Company Expects to Complete Ongoing Multi-Center Phase II
Imaging Trial of I-124-CLR1404 in Patients with Glioblastoma
By Year-End
MADISON, Wis., May 5, 2014 (GLOBE NEWSWIRE) — Cellectar Biosciences,
Inc. (OTCQX:CLRB), a clinical stage biopharmaceutical company
developing innovative agents for the detection and treatment of cancer,
announced that it has received notification from the U.S. Food and Drug
Administration (FDA) granting Cellectar’s request for orphan drug
designation for I-124-CLR1404 as a diagnostic for the management of
glioma, the most common and aggressive form of brain cancer.
The Orphan Drug Act provides for economic incentives to encourage the
development of drugs for diseases affecting fewer than 200,000 people
in the United States. Orphan drug designation will entitle Cellectar to
seven years of market exclusivity for I-124-CLR1404 as a diagnostic for
the management of glioma following marketing approval by the FDA.
Additional benefits include tax credits related to clinical trial
expenses, a possible exemption from the FDA-user fee, assistance in
clinical trial protocol design, and fewer patients required for new
drug applications.
Existing data from 18 patients previously evaluated in multiple,
investigator-sponsored brain tumor studies suggest that I-124-CLR1404
is selectively taken up and retained in malignant tumor cells, allowing
for the identification of malignant glioma cells in newly diagnosed
patients and distinguishing between true tumor progression and
pseudoprogression or radiation necrosis in patients with recurrent
malignant glioma.
“This orphan designation is a critical milestone in our program and
will facilitate our goal of rapidly developing I-124-CLR1404 as a
potentially new and effective imaging agent for patients with
glioblastomas,” said Dr. Simon Pedder, president and chief executive
officer of Cellectar Biosciences. “We believe I-124-CLR1404 has the
potential to dramatically improve the way glioma is managed by
affording clinicians the ability to effectively and reliably
characterize their findings as malignant tissue rather than
pseudoprogression or radiation necrosis, reducing the risk of
unnecessary surgical procedures or premature cessation of effective
therapy. Earlier this year, we initiated our first company-sponsored
Phase II imaging trial of I-124-CLR1404 in patients with glioblastoma
and look forward to completing this trial and reporting results by the
end of this year.”
Dr. John S. Kuo, principal investigator of the Phase II I-124-CLR1404
glioblastoma imaging trial and associate professor at University of
Wisconsin Carbone Cancer Center, states “During our national Brain
Tumor Awareness month in May, the FDA’s designation of I-124-CLR1404 as
an orphan drug recognizes the critical need of glioblastoma patients
for more effective diagnostic and therapeutic agents.”
About Glioma
Glioma, a type of tumor that starts in the brain and arises from glial
cells, is a broad category of tumors that are classified by cell type,
grade and location and accounts for approximately 80% of all primary
malignant brain tumors. The main glioma types are astrocytoma (which
includes glioblastoma), oligodendroglioma, ependymoma, and mixed
glioma. High-grade gliomas are rarely curable and the prognosis for
patients is poor.
Over 20,000 Americans are diagnosed each year with malignant brain
tumors. Glioblastoma, the most common primary adult brain cancer, is
rapidly life-threatening with most patients succumbing to the disease
within 15 months after diagnosis despite aggressive surgery, radiation
and chemotherapies.
About I-124-CLR1404
I-124-CLR1404 pairs Cellectar’s proprietary phospholipid ether analog
(PLE), acting as a cancer-targeted delivery and retention vehicle, with
iodine-124, a well-established positron emission tomography (PET)
imaging isotope with a radiation half-life of four days. In studies to
date, I-124-CLR1404 selectively illuminated malignant tumors in over 60
animal models of different cancer types, demonstrating broad-spectrum,
cancer-selective uptake and retention. Cellectar expects to complete a
Phase II trial evaluating I-124-CLR1404 in glioblastoma in 2014.
Additionally, multiple investigator-sponsored Phase I/II clinical
trials are ongoing across 11 solid tumor indications.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing agents to detect, treat and monitor
a broad spectrum of cancers. Using a novel phospholipid ether analog
(PLE) platform technology as a targeted delivery and retention vehicle,
Cellectar’s compounds are designed to be selectively taken up and
retained in cancer cells including cancer stem cells. With the ability
to attach both imaging and therapeutic agents to its proprietary
delivery platform, Cellectar has developed a portfolio of product
candidates engineered to leverage the unique characteristics of cancer
cells to “find, treat and follow” malignancies in a highly selective
way. I-124-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted
PET imaging agent currently being evaluated in a Phase II glioblastoma
imaging trial. Additionally, multiple investigator-sponsored Phase I/II
clinical trials are ongoing across 11 solid tumor indications.
I-131-CLR1404 is a small-molecule, broad-spectrum, cancer-targeted
molecular radiotherapeutic that delivers cytotoxic radiation directly
and selectively to cancer cells including cancer stem cells. A Phase Ib
dose-escalation trial of I-131-CLR1404 in patients with advanced solid
tumors was completed in the first quarter of 2014 and results have been
submitted to the American Society of Clinical Oncology (ASCO) 2014
Annual Meeting. CLR1502 is a preclinical, cancer-targeted,
non-radioactive optical imaging agent for intraoperative tumor margin
illumination and non-invasive tumor imaging. For additional information
please visit www.cellectar.com
