Novelos completes I-131-CLR1404 Phase 1b trial on advanced solid tumors

Novelos Therapeutics, Inc. (OTCQX: NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that it has successfully completed the first cohort in a U.S. multi-center Phase 1b dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in cancer patients with advanced solid tumors.  The first two-patient cohort was successfully dosed with approximately 20 mCi of HOT, triggering enrollment into the second cohort at approximately 40 mCi.  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.  Detailed trial results are expected to be presented at a scientific venue at a later date.

"Patients with advanced solid tumors need safer and more effective therapies," said Dr. Liu.  "Based on animal data, results from a completed Phase 1a dosimetry trial, and now initial data from this Phase 1b trial, HOT appears to deliver radiation directly and selectively to cancerous tumors.  Data from the first cohort indicates HOT was well-tolerated, without any grade 3 or 4 toxicities, enabling enrollment of the first patient in the second cohort.  HOT uptake in cancerous tumors persisted for at least 21 days.  One patient with advanced prostate cancer remains on trial at two months following treatment with HOT, while another patient with advanced colorectal cancer has completed the trial."

"We are pleased with HOT's safety profile and selective cancerous tumor uptake and retention in this first cohort at a dose of approximately 20 mCi," said Kim Hawkins, Vice President of Clinical Development of Novelos.  "We now look forward to evaluating HOT at approximately 40 mCi in cancer patients with advanced solid tumors, as per the trial protocol.  We also look forward to adding two additional clinical investigators to the trial, Joanne Mortimer, M.D., at the City of Hope and Michael Pishvaian, M.D., Ph.D., at Georgetown University."

"We intend to combine the data from this trial with calculation of effective doses for HOT based on quantitative positron emission tomography (PET) tumor imaging data using I-124-CLR1404 (LIGHT), our small-molecule cancer-targeted PET imaging agent," said Harry Palmin, President and CEO of Novelos.  "Together, we believe these data will enable us to commence HOT Phase 2 proof-of-concept trials in the first quarter of 2013 in cancer patients that have significant unmet medical need."