‒ Direct evidence demonstrates that CD206 is
major binding receptor for tilmanocept -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), today
announced the peer-reviewed publication of data verifying the
Lymphoseek® (technetium Tc 99m tilmanocept) injection CD206-binding
mechanism of action in the Journal of Immunology. Strong
evidence-based studies demonstrate macrophages are the major target
cell and identify CD206, the mannose receptor, as the
tilmanocept-binding receptor. CD206 is highly expressed on the
surface of tissue macrophages that are known to reside in the
sentinel lymph nodes (SLN) draining a primary tumor. Lymphoseek was
specifically designed to provide clinicians with a tool to reliably
and accurately locate the SLNs which have the highest likelihood of
containing metastasized cancer cells and to aid effective cancer
staging and inform post-surgical treatment.
"In our studies, we provide evidence that tilmanocept is the
first receptor-targeted cancer prognostic agent which is bound by
the mannose receptor as well as evidence of the potential mechanism
underlying the utility of tilmanocept. In particular we demonstrate
the specificity of binding, the tightness of binding and the strong
correlation of tilmanocept-binding to macrophages found in sentinel
lymph node tissue," said Larry S. Schlesinger M.D. with the Center
for Microbial Interface Biology, Department of Microbial Infection
and Immunity at The Ohio State University Wexner Medical Center and
PI of the study. “In practice this means the molecular nature of
tilmanocept allows it to rapidly enter into lymphatic channels,
localize in tumor-draining lymph nodes and bind to target
receptor(s) for longer retention in these SLNs giving it the
required characteristics for a potentially ideal agent for SLN
mapping.”
“This publication highlights data from rather elegant
experiments which confirm our belief that tilmanocept binds
primarily to macrophages found in the sentinel lymph nodes of
cancer patients and demonstrating its utility in identifying these
SLNs,” said Frederick O. Cope, Ph.D. FACN, Navidea’s Chief
Scientific Officer. “These results provide Lymphoseek with a clear
clinical differentiation from other non-targeted procedures and
enable additional opportunities for designing receptor-targeted,
advanced imaging agents and future potential for the delivery of
therapeutics for cancer and other macrophage-dependent
diseases.”
Lymphoseek is a receptor-targeted imaging agent that
was approved by the U.S. Food and Drug Administration (FDA)
for guiding sentinel lymph node biopsy in patients with clinically
node negative breast cancer, melanoma and squamous cell carcinoma
of the oral cavity as well as for lymphatic mapping in patients
with solid tumors for which this procedure is a component of
intraoperative management. In these procedures, key lymph nodes
adjacent to a primary tumor, that may contain tumor metastases, are
identified and biopsied to determine if cancer has spread to these
lymph nodes.
Summary of Results
A series of studies examined the receptor(s) for tilmanocept.
Using complementary approaches including competitive binding,
siRNA, Sentinel Lymph Node histochemistry and flow cytometry, the
data show that tilmanocept binds predominantly to human macrophages
and that the mannose receptor (CD206) is the major receptor for its
recognition. The authors conclude that this provides evidence for a
potential mechanism underlying the utility of tilmanocept as a
sensitive detector of lymph nodes that have the highest likelihood
of containing cancer cells if metastasis has occurred. For complete
details of the studies, findings and results, “γ-Tilmanocept, a New
Radiopharmaceutical Tracer for Cancer Sentinel Lymph Nodes, Binds
to the Mannose Receptor (CD206)” is published as an online article
in the Journal of Immunology’s “Next in the JI”. (J Immunol 140200;
published ahead of print July 22, 2015,
doi:10.4049/jimmunol.14020050)
About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the
first and only FDA-approved receptor-targeted lymphatic mapping
agent. It is a novel, receptor-targeted, small-molecule
radiopharmaceutical used in the evaluation of lymphatic basins that
may have cancer involvement in patients. Lymphoseek is designed for
the precise identification of lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer.
Lymphoseek is approved by the U.S. Food and Drug Administration
(FDA) for use in solid tumor cancers where lymphatic mapping is a
component of surgical management and for guiding sentinel lymph
node biopsy in patients with clinically node negative breast
cancer, melanoma or squamous cell carcinoma of the oral cavity.
Lymphoseek has also received European approval in imaging and
intraoperative detection of sentinel lymph nodes in patients with
melanoma, breast cancer or localized squamous cell carcinoma of the
oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. Overall in the U.S., solid tumor cancers may
represent up to 1.2 million cases per year. The sentinel node label
in the U.S. and Europe may address approximately 235,000 new cases
of breast cancer, 76,000 new cases of melanoma and 45,000 new cases
of head and neck/oral cancer in the U.S., and approximately 367,000
new cases of breast cancer, 83,000 new cases of melanoma and 55,000
new cases of head and neck/oral cancer diagnosed in Europe
annually.
Lymphoseek Indication and Important Safety
Information
Lymphoseek is a radioactive diagnostic agent indicated with or
without scintigraphic imaging for:
- Lymphatic mapping using a handheld
gamma counter to locate lymph nodes draining a primary tumor site
in patients with solid tumors for which this procedure is a
component of intraoperative management.
- Guiding sentinel lymph node biopsy
using a handheld gamma counter in patients with clinically node
negative squamous cell carcinoma of the oral cavity, breast cancer
or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity
reactions were reported, however Lymphoseek may pose a risk of such
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be
asked about previous hypersensitivity reactions to drugs, in
particular dextran and modified forms of dextran. Resuscitation
equipment and trained personnel should be available at the time of
Lymphoseek administration, and patients observed for signs or
symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer.
Adhere to dose recommendations and ensure safe handling to minimize
the risk for excessive radiation exposure to patients or health
care workers.
In clinical trials, no patients experienced serious adverse
reactions and the most common adverse reactions were injection site
irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND
AT:WWW.LYMPHOSEEK.COM
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics, therapeutics and
radiopharmaceutical agents. Navidea is developing multiple
precision-targeted products and platforms including Manocept™ and
NAV4694 to help identify the sites and pathways of undetected
disease and enable better diagnostic accuracy, clinical
decision-making, targeted treatment and, ultimately, patient care.
Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s
first commercial product from the Manocept platform, was approved
by the FDA in March 2013 and in Europe in November 2014. Navidea’s
strategy is to deliver superior growth and shareholder return by
bringing to market novel radiopharmaceutical agents and
therapeutics, and advancing the Company’s pipeline through global
partnering and commercialization efforts. For more information,
please visit www.navidea.com.
The Private Securities Litigation Reform Act of 1995 (the Act)
provides a safe harbor for forward-looking statements made by or on
behalf of the Company. Statements in this news release, which
relate to other than strictly historical facts, such as statements
about the Company’s plans and strategies, expectations for future
financial performance, new and existing products and technologies,
anticipated clinical and regulatory pathways, and markets for the
Company’s products are forward-looking statements within the
meaning of the Act. The words “believe,” “expect,” “anticipate,”
“estimate,” “project,” and similar expressions identify
forward-looking statements that speak only as of the date hereof.
Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially
from historical or anticipated results due to many factors
including, but not limited to, the Company’s continuing operating
losses, uncertainty of market acceptance of its products, reliance
on third party manufacturers, accumulated deficit, future capital
needs, uncertainty of capital funding, dependence on limited
product line and distribution channels, competition, limited
marketing and manufacturing experience, risks of development of new
products, regulatory risks and other risks detailed in the
Company’s most recent Annual Report on Form 10-K and other
Securities and Exchange Commission filings. The Company undertakes
no obligation to publicly update or revise any forward-looking
statements.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150723005761/en/
Navidea BiopharmaceuticalsTom Baker,
617-532-0624tbaker@navidea.comorSharon Correia,
978-655-2686Associate Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Apr 2024 to May 2024
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From May 2023 to May 2024