Development of CLR1502 (GLOW2) Further Expands
Pipeline
Grant Zeng, CFA
On August 28, 2012,
Novelos Therapeutics, Inc. (
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.
Our Takeaways
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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