In parallel with the ongoing Phase 1b fourth cohort, Novelos will be evaluating a range of potential HOT Phase 2 indications and trial designs including incorporation of multiple dosing, as well as combination of HOT with external beam radiotherapy or with radiosensitizing therapeutics.
GLOW2 is a preclinical, cancer-targeted, non-radioactive optical imaging agent for both intraoperative tumor margin illumination and non-invasive tumor imaging. Novelos plans to file an Investigational New Drug Application (IND) for GLOW2 by the end of 2013 and, subject to additional funding, expects to generate proof-of-concept data in cancer patients by the end of 2014. GLOW2 may address the significant unmet medical need for better definition of tumor margins and nodal involvement, potentially reducing repeat surgeries and improving patient outcomes.
"A good example of the potential utility of CLR1502 (GLOW2) is in breast cancer surgery, where 25% of patients undergoing lumpectomy require repeat resection due to incomplete removal of the primary tumor and malignant lymph nodes," said Lee Wilke, M.D., Associate Professor (CHS), Division of General Surgery, and Director Breast Center at the University of Wisconsin Carbone Cancer Center. "An imaging agent that enables improved surgical accuracy by better defining malignant tissues could significantly improve patient outcomes and rapidly impact medical practice."
Mr. Palmin further noted, "Based on positive initial LIGHT imaging results in primary and metastatic brain cancer, we believe LIGHT has potential to address a significant unmet medical need for post-treatment efficacy assessment and differentiating tumor growth from pseudoprogression in brain cancer, potentially avoiding unnecessary surgeries, biopsies and other treatments. While LIGHT human imaging data is confirming the broad-spectrum potential of our cancer-targeted technology, it is also expected to guide us in selecting a therapeutic direction with HOT. Additionally, we will utilize the clinical data generated with HOT to date as we evaluate potential HOT Phase 2 indications and trial designs. With GLOW2, there is strong medical support for the need to improve outcomes of tumor surgery, including reducing repeat resections and early progression, stemming from incomplete removal of malignant tissue or lymph nodes. Each of these compounds exploits the same key attribute of our proprietary, cancer-targeted delivery platform based on phospholipid ether analogs (PLE); the enabling of selective uptake and prolonged retention in cancer cells. We look forward to advancing the development of these compounds as well as exploring additional applications of our delivery platform in the oncology space."