By Grant Zeng, CFA
On August 28, 2012, Novelos Therapeutics, Inc. (OTC Markets: NVLT) 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 FDA for GLOW2 in the second half of 2013 and begin clinical trials shortly thereafter, subject to additional funding.
GLOW2 is a small-molecule optical imaging agent that 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.
GLOW2 Selectively Target Tumor Cells
In preclinical models, mice without intact immune systems and inoculated with human HCT-116 (colorectal carcinoma) 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).
Market Potential of GLOW2 is Huge
According to the American Cancer Society, most cancer patients will have some type of surgery, and 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.
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. 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. Therefore, GLOWS could gain significant market share if approved by health authorities.
The GLOW2 program further expands Novelos’ pipeline, which illustrates the broad spectrum cancer therapy and imaging potential of the Company’s 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.
New Posters Demonstrate Efficacy of Clinical Programs
On Sept 7, Novelos 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. in the School of Medicine and Public Health at the University of Wisconsin, Madison 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. These three posters are:
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.
Physiologic organ 124I–NM404 uptake average (SUVav) in relationship with tumor uptake (SUVmax): LL (left lung), RL (right lung), LUL (left upper lobe), RLL sup seg (superior segment of the right upper lobe), R (right), L (left). In general, lesion SUVmax increases with time, while SUVav average of the different organs decreases with time, with the exception of the kidneys where SUVav is relatively stable over time.
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 to see 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.
The development of GLOW2 further expands the Company’s cancer-targeted imaging and therapy pipeline.
We believe Novelos’ platform technology has great potential for cancer imaging and therapy, which can be used in various cancer types. With all these progresses made in the past few months, we believe Novelos’ share price deserves an appreciation.
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