Full Press Release Details
Biosciences Announces CLR1502 Development Program to be
Classified as Combination Product by U.S. Food and Drug Administration
to Re-submit Investigational Application as Combination Product Prior to Initiating
Proof-of-Concept Trial of Tumor Margin Illumination
Agent in Breast Cancer Surgery
MADISON, Wis., June 11, 2015, -
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection
and treatment of cancer, announced today that, after review of the company's investigational new drug (IND) application,
the U.S. Food and Drug Administration (FDA) has determined that Cellectar's tumor margin illumination agent, CLR1502, will
be evaluated as a combination product and assigned to the Center for Devices and Radiological Health (CDRH). As a result of this
classification, the FDA has advised Cellectar that it will need to submit a new investigational application for the combination
product prior to initiating its planned proof-of-concept trial in breast cancer surgery.
"Our tumor illumination agent shares
similar spectral qualities with indocyanine green (ICG), a fluorescent dye commonly used in medical diagnostics, and can therefore
use several commercially available fluorescent imaging devices. Current labeling for such devices is limited to FDA approved applications
such as cardiac, circulatory, hepatic and ophthalmic conditions," said Dr. Simon Pedder, president and chief executive officer
of Cellectar Biosciences. "Because of the groundbreaking nature of our overall technology and the potential for an agent
like CLR1502 to dramatically expand the utility of such imaging devices, we appreciate the agency's perspective and current
interest in evaluating CLR1502 in combination with a light source technology. As previously disclosed, in the course of our discussions
FDA regarding the CLR1502 registration program, the FDA has stressed that a combination product designation is not binding, can
be revised later in our development program, and that we are not necessarily precluded from filing a standalone NDA in the future."
CLR1502 is a small-molecule, broad-spectrum,
cancer-targeted, non-radioactive optical imaging agent developed by Cellectar to be the first of its kind for broad spectrum intraoperative
tumor margin illumination and non-invasive tumor imaging. CLR1502 is comprised of a proprietary phospholipid ether (PLE) analog,
acting as a cancer-targeted delivery and retention vehicle attached to a fluorophore to enable real-time visualization of malignant
tissue under near-infrared light.
CLR1502 is being developed for intraoperative
imaging of cancer that will aid in the identification of malignant tissue during diagnostic, staging, debulking and curative cancer
surgeries. In particular, the potential of CLR1502 in tumor margin illumination during oncologic resections raises the possibility
that this operative aid may improve surgical outcomes.
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 Phase I and Phase II product candidates engineered to leverage the unique characteristics
of cancer cells to "find, treat and follow" malignancies in a highly selective way. For additional information please
visit www.cellectar.com.
Kate McNeil, Vice President of IR, PR & Corporate Communications
Cellectar Biosciences, Inc.
Phone: (347) 204-4226
Email: kmcneil@cellectar.com
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the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA
review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize
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