MADISON, Wis., Sept. 7, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (OTCQX: NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that three clinical imaging posters based on research conducted by Lance Hall, M.D., Anne M. Traynor, M.D., Glenn Liu, M.D., Jamey Weichert, Ph.D. and their colleagues are being presented at the World Molecular Imaging Congress taking place September 5-8, 2012 in Dublin, Ireland. These presentations describe initial findings in advanced cancer patients that demonstrate selective and prolonged uptake of Novelos' PET imaging and therapeutic compounds in a range of tumor types. Dr. Hall is Assistant Professor of Radiology, Dr. Traynor is Associate Professor of Medicine, Dr. Liu is Associate Professor of Medicine and Dr. Weichert is Associate Professor of Radiology, all in the School of Medicine and Public Health at the University of Wisconsin, Madison and all are members of the UW Carbone Cancer Center. Dr. Weichert is also the Chief Scientific Officer of Novelos and the founder of Novelos' technology.
"We are consistently seeing cancer-selective tumor uptake and prolonged retention across multiple tumor types with I-124-CLR1404 (LIGHT) and I-131-CLR1404 (HOT)," said Dr. Hall. "LIGHT has potential as a stand-alone PET imaging agent for improved detection and management of patients with cancer. Additionally, LIGHT may serve as an ideal, chemically identical biomarker for HOT, which itself holds promise as a therapeutic agent, exploiting this novel targeting and retention mechanism. Together, LIGHT and HOT form a unique diapeutic approach to cancer detection and treatment."
The posters are available at www.novelos.com/technology-ip/posters-publications/
First in Human Use of I-124-CLR1404 PET/CT in Primary and Metastatic Brain Tumors
Dr. Hall and his colleagues are presenting clinical data showing that LIGHT PET/CT successfully imaged brain metastases and gliomas in humans. In doing so, the agent demonstrated a high degree of uptake and prolonged retention in tumors with no significant background uptake in normal brain tissue.
Relative Biodistribution and Tumor Uptake of I-124-CLR1404 in Humans with Non-Small Cell Lung Cancer
The second presentation by Dr. Hall and his colleagues reports clinical data demonstrating malignant tumor uptake of LIGHT with prolonged retention and an increasing tumor-to-background ratio in advanced non-small cell lung cancer patients. It also shows that the relative normal organ biodistribution of LIGHT is reproducible between patients.
Relative Biodistribution and Tumor Uptake of I-131-CLR1404 in Human Subjects with Advanced Colon Cancer
Dr. Hall and colleagues' third presentation indicates that pre-therapy planar imaging with a low dose of HOT can be used to determine its biodistribution prior to a therapeutic treatment dose of HOT. SPECT/CT imaging, following a higher dose of HOT, successfully demonstrated selective tumor accumulation and prolonged retention in two patients with treatment-resistant metastatic colon cancer.
"We are very pleased with the initial positive LIGHT imaging data in lung and brain cancer patients, as well as the selective cancerous tumor uptake and prolonged retention of HOT in advanced colon cancer patients," said Harry Palmin, President and CEO of Novelos. "Later this month we expect to enroll the first patient in a Phase 1-2 imaging trial of LIGHT in patients with nine other solid tumor types, as well as complete the second cohort in a U.S. multi-center Phase 1b dose-escalation trial of HOT."
LIGHT is a small-molecule 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. Also, tumor uptake data would likely accelerate clinical development of HOT by predicting efficacy and enabling calculation of efficacious doses of HOT for Phase 2 trials.
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 and/or upon calculating it from ongoing PET imaging trials in cancer patients with LIGHT (since PET imaging is quantitative, enabling determination of tumor radiation exposure at a given dose level). Preclinical experiments in vitro (in cell culture) and in more than a dozen in vivo (in animals) 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 www.novelos.com.
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.
J. Patrick Genn, Vice President of IR, Novelos Therapeutics, Inc., Madison, Wisc. & Boston, Mass., Ph: (858) 775-7456, Email: firstname.lastname@example.org
Anne Marie Fields, Senior Vice President, LHA, Ph: (212) 838-3777, Email: email@example.com, @LHA_IR_PR
SOURCE Novelos Therapeutics, Inc.