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Novelos Therapeutics, Inc. (NVLT) Developing CLR1502 (GLOW2) Cancer-Targeted Optical Imaging Agent for Intraoperative Tumor Margin Illumination



8/30/2012 11:50:29 AM

MADISON, Wis., Aug. 28, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (OTCQX: NVLT), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that it is developing CLR1502 (GLOW2), a preclinical cancer-targeted optical imaging agent for intraoperative tumor margin illumination and non-invasive tumor imaging. GLOW2 is expected to facilitate and enable diagnostic, staging, debulking and curative cancer surgeries intraoperatively in real time. Novelos expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for GLOW2 in the second half of 2013 and begin clinical trials shortly thereafter.

"Current imaging modalities are extremely limited in their ability to define tumor margins, thus contributing to the unacceptably high rate of incomplete surgical removal of malignant tissue, which is associated with an increased risk of cancer recurrence," said Sharon Weber, M.D., Professor and Chief of Surgical Oncology, Vice Chair of Academic Affairs for General Surgery, University of Wisconsin Department of Surgery, and Director of Surgical Oncology, Carbone Cancer Center. "The potential for GLOW2 to provide surgeons with more accurate visualization of tumor margins during surgery could result in more complete and selective removal of tumors and significantly improve patient outcomes. I am excited to hear that Novelos is advancing the development of this product and look forward to the initiation of clinical trials, since the use of this technology could result in a profound positive impact on patient care."

"GLOW2 illustrates the broad spectrum cancer therapy and imaging potential of our proprietary phospholipid ether analog (PLE)-based delivery and retention vehicle which is also being used to selectively target cancer cells with a PET imaging agent (I-124-CLR1404, or LIGHT) and a molecular radiotherapeutic agent (I-131-CLR1404, or HOT) in ongoing clinical trials," said Jamey Weichert, Ph.D., Chief Scientific Officer and Technology Founder of Novelos. "We plan to continue to explore coupling other therapeutic and diagnostic moieties to our tumor-targeted PLE carriers."

About GLOW2

GLOW2 is a small-molecule optical imaging agent that we believe has first-in-class potential for intraoperative tumor margin illumination and non-invasive tumor imaging. GLOW2 is comprised of a proprietary phospholipid ether analog (PLE), acting as a cancer-targeted delivery and retention vehicle, covalently attached to a near-infrared (800nm) fluorophore. According to the American Cancer Society (2011), most cancer patients will have some type of surgery, and Cancer Facts and Figures indicated that approximately 1.3 million cancer patients were diagnosed with solid tumors in the U.S. alone in 2011. GLOW2 may facilitate and enable diagnostic, staging, debulking and curative cancer surgeries intraoperatively in real time by defining tumor margins and regional lymph node involvement, resulting in more accurate and successful tumor resectioning. In preclinical models, mice without intact immune systems and inoculated with human HCT-116 (colorectal carcinoma) and U87 (glioma) were injected with GLOW2 24 and 96 hours prior to imaging. In vivo optical imaging showed pronounced accumulation of GLOW2 in tumors versus non-target organs and tissues. In addition, non-invasive imaging with GLOW2 has been demonstrated in a variety of animal solid tumor models. Thus, GLOW2 may also have utility for non-invasive imaging of relatively superficial tumor types in man (e.g., melanoma, head & neck, colon, esophageal). We expect to submit an IND for GLOW2 in the second half of 2013 and begin clinical trials shortly thereafter, subject to additional funding.

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 in 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

INVESTOR CONTACTS


J. Patrick Genn, Vice President of IR

Anne Marie Fields, Senior Vice President

Novelos Therapeutics, Inc.

LHA

Ph: (858) 775-7456

Ph: (212) 838-3777

Email: jpgenn@novelos.com

Email: afields@lhai.com, @LHA_IR_PR



Novelos Therapeutics, Inc.

Madison, Wisc.

Boston, Mass.

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.

SOURCE Novelos Therapeutics, Inc.


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