FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatment of Rhabdomyosarcoma
06 Juin 2018 - 2:00PM
Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of drugs for the treatment of cancer, announces
today that the U.S. Food and Drug Administration (FDA) has granted
Rare Pediatric Disease Designation (RPDD) to CLR 131, the company’s
lead Phospholipid Drug Conjugate™ (PDC) product candidate, for the
treatment of rhabdomyosarcoma, a rare pediatric cancer.
“There is a critical need for new therapies in the fight against
deadly diseases such as rhabdomyosarcoma and we continue to
increase our focus on delivering innovative solutions to patients
suffering from such rare cancers,” said John Friend, M.D., chief
medical officer of Cellectar. “The grant of a second RPDD
represents an additional regulatory milestone for CLR 131 and we
look forward to working with the FDA to advance development of CLR
131 as rapidly as possible, to fully evaluate its potential as a
therapeutic option for rhabdomyosarcoma.”
Last month, Cellectar announced that the FDA also granted RPDD
for CLR 131 for the treatment of neuroblastoma. If CLR 131 is
approved by the FDA for either neuroblastoma or rhabdomyosarcoma,
the rare pediatric disease designation may enable Cellectar to
receive a priority review voucher. Priority review vouchers can be
used by the sponsor to receive priority review for a future NDA or
BLA submission, which would reduce the FDA review time from 12
months to six months. Currently, these vouchers can also be
transferred or sold to another entity. Over the last 16 months,
five priority review vouchers were sold for between $110 million to
$150 million each.
The FDA grants RPDD for diseases that primarily affect
children from birth to 18 years old, and affect fewer than 200,000
persons in the U.S. This program is intended to encourage
development of new drugs and biologics for the prevention and
treatment of rare pediatric diseases.
About RhabdomyosarcomaRhabdomyosarcoma (RMS), a
malignant tumor of mesenchymal origin, is the most common soft
tissue sarcoma in children, accounting for approximately 40% of
childhood soft tissue sarcomas in the U.S. The annual incidence is
about 4.5 cases per 1 million in children younger than 15 years and
more than 50% are younger than 10 years at diagnosis. RMS has a 64%
five-year survival in a pediatric population, with at least
one-third of all patients experiencing disease progression or
relapse [Ward 2014]. The median progression-free survival following
the first recurrence or progression is approximately nine
months.
About CLR 131CLR 131 is Cellectar’s
investigational radioiodinated PDC therapy that exploits the
tumor-targeting properties of the company's proprietary
phospholipid ether (PLE) and PLE analogs to selectively deliver
radiation to malignant tumor cells, thus minimizing radiation
exposure to normal tissues. CLR 131, is in a Phase 2 clinical study
in relapsed or refractory (R/R) MM and a range of B-cell
malignancies and a Phase 1 clinical study in patients with (R/R) MM
exploring fractionated dosing. In 2018 the company plans to
initiate a Phase 1 study with CLR 131 in pediatric solid tumors and
lymphoma, and a second Phase 1 study in combination with external
beam radiation for head and neck cancer.
About Cellectar Biosciences, Inc.Cellectar
Biosciences is focused on the discovery, development and
commercialization of drugs for the treatment of cancer. The company
plans to develop proprietary drugs independently and through
research and development (R&D) collaborations. The core drug
development strategy is to leverage our PDC platform to develop
therapeutics that specifically target treatment to cancer cells.
Through R&D collaborations, the company’s strategy is to
generate near-term capital, supplement internal resources, gain
access to novel molecules or payloads, accelerate product candidate
development and broaden our proprietary and partnered product
pipelines.
The company's lead PDC therapeutic, CLR 131, is in a Phase 1
clinical study in patients with relapsed or refractory (R/R) MM and
a Phase 2 clinical study in R/R MM and a range of B-cell
malignancies. In the second half of 2018 the company plans to
initiate a Phase 1 study with CLR 131 in pediatric solid tumors and
lymphoma, and a second Phase 1 study in combination with external
beam radiation for head and neck cancer. The company’s product
pipeline also includes two preclinical PDC chemotherapeutic
programs (CLR 1700 and 1900) and partnered assets include PDCs from
multiple R&D collaborations.
For more information please visit www.cellectar.com.
Forward-Looking Statement DisclaimerThis 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, 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, 2017. These forward-looking
statements are made only as of the date hereof, and we disclaim any
obligation to update any such forward-looking statements.
CONTACT: LHA Investor RelationsMiriam
Weber Miller212-838-3777mmiller@lhai.com
Cellectar Biosciences (NASDAQ:CLRBW)
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