– Data from three proof-of-concept studies reported at the
Annual Meeting of the Society of Nuclear Medicine and Molecular
Imaging (SNMMI) –
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced results from three research
studies performed with collaborators that demonstrate the potential
for the Company’s Manocept™ platform imaging agents to diagnose and
stage rheumatoid arthritis (RA) and Kaposi’s Sarcoma (KS). The data
were presented by scientific collaborators at the 2014 Annual
Meeting of the Society of Nuclear Medicine and Molecular Imaging
(SNMMI) in St. Louis, MO.
“These data reinforce the potential for our macrophage-targeting
Manocept platform, from which our FDA-approved product Lymphoseek®
(technetium 99m tilmanocept) Injection is derived, to significantly
expand our commercial opportunities by addressing
immuno-inflammatory disorders,” commented Frederick Cope, Ph.D.,
Senior Vice President and Chief Scientific Officer of Navidea. “The
core mechanism of the Manocept platform is its ability to bind to
the mannose receptor (CD206), enabling Manocept-derived molecules
to uniquely seek out, identify and accumulate in macrophages, which
are an emerging marker of disease-associated inflammation. By
targeting macrophages, Manocept-derived agents represent a
potentially powerful approach to helping physicians diagnose, treat
and monitor patients with inflammation-based disorders such as RA
and KS.”
Experimental Preclinical Results
The results of two studies conducted at The Ohio State
University Wexner Medical Center indicated that CD206-targeted
imaging agents based on the Manocept platform show strong potential
as in vivo imaging agents to detect immune-mediated inflammation
with possible use in early diagnosis and monitoring of therapeutic
efficacy in RA. Wael Jarjour, M.D., Associate Professor and
Director, Division of Rheumatology & Immunology, presented data
using the CD206-targeted fluorescent imaging agent Cy3-tilmanocept,
demonstrating that archival synovial tissue and synovial fluid
obtained from patients diagnosed with RA contain a significant
population of macrophages that express high-levels of the CD206
receptor. It was shown that these macrophages strongly co-localize
Cy3-tilmanocept and CD206 receptors. The degree of macrophage
infiltration in tissue from healthy or osteoarthritic patients was
significantly lower than in RA tissues.
Thomas Rosol, D.V.M., Ph.D., Professor, Department of Veterinary
Biosciences, presented data evaluating intravenous administration
of Cy3-tilmanocept in mice with induced RA to determine joint
localization and specificity. Cy3-tilmanocept was demonstrated to
preferentially localize to macrophages in affected joints with
little to no localization in unaffected joints.
Results from studies at University of California San Francisco
in Kaposi’s Sarcoma confirmed findings in a previous macrophage
expression study that Manocept-based agents represent an
opportunity for dynamic imaging, local staging and a potential
ability to detect and monitor for visceral KS metastasis. Michael
S. McGrath, M.D., Ph.D., Professor, Departments of Laboratory
Medicine, Pathology, and Medicine presented data compiled from 66
KS cases and controls which validate previous research observations
that both tumor associated macrophages (TAMs) and KS tumor cells
express CD206 mannose receptors. Immuno-histochemistry analysis of
the KS samples showed that expression of CD206 macrophage antigens,
found to be the most prevalent for both KS tumor spindle cells and
TAMs, was similar across all tissue forms of KS including plaque,
oral and visceral.
The poster presentations can be found on the Navidea website in
the Publications (http://www.navidea.com/development-programs/publications/bibliography.html
) section:
- “Fluorescent CD206-targeted
Manocept-Cy3 (Mano-Cy3) specifically localizes on macrophages (MPs)
derived from rheumatoid arthritis (RA) patients' synovial fluid
& is quantitatively greater than that from non-RA
patients”;
- “lntravenous administration (lV) of the
CD206-targeted Manocept-Cy3 (Mano-Cy3) to mice with induced
rheumatoid arthritis (RA) results in heterogeneous localization of
Mano-Cy3 with strong specificity for RA-expressing joints”;
and
- “CD206-targeted Cy3-Manocept (Mano-Cy3)
localizes in nearly all cells present in Kaposi's sarcoma
representing an opportunity for dynamic imaging, local staging and
a potential for visceral metastasis imaging”
About the Manocept™ Platform
Navidea’s Manocept platform is predicated on the ability to
specifically target the CD206 mannose receptor expressed on
macrophages. Macrophages play important roles in many disease
states and are an emerging target in many disorders where
diagnostic uncertainty exists. This flexible and versatile platform
acts as an engine for purpose-built molecules that may enhance
diagnostic accuracy, clinical decision-making and ultimately
patient care, while offering the potential to utilize a breadth of
diagnostic imaging modalities, including SPECT, PET,
intra-operative and/or optical-fluorescence detection. The
Company’s FDA-approved precision diagnostic lymphatic mapping
agent, Lymphoseek® (technetium 99m tilmanocept) Injection, is
representative of the ability to successfully exploit this
mechanism to develop powerful, new diagnostic agents.
About Lymphoseek®
Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a
novel, receptor-targeted, small-molecule radiopharmaceutical used
in lymphatic mapping procedures that are performed to help in the
diagnostic evaluation of potential cancer spread for patients with
breast cancer and melanoma. Lymphoseek is designed to identify the
lymph nodes that drain from a primary tumor, which have the highest
probability of harboring cancer. Lymphoseek was approved by the
U.S. Food and Drug Administration (FDA) in March, 2013 for use in
lymphatic mapping to assist in the localization of lymph nodes
draining a primary tumor in patients with breast cancer or
melanoma. The Company anticipates continuing development of
Lymphoseek into other solid tumor areas that may include other head
and neck cancers such as thyroid cancer, prostate cancer and
cancers of the female reproductive system (e.g., cervix,
endometrial and vulva cancer). Lymphoseek was granted Fast Track
and Priority Review designation for its sNDA for sentinel lymph
node detection in patients with head and neck cancer and is
currently in review with the FDA.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. According to publicly available information,
approximately 235,000 new cases of breast cancer, 76,000 new cases
of melanoma and 69,500 new cases of head and neck/oral cancer are
expected to be diagnosed in the United States in 2014, and
approximately 367,000 new cases of breast cancer, 83,000 new cases
of melanoma and 137,000 new cases of head and neck/oral cancer
diagnosed in Europe annually.
U.S. Indication and Important Safety Information About
Lymphoseek
Indication
Lymphoseek (technetium Tc 99m tilmanocept) Injection is a
lymphatic mapping agent indicated for use with a hand-held gamma
counter to assist in the localization of lymph nodes draining a
primary tumor site in patients with 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.
The most common adverse reactions are injection site irritation
and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM
About Navidea Biopharmaceuticals Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics and radiopharmaceutical
agents. Navidea is developing multiple precision diagnostic
products and platforms, including NAV4694, NAV5001, Manocept™ and
NAV1800 (RIGScan™), to help identify the sites and pathways of
undetected disease and enable better diagnostic accuracy, clinical
decision-making and, ultimately, patient care. Lymphoseek®
(technetium 99m tilmanocept) Injection, Navidea’s first commercial
product from the Manocept platform, was approved by the FDA in
March 2013. Navidea’s strategy is to deliver superior growth and
shareholder return by bringing to market novel radiopharmaceutical
agents and advancing the Company’s pipeline through selective
acquisitions, 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.
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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