NVLT - Novelos Continues to Advance LIGHT Phase I/II Programs in Solid Tumors

By Grant Zeng, CFA

On October 25, 2012, Novelos Therapeutics (OTC Markets: NVLT) announced that the University of Wisconsin Carbone Cancer Center (UWCCC) has enrolled the first patient in a Phase I/II positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with additional nine solid tumor types, including triple negative breast, soft tissue sarcoma, colorectal, gastric, esophageal, prostate, ovarian, pancreatic and head & neck cancer.

Glenn Liu, M.D., Associate Professor of Medicine and Director of the Cancer Therapy Discovery and Development Program at the UWCCC, is the trial's principal investigator. Initial imaging results are expected in 1Q2013.

LIGHT is a small-molecule imaging agent that 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 shorter-lived radioisotope, iodine-124, a new PET imaging isotope. Chemically, LIGHT is 18-(p-[I-124]iodophenyl) octadecyl phosphocholine, identical to COLD except that the iodine is the radioactive isotope, I-124, which has a radiation half-life of 4 days.

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 tumors in 52 of 54 animal models of cancer, demonstrating evidence of broad-spectrum, cancer-selective uptake and retention.

Novelos is conducting Phase I/II clinical trials to evaluate LIGHT across multiple solid tumor types.

An investigator-sponsored Phase I/II trial of LIGHT as a PET imaging agent for lung cancer was initiated in December 2011 at the University of Wisconsin Carbone Cancer Center (UWCCC) and first patient was enrolled in February 2012. Dr. Anne M. Traynor at UWCCC is conducting the Phase I/II trial. Novelos provides funding for the trial and the data is shared with Novelos while the study progresses and at the conclusion of the study. Up to 12 patients will be enrolled across two dose levels (3 mCi and 5 mCi) in this Phase I/II trial. Novelos already reported positive initial data in September 2012. The trial will be completed in 2012.

Another investigator-sponsored Phase I/II trial of LIGHT as a PET imaging agent for brain cancer was initiated in December 2011 at UWCCC and first patient was enrolled on March 15, 2012. Dr. Lance Hall at the UWCCC is conducting the Phase I/II trial. This trial is being funded by an Institute for Clinical and Translational Research (ICTR) grant, whereas the data is shared with Novelos while the study progresses and at the conclusion of the study. Up to 20 patients will be enrolled at a 5 mCi dose. Novelos also reported positive initial data in September 2012. The trial will be completed in early 2013.

An investigator-sponsored Phase I/II trial of LIGHT as a PET imaging agent for metastatic brain cancer was initiated in January 2012 at UWCCC. This trial is being funded by a $1.2 million grant from the National Cancer Institute.

LIGHT has the potential to supplant the current “gold standard” agent, 18-fluoro-deoxyglucose (FDG), due to its superior cancer-specificity and more favorable logistics of clinical use.

We believe positive data would establish proof-of-concept for LIGHT as a PET imaging agent for this indication, and could advance partnering discussions.

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