Cellectar Biosciences Reports High Rate of Complete Remission in Investigator Initiated Phase I Study of Iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer
March 04 2024 - 6:40AM
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage
clinical biopharmaceutical company focused on the discovery,
development, and commercialization of drugs for the treatment of
cancer, today announced that iopofosine I 131 in combination with
external beam radiation therapy (EBRT) was safe and tolerated in a
SPORE Grant supported investigator-initiated Phase 1 clinical
trial.
The twelve patients treated for locoregionally
recurrent head and neck squamous cell carcinoma previously received
chemoradiation alone (42%), surgery (58%) or surgery combined with
radiation or chemoradiation (92%). The data were presented in a
poster at the 2024 Multidisciplinary Head and Neck Cancers
Symposium held February 29-March 2, 2024, in Phoenix, AZ. (Click
HERE for poster.)
Complete remission was achieved in 64% of patients,
with an ORR of 73% (n=11). Prior to treatment with iopofosine I
131, six patients had multiple recurrence and one had metastatic
disease both of which are indicative of poor outcomes.
Additionally, the study demonstrated durability of tumor control
with an overall survival of 67% and progression free survival of
42% at 12 months.
“The study results underscore an important
quality of iopofosine to safely combine with external beam
radiotherapy and enhance therapeutic effect without significantly
increasing toxicity of treatment,” commented Andrei Shustov, SVP
Medical. “The durability of responses demonstrated by impressive
progression free and overall survival in this patient population
suggests that the combination of iopofosine and EBRT may target the
primary tumor as well as micrometastatic disease beyond the
conventional radiation field. This might result in synergistic
therapeutic benefit applicable to a variety of solid tumors.”
The patients received two therapeutic doses of
iopofosine I 131 at a fixed fractionated dose of 15.6 mCi/m2 (days
1 and 8) with SPECT/CT imaging performed to quantitate the
biodistribution of iopofosine I 131. Patients subsequently received
EBRT to complete the designated radiation dose outlined in the
reirradiation plan, which was 60-70 Gray.
“In addition to positive data previously
reported in hematologic malignancies including recent results from
our pivotal CLOVER WaM study in Waldenstrom’s macroglobulinemia,
these data further demonstrate iopofosine’s broad clinical activity
in solid tumors,” said James Caruso, president and CEO. “We are
clearly pleased with these results which remain consistent with
prior reported data demonstrating deep and durable responses with
iopofosine treatment, including complete remissions, in a wide
spectrum of malignancies.”
Overall, eleven patients (92%) experienced a
treatment-related adverse event. The most common treatment-related
adverse events of any grade were thrombocytopenia (92%),
lymphopenia (75%), neutropenia (75%), and anemia (92%). Observed
adverse events were consistent with the known toxicity profile of
iopofosine I 131, with cytopenias being the most common with all
patients recovering.
About Recurrent Head and Neck
CancerSquamous cell carcinoma of the head and neck (SCCHN)
represents the sixth most common malignancy worldwide and its mean
incidence rate is about 20 per 100,000 people or almost 67,000
newly diagnosed cases each year. About 50% of these patients will
experience a recurrence of disease. Patients with recurrent SCCHN
have a median overall survival of approximately 12 months.
About Cellectar Biosciences,
Inc.Cellectar Biosciences is a late-stage clinical
biopharmaceutical company focused on the discovery and development
of proprietary drugs for the treatment of cancer, independently and
through research and development collaborations. The company’s core
objective is to leverage its proprietary Phospholipid Drug
Conjugate™ (PDC) delivery platform to develop the next-generation
of cancer cell-targeting treatments, delivering improved efficacy
and better safety as a result of fewer off-target effects.
The company’s product pipeline includes lead asset
iopofosine I 131, a small-molecule PDC designed to provide targeted
delivery of iodine-131 (radioisotope), proprietary preclinical PDC
chemotherapeutic programs and multiple partnered PDC assets.
For more information, please visit
www.cellectar.com and www.wmclinicaltrial.com or join the
conversation by liking and following us on the company’s social
media channels: Twitter, LinkedIn, and Facebook.
Forward-Looking Statement
Disclaimer
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 including our
expectations regarding the WM CLOVER-WaM pivotal trial. 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 disruptions at our sole source
supplier of iopofosine, the ability to attract and retain partners
for our technologies, the identification of lead compounds, the
successful preclinical development thereof, patient enrollment and
the completion of clinical studies, the FDA review process and
other government regulation, our ability to maintain orphan drug
designation in the United States for iopofosine, the volatile
market for priority review vouchers, 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, 2022, and our Form 10-Q for the quarter ended
September 30, 2023. These forward-looking statements are made only
as of the date hereof, and we disclaim any obligation to update any
such forward-looking statements.
Contacts
MEDIA:Claire LaCagninaBliss Bio
Health315-765-1462clacagnina@blissbiohealth.com
INVESTORS:Chad KoleanChief Financial
Officerinvestors@cellectar.com
Cellectar Biosciences (NASDAQ:CLRB)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cellectar Biosciences (NASDAQ:CLRB)
Historical Stock Chart
From Jul 2023 to Jul 2024