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Novelos Therapeutics Successfully Completes First Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer-Targeted Molecular Radiotherapeutic
Date:5/15/2012

MADISON, Wis., May 15, 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 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
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SOURCE Novelos Therapeutics, Inc.
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