Novelos initiates enrollment in HOT Phase 1b trial for advanced solid tumors

Novelos Therapeutics, Inc. (OTCBB: NVLT), a pharmaceutical company developing novel drugs for treatment and diagnosis of cancer, today announced that it has enrolled the first patient in a U.S. multi-center Phase 1b dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound (131)I-CLR1404 (HOT) in cancer patients with advanced solid tumors.  Details of the trial design are available on www.clinicaltrials.gov ID: NCT01495663, or at www.novelos.com in the 'Clinical Trials' section.  Glenn Liu, M.D., University of Wisconsin Carbone Cancer Center, is the trial's principal investigator.

"Patients with advanced solid tumors need new, safer and more effective therapies," said Dr. Liu.  "Based on animal data and initial data from a Phase 1a dosimetry trial, HOT appears to deliver radiation directly and selectively to tumors and cancer stem cells."

"The data from this trial will be combined with calculation of effective doses for HOT based on quantitative positron emission tomography (PET) tumor imaging data using LIGHT, our small-molecule cancer-targeted PET imaging agent," said Harry Palmin, President and CEO of Novelos.  "Together, we believe this combination will enable us to commence HOT Phase 2 proof-of-concept trials in the first quarter of 2013 in advanced cancer patients with significant unmet medical need."