Navidea Biopharmaceuticals Completes Full Enrollment in Phase 2b Normative Database Study to Support its Rheumatoid Arthritis Program
December 15 2021 - 4:02PM
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 it has achieved full enrollment in its NAV3-35 Phase
2b clinical study titled “Development of a Normative Database for
Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept.”
Establishing a healthy subject database is necessary to create a
quantitative method for determining RA-involved inflammation in
joints. The NAV3-35 Phase 2b clinical trial accomplishes this goal.
The trial has two arms, with Arm 1 designed to acquire hand and
wrist planar (two-dimensional) images from healthy subjects that
were age and sex-matched to the RA population and injected with
Tc99m tilmanocept. Arm 2 is a pilot feasibility study to examine
the potential of three-dimensional SPECT/CT imaging of the hands
and wrists of healthy subjects and patients with RA injected with
Tc99m tilmanocept. The main objective of the trial is to complete
the healthy subject (normative) database in support of the
Company’s RA imaging commercial product development. A total of 120
healthy volunteers were enrolled in Arm 1. Enrollment is also
finalized in Arm 2 of the study.
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 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, the
primary indication the Company is pursuing in RA in the upcoming
Phase 3 trial.
This database will also be used in the training of automated
image analysis software to further improve the accuracy of the
quantification of Tc99m tilmanocept localization in joints as well
as the workflow for later commercialization in RA.
Dr. Michael Rosol, the Company’s Chief Medical Officer, said,
“We are pleased to have reached this important milestone in our RA
program pipeline. This healthy subject normative database will
allow us to define the parameters of what a normal joint looks like
with Tc99m tilmanocept, and with that information we can improve
upon the quantitative determination of RA-inflamed joints.” Dr.
Rosol continued, “This database will play an essential part in both
the Phase 3 data analysis as well as commercial product. It will
not only enable us to more accurately quantitate RA-involved
inflammation but, along with the proprietary algorithm we use to
read the images, it will serve as an additional barrier to entry
for possible long-term competition. This is a critical step forward
in the advancement of our RA program into the upcoming Phase 3
trial.”
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
our current expectations and projections about future events and
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Forward-looking statements include our expectations regarding
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assumptions, including, among other things: our history of
operating losses and uncertainty of future profitability; the fact
that the valuation by LifeSci Partners of our Tc99m tilmanocept
pipeline product is subject to and based on numerous assumptions
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Navidea Biopharmaceuticals, Inc. Jeffrey Smith Vice President of
Operations 614-822-2365 jsmith@navidea.com
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