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Novelos doses three patients in phase 1/2 PET imaging trial for metastatic brain cancer

Madison, Wisconsin
Thursday, June 21, 2012, 17:00 Hrs  [IST]

Novelos Therapeutics, Inc., a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, has successfully dosed three patients 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 three glioma patients were dosed with LIGHT at 5 mCi. Lance Hall, MD, is the trial’s principal investigator. This trial is being funded by the University of Wisconsin Carbone Cancer Centre (UWCCC) and the Institute for Clinical and Translational Research (ICTR). Detailed trial results are expected to be presented at a scientific venue at a later date.

“Despite recent advances in diagnostic and therapeutic techniques, prognosis of patients with many brain tumours, and particularly malignant gliomas, remains dismal. This reflects in part the diagnostic uncertainty in identifying infiltrative tumour growth of malignant gliomas which in turn affects subsequent treatment strategies,” said Dr. Hall. “The preliminary results from these three glioma patients are very encouraging. We see strong and sustained uptake of LIGHT in cancerous tumors against very low background and have not observed any adverse safety signals. Interestingly, LIGHT’s cancerous tumor to normal tissue uptake ratio exceeded 30:1 in one tumor, which compares favorably with PET agents that are generally considered good tumor biomarkers if tumor to normal tissue uptake ratios are in the range of 3:1 and 5:1.”

“Having observed well-tolerated cancer-specific uptake with LIGHT at 5 mCi in three glioma patients, we look forward to evaluating more patients at this dose level in this indication,” said Kim Hawkins, Vice President of Clinical Development of Novelos.

“We are very pleased by both the positive initial LIGHT imaging data in brain cancer patients obtained to date, and our continuing collaboration with the UWCCC,” said Harry Palmin, President and CEO of Novelos. “We believe these results begin to establish proof-of-concept for LIGHT as a PET imaging agent for brain cancer, and could be used to calculate effective doses for Phase 2 clinical trials of I-131-CLR1404 (HOT) in this indication. 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 small molecule imaging agent that we believe has first-in-class potential for selective detection of tumors and metastases in a broad range of cancers. LIGHT is 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 CT scanning has now become the imaging method of choice in oncology. In studies to date, LIGHT selectively illuminated malignant tumours in 52 of 54 animal models of cancer, demonstrating broad-spectrum, cancer-selective uptake and retention. Investigator-sponsored phase I-II trials of LIGHT as a PET imaging agent are ongoing. The trials include lung cancer, brain cancer and, starting in the third quarter of 2012, other solid tumours. These human trials, if successful, would likely provide proof-of-concept for LIGHT as a PET imaging agent with the potential to supplant the current “gold standard” agent, 18F-fluoro-deoxyglucose (FDG), due to what we believe to be LIGHT’s superior cancer-specificity and more favorable logistics of clinical use. Also, tumour uptake data would likely accelerate clinical development of HOT by predicting efficacy and enabling calculation of efficacious doses of HOT for phase II trials.

The UWCCC is recognized throughout the nation as one of the leading innovators in cancer research, quality patient care and active community involvement. It is the only comprehensive cancer centre, as designated by the National Cancer Institute, in Wisconsin.


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