Most cancer patients will have some type of surgery. In fact, in 2011, approximately 1.3 million cancer patients were diagnosed with solid tumors in the U.S. alone. The need for surgery makes it imperative that doctors have an effective way to mark the outline of tumors. However, the present state of medical technology is unable to do so.
According to Dr. Sharon Weber, 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, “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.”
Novelos is a pharmaceutical company working to develop unique drugs for the treatment and diagnosis of cancer.
GLOW2 is expected to assist surgeons in removing tumors and cancerous tissue by marking them during surgery in real time. Novelos plans 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. Novelos intends to begin clinical trials shortly thereafter, subject to its ability to obtain funding.
Dr. Weber stated, “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,” added 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.”
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 humans such as melanoma, head and neck, colon, and esophageal tumors.
Novelos’ cancer-targeted compounds are selectively taken up and retained in cancer cells, including cancer stem cells, versus normal cells. Novelos’ therapeutic compounds appear to directly kill cancer cells while minimizing harm to normal cells. Novelos’ compounds, LIGHT, HOT, and GLOW2, offer the potential for a radical change in cancer therapy by working with 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. Novelos believes that LIGHT has first-in-class potential. 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. The company believes HOT also has first-in-class potential. HOT’s Phase 1b dose-escalation trial is ongoing. HOT is expected 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.
Taken together, the company believes all 3 of its cancer targeting compounds will give doctors the ability to “find, treat, and follow” cancer anywhere in the body in a novel, effective and highly selective way.
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