Novelos Therapeutics Successfully Completes Second Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT …

MADISON, Wis., Sept. 11, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (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 http://www.clinicaltrials.gov ID: NCT01495663, or at http://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."

About HOTHOT 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 cancer. Our cancer-targeted compounds are selectively taken up and retained in cancer cells, including cancer stem cells, versus normal cells. Thus, our therapeutic compounds appear to directly kill cancer cells while minimizing harm to normal cells. This offers the potential for a paradigm shift in cancer therapy by providing efficacy versus all three major drivers of mortality in cancer: primary tumors, metastases and stem cell-based relapse. I-124-CLR1404 (LIGHT) is a small-molecule cancer-targeted PET imaging agent. We believe LIGHT has first-in-class potential and Phase 1-2 clinical trials are ongoing across 11 solid tumor indications. I-131-CLR1404 (HOT) is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. We believe HOT also has first-in-class potential. HOT Phase 1b dose-escalation trial is ongoing and we expect HOT to enter Phase 2 trials in the third quarter of 2013 as a monotherapy for solid tumors with significant unmet medical need, subject to additional funding. CLR1502 (GLOW2) is a preclinical cancer-targeted optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging. Together, we believe our compounds are able to "find, treat and follow" cancer anywhere in the body in a novel, effective and highly selective way. For additional information please visit http://www.novelos.com

INVESTOR CONTACTSJ. Patrick Genn, Vice President of IR, Novelos Therapeutics, Inc., Madison, Wisc. & Boston, Mass., Ph: (858) 775-7456, Email: jpgenn@novelos.com

Anne Marie Fields, Senior Vice President, LHA, Ph: (212) 838-3777, Email: afields@lhai.com, @LHA_IR_PR

This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates.Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.

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Novelos Therapeutics Successfully Completes Second Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT ...