Novelos Therapeutics Successfully Completes Second Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer-Targeted Molecular Radiotherapeutic

MADISON, Wis., Sept. 11, 2012 /PRNewswire/ -- 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 second 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 second two-patient cohort was successfully dosed with approximately 40 mCi of HOT, triggering enrollment into the third cohort at approximately 60 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., Associate Professor of Medicine and Director of the Cancer Therapy Discovery and Development (Phase I) Program at the 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.

"Data from this second cohort indicates that HOT was well-tolerated, without any dose-limiting or sub-dose-limiting toxicities, enabling enrollment of the third cohort as planned," said Dr. Liu.  "We continue to observe selective uptake of HOT in cancerous tumors where it persists for at least 21 days."

"We are pleased with HOT's safety profile and selective cancerous tumor uptake and retention in this second cohort at a dose of approximately 40 mCi," said Kim Hawkins, Vice President of Clinical Development of Novelos.  "We now look forward to evaluating HOT at approximately 60 mCi in cancer patients with advanced solid tumors, as per the trial protocol."

"We expect to begin HOT Phase 2 proof-of-concept trials in the third quarter of 2013 in cancer patients that have significant unmet medical need," said Harry Palmin, President and CEO of Novelos.  "We believe the data generated from the ongoing HOT Phase 1b trial combined with cancerous tumor imaging data from the ongoing I-124-CLR1404 (LIGHT) clinical trials will enable selection of indications for HOT Phase 2 trials and guide trial designs."

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