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Novelos Therapeutics Successfully Completes Second Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer-Targeted Molecular Radiotherapeutic
Date:9/11/2012

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."

About HOT
HOT is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that we believe has first-in-class potential.  HOT is comprised of a proprietary phospholipid ether analog (PLE), acting as a cancer-targeted delivery and retention vehicle, covalently labeled with iodine-131, a cytotoxic (cell-killing) radioisotope that is already in common use to treat thyroid and other cancer types.  The ongoing Phase 1b dose-escalation trial is aimed at determining the Maximum Tolerated Dose of HOT.  We expect to initiate HOT Phase 2 efficacy trials as a monotherapy for solid tumors with significant unmet medical need as soon as a starting dose is established, subject to additional funding.  We may determine such a dose based on an efficacy signal or an acceptable safety profile in the Phase 1b trial.  Selection of indications for Phase 2, as well as aspects of trial design, will be guided by ongoing PET imaging trials in cancer patients with I-124-CLR1404 (LIGHT), a chemically identical biomarker for HOT.  Preclinical experiments in more than a dozen in vivo (in animals) tumor models have demonstrated selective killing of cancer cells along with a benign safety profile.  In view of HOT's selective uptake and retention in a wide range of solid tumors and in cancer stem cells, its single-agent efficacy in animal models and its non-specific mechanism of cancer-killing (radiation), we are first developing HOT as a monotherapy for solid tumors with significant unmet medical need.

About Novelos Therapeutics, Inc.
We are a pharmaceutical company developing novel drugs for the treatment and diagnosis of can
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