Navidea Biopharmaceuticals Announces First 110 Subjects Imaged in NAV3-35 Normative Database Phase 2b Study to Support Rheuma...
July 19 2021 - 07:30AM
Business Wire
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB)
(“Navidea” or the “Company”), a company focused on the development
of precision immunodiagnostic agents and immunotherapeutics, today
announced that over 110 subjects have been enrolled and imaged in
its NAV3-35 Phase 2b study, “Development of a Normative Database
for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept.”
Expected total enrollment for this two-arm trial will be 135
participants.
NAV3-35 will establish a database of hand and wrist images taken
following Tc99m tilmanocept administration in healthy volunteers
age- and sex-matched to the population of RA patients. Tc99m
tilmanocept attaches to mannose receptors (CD206) on macrophages
that are frequently involved in RA joint inflammation. Relatively
smaller numbers of CD206 expressing macrophages normally reside in
the joints of healthy people without RA. An integral part of the
ability to quantitatively discriminate RA-inflamed joints from
those that do not have inflammation using Tc99m tilmanocept imaging
is the knowledge of the distribution of Tc99m tilmanocept
localization in healthy joints. The establishment of this normal
subject database (i.e., normative database) will enable improved
accuracy of discrimination of RA-involved joints from non-RA
inflamed joints and should have a positive impact on the ability to
predict treatment response early. This database will also be used
in the training of automated image analysis algorithms to further
improve the accuracy of the quantification of Tc99m tilmanocept
localization in joints as well as the workflow for later
commercialization in RA.
The aim is to recruit 135 volunteers in this two-arm study. The
first arm is comprised of 120 healthy subjects who will have planar
imaging of their hands and wrists post administration of Tc99m
tilmanocept, and arm two is a 15-subject arm comprised of 10
patients with RA and 5 healthy volunteers with the aim of
demonstrating the feasibility of 3-dimensional SPECT/CT imaging for
the quantitative assessment of RA-involved inflammation in joints.
To date, over 100 subjects have been imaged for Arm 1, and 10 in
Arm 2.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “The
normative database, establishing the parameters of what a normal
joint looks like with Tc99m tilmanocept, will play an essential
part in both the Phase 3 data analysis as well as planned
commercial product.” Dr. Rosol continued, “These data will also be
used to optimize automated image analysis to improve upon accuracy
and streamline workflow for widespread adoption of Tc99m
tilmanocept imaging in RA.”
Jed Latkin, Chief Executive Officer and Chief Financial Officer
for Navidea, said, “The rapid enrollment of this trial is truly a
testament to Navidea’s focus on delivering quick results as we
launch more trials to bring the Company ever closer to the
launching of the RA Diagnostic product.”
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a
biopharmaceutical company focused on the development of precision
immunodiagnostic agents and immunotherapeutics. Navidea is
developing multiple precision-targeted products based on its
Manocept™ platform to enhance patient care by identifying the sites
and pathways of disease and enable better diagnostic accuracy,
clinical decision-making, and targeted treatment. Navidea’s
Manocept platform is predicated on the ability to specifically
target the CD206 mannose receptor expressed on activated
macrophages. The Manocept platform serves as the molecular backbone
of Tc99m tilmanocept, the first product developed and
commercialized by Navidea based on the platform. Navidea’s strategy
is to deliver superior growth and shareholder return by bringing to
market novel products and advancing the Company’s pipeline through
global partnering and commercialization efforts. For more
information, please visit www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. We have based these forward-looking statements largely on
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financial trends affecting the financial condition of our business.
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operating losses and uncertainty of future profitability; the final
outcome of any pending litigation; our ability to successfully
complete research and further development of our drug candidates;
the timing, cost and uncertainty of obtaining regulatory approvals
of our drug candidates; our ability to successfully commercialize
our drug candidates; dependence on royalties and grant revenue; our
ability to implement our growth strategy; anticipated trends in our
business; our limited product line and distribution channels;
advances in technologies and development of new competitive
products; our ability to comply with the NYSE American continued
listing standards; our ability to maintain effective internal
control over financial reporting; the impact of the current
coronavirus pandemic; and other risk factors detailed in our most
recent Annual Report on Form 10-K and other SEC filings. You are
urged to carefully review and consider the disclosures found in our
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Navidea Biopharmaceuticals, Inc. Jed Latkin Chief Executive
Officer 614-973-7490 jlatkin@navidea.com
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