Full Press Release Details
Biosciences Announces Acceptance of Investigational New Drug Application to Evaluate I-131-CLR1404 in Clinical Trials in Relapsed
or Refractory Multiple Myeloma
MADISON, Wis., September 4, 2014,
- Cellectar Biosciences, Inc. (NASDAQ: CLRB), announced today that the U.S. Food & Drug Administration (FDA) has accepted
the Company's investigational new drug (IND) application to begin clinical study of I-131-CLR1404, a highly-selective, cancer-targeting
radiopharmaceutical, in patients with relapsed or refractory multiple myeloma, an incurable cancer of plasma cells.
I-131-CLR1404 is radiotherapeutic comprised
of a proprietary phospholipid ether (PLE) analog, acting as a cancer-targeted delivery and retention vehicle, covalently labeled
with Iodine-131, a cytotoxic radioisotope that is already commonly used to treat thyroid and other cancer types. Because Cellectar's
PLE platform has been shown to reliably and universally accumulate in malignant cancer cells, and the therapeutic properties of
the Iodine-131 isotope are well known, I-131-CLR1404 is engineered to combine an intracellular radiation mechanism of destroying
cancer cells, including cancer stem cells, through targeted delivery specific to malignant tissue that spares critical normal tissues
from consequential radiation dose.
Cellectar plans to initiate a Phase I/II,
proof-of-concept trial during the fourth quarter 2014 in approximately 20 patients with relapsed or refractory multiple myeloma
that have previously been treated with, or are intolerant of, an immunomodulator and a proteasome inhibitor. The primary objective
of the study will be to determine the safety and tolerability of I-131-CLR1404, with and without concurrent weekly dexamethasone.
In addition, the trial will seek to identify the recommended dose for future pivotal trials and determine therapeutic activity
of I-131-CLR1404 in this patient population as measured by overall response rate, time to progression and duration of response.
"This trial affords us an opportunity
to both assess the safety of I-131-CLR1404 in patients with multiple myeloma, but also to obtain near-term proof-of-concept data
characterizing the activity of I-131-CLR1404 in this difficult-to-treat patient population," commented Dr. Simon Pedder,
president and chief executive officer. "Having initiated a Phase II diagnostic imaging trial of our lead compound, I-124-CLR1404,
in glioblastoma earlier in the year, we are pleased to now have this opportunity to initiate a second, company-sponsored clinical
trial with the potential to showcase the therapeutic applications of our targeted delivery platform."
About Multiple Myeloma
According to the National Cancer Institute,
multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone
marrow. It is estimated that 70,000 people are living with multiple myeloma and 24,000 new cases are diagnosed annually in the
U.S., and that nearly 230,000 people are living with multiple myeloma and approximately 114,000 new cases are diagnosed annually,
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 presented at 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
Kate McNeil, Vice President of IR, PR & Corporate Communications
Cellectar Biosciences, Inc.
Phone: (347) 204-4226
Email: kmcneil@cellectar.com
This news release contains forward-looking
statements. You can identify these statements by our use of words such as "may," "expect," "believe,"
"anticipate," "intend," "could," "estimate," "continue," "plans," or
their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown
risks and uncertainties that may cause actual future experience and results to differ materially from the statements made.
These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development
involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related
to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies,
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
drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description
of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange
Commission including our Form 10-K for the year ended December 31, 2013. These forward-looking statements are made only as of the
date hereof, and we disclaim any obligation to update any such forward-looking statements.