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Novelos Therapeutics Announces Enrollment of First Patient in Solid Tumor Imaging Trial with I-124-CLR1404 (LIGHT) Cancer-targeted PET Imaging Agent at UW Carbone Cancer Center
Date:10/25/2012

MADISON, Wis., Oct. 25, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (OTCQX: NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that the University of Wisconsin Carbone Cancer Center (UWCCC), a leading oncology research institution, has enrolled the first patient in a Phase 1-2 positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with nine solid tumor types, including triple negative breast, soft tissue sarcoma, colorectal, gastric, esophageal, prostate, ovarian, pancreatic and head & neck cancer.  Details of the trial design are available at www.clinicaltrials.gov ID: NCT01662284, 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 UWCCC, is the trial's principal investigator.

"We are pleased to begin enrollment in this trial to evaluate LIGHT across multiple solid tumor types," said Dr. Liu.  "Oncologists are in need of better tools to diagnose patients more accurately and LIGHT has the potential to improve upon currently used standard approaches.  Accurate diagnosis of local, regional and distant metastatic spread is critical for optimal management and improved accuracy of staging may also spare patients the morbidity of unnecessary, non-curative surgical procedures."

"We are very pleased to be expanding our collaboration with the UW Carbone Cancer Center," said Harry Palmin, President and CEO of Novelos.  "Having demonstrated initial positive LIGHT imaging data in lung and brain cancer patients this year, we now look forward to obtaining initial LIGHT imaging data across nine other solid tumor indications starting in the first quarter of 2013.  We believe additional positive data will further establish proof-of-concept for LIGHT as a PET imaging agent in multiple cancer indications as well as guide selection of indications and trial designs for Phase 2 clinical trials with I-131-CLR1404 (HOT).  HOT is our chemically identical small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells and cancer stem cells."

About LIGHT
LIGHT is a small-molecule, broad-spectrum, cancer-targeted imaging agent that we believe has first-in-class potential for selective detection of tumors and metastases in a broad range of cancers.  LIGHT is comprised of a proprietary phospholipid ether analog (PLE), acting as a cancer-targeted delivery and retention vehicle, covalently labeled with iodine-124, a short-lived PET imaging radioisotope.  PET imaging used in conjunction with CT scanning has now become the imaging method of choice in oncology.  In studies to date, LIGHT selectively illuminated malignant tumors in 52 of 54 animal models of cancer, demonstrating broad-spectrum, cancer-selective uptake and retention.  Investigator-sponsored Phase 1-2 trials of LIGHT as a PET imaging agent are ongoing across 11 solid tumor indications.  Initial positive imaging results have been established in patients with lung and brain cancers.  These human trials, if successful, would likely provide proof-of-concept for LIGHT as a PET imaging agent with the potential to supplant the current "gold standard" agent, 18F-fluoro-deoxyglucose (FDG), due to what we believe to be LIGHT's superior cancer-specificity and more favorable logistics of clinical use.  As a chemically identical biomarker for HOT, we believe that LIGHT tumor uptake data could accelerate clinical development of HOT by guiding selection of indications for HOT Phase 2 trials and potentially be used in such trials to identify suitable patients and assess therapeutic efficacy.  For the same reason, and in view of the quantitative nature of PET imaging, we also believe that LIGHT imaging may be capable of estimating an efficacious dose of HOT in individual patients.

About the UW Carbone Cancer Center in Madison
The UWCCC is recognized throughout the nation as one of the leading innovators in cancer research, quality patient care and active community involvement. It is the only comprehensive cancer center, as designated by the National Cancer Institute, in Wisconsin. An integral part of the UW School of Medicine and Public Health, the UWCCC unites physicians and scientists who work together in translating discoveries from research laboratories into new treatments that benefit cancer patients.  To learn more about clinical studies and other initiatives, visit www.uwhealth.org/uw-carbone-cancer-center/for-researchers/uwccc/28373

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, broad-spectrum, 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, subject to additional funding, 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.  CLR1502 (GLOW2) is a preclinical, cancer-targeted, non-radioactive 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 www.novelos.com

INVESTOR CONTACTS
J. 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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SOURCE Novelos Therapeutics, Inc.
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