. We believe positive data would establish proof-of-concept for LIGHT as a PET imaging agent for this indication, could advance our partnering discussions and could be used to calculate effective doses for Phase 2 clinical trials of I-131-CLR1404 (HOT). HOT is our chemically identical small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells and cancer stem cells."
LIGHT is a molecule imaging agent comprised of a small non-pharmacological quantity of CLR1404 (COLD, acting as a cancer-targeted delivery and retention vehicle) labeled with the short-lived radioisotope, iodine-124, a new PET imaging isotope. PET imaging used in conjunction with computed tomography (CT) scanning has now become the imaging method of choice in oncology. In studies to date, LIGHT selectively illuminated malignant tumors in 52 of 54 animal models of cancer, demonstrating broad-spectrum, cancer-selective uptake and retention. Investigator-sponsored Phase 1-2 trials of LIGHT as a PET imaging agent are ongoing. The trials include lung cancer, brain cancer and, starting in the second quarter of 2012, other solid tumors. These human trials, if successful, will serve two important purposes. First, they would provide proof-of-concept for LIGHT itself as a PET imaging agent with the potential to supplant the current "gold standard" agent, 18-fluoro-deoxyglucose (FDG), due to what we believe to be LIGHT's superior cancer-specificity and more favorable logistics of clinical use. Second, favorable results would accelerate clinical development of HOT by predicting efficacy and enabling calculation of efficacious doses of HOT for Phase 2 trials.