Navidea Reports Manocept™ Study Results in Rheumatoid Arthritis Presented at EULAR 2015 European Congress of Rheumatology
June 11 2015 - 7:30AM
Business Wire
Navidea Biopharmaceuticals (NYSE MKT:NAVB), announced that
results from several pre-clinical Manocept™ studies in rheumatoid
arthritis (RA) were presented at the EULAR 2015 European
Congress of Rheumatology in Rome, Italy from June 10-13, 2015.
The results of studies, led by Wael Jarjour, Thomas J. Rosol and
Larry S. Schlesinger of The Ohio State University Wexner Medical
Center, highlighted the potential of CD206-targeting Manocept
constructs to detect immune-mediated inflammation in RA which could
be used diagnostically, to monitor therapeutic efficacy or as a
potential therapeutic platform.
“Diagnosing patients with RA can be challenging because the
commonly used laboratory assays are negative in 20% of affected
patients. Additionally, there are limited reliable tools to assess
disease activity and guide therapy in patients with difficult
clinical presentations,” said Wael Jarjour, M.D., Associate
Professor and Director, Division of Rheumatology & Immunology,
The Ohio State University Wexner Medical Center. “We believe that
Manocept-targeting of macrophages shows promise in detecting
immune-mediated inflammation in RA and could potentially be used
diagnostically or to monitor therapeutic efficacy in patients.”
“These studies continue to support our vision for the Manocept
platform to further develop diagnostic and therapeutic applications
and are very relevant to our ongoing joint venture with RNAV
focused on RA,” said Frederick O. Cope, Ph.D. FACN, Navidea’s Chief
Scientific Officer. “We envision future studies in this area will
be undertaken to explore the applicability of these observations in
prodromal and established patients and further to investigate the
potential of Manocept platform therapeutically to either inhibit
macrophage function or modulate macrophage activity.”
The oral presentation entitled, “Manocept, a Derivative of
FDA-Approved 99mTc-Tilmanocept, Exhibits Diagnostic Potential by
Specifically Identifying Macrophages in Rheumatoid Arthritis: A
Novel Application of an Existing Drug,” (DOI:
10.1136/annrheumdis-2015-eular.4876) showed results from synovial
fluid and tissue acquired from RA patients for comparison to normal
frozen archival tissue and synovial tissue procured from patients
with osteoarthritis (OA). Tissues were probed with Manocept-Cy3,
DAPI nuclear stain, and anti CD206-cyanine. Mononuclear cells were
isolated from RA synovial fluid and analyzed by flow cytometry.
Results demonstrated 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 Manocept-Cy3 and CD206 receptors. The degree of
macrophage infiltration in tissue from healthy or osteoarthritic
patients was significantly lower than in RA tissues. Additionally
in an in vivo animal study, arthritis was induced in mice and was
followed with intravenous injection of Manocept-Cy3 and
epi-fluorescent imaging. Imaging results indicated that Manocept
can be detected in inflamed joints in an in vivo animal model of
RA. The abstract is available at:
http://www.congress.eular.org/scientific_programme.cfm.
About the Manocept™ CD206-targeting platform
The 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. This flexible
and versatile platform acts as an engine for purpose-built
molecules that may enhance diagnostic accuracy, clinical
decision-making, targeted treatments and ultimately patient care.
As a diagnostic tool, the Manocept technology has the potential to
utilize a breadth of imaging modalities, including SPECT, PET,
intra-operative and/or optical-fluorescence detection. By adding a
therapeutic agent on the Manocept molecular backbone, there is the
potential to develop novel, targeted immunotherapies specifically
designed to selectively deliver an agent that can kill or alter
disease-associated macrophages. Navidea’s FDA-approved precision
diagnostic imaging agent, Lymphoseek® (technetium 99m tilmanocept)
injection, is representative of the platform’s ability to
successfully exploit this mechanism and offer the potential for
development of new CD206-targeted diagnostic agents and
therapeutics.
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.
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Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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