Navidea Biopharmaceuticals Announces Submission of Formal Type B Meeting Request with FDA & Launch of NAV3-32 Phase 2B Trial ...
February 08 2021 - 04:05PM
Business Wire
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB)
(“Navidea” or the “Company”), a company focused on the development
of precision immunodiagnostic agents and immunotherapeutics, is
pleased to announce that the Company has submitted its formal Type
B Meeting Request to the FDA. The FDA has granted the Type B
meeting and has requested submission of the Briefing Book. The FDA
will now review the Company’s formal briefing documents containing
results from the NAV3-31 Phase 2B study and the proposed Phase 3
design and protocol. Navidea’s previous and ongoing clinical
studies in Rheumatoid Arthritis (“RA”) will also be provided.
Navidea expects formal feedback from the FDA within the next
several months and a potential launch of the pivotal Phase 3 study
in the second quarter of 2021.
This pivotal Phase 3 trial will establish the ability of Tc99m
tilmanocept imaging to serve as an early predictor of treatment
response in RA patients switching to an anti-TNFα therapy. The
design and planned conduct of the Phase 3 trial is built upon data
from Navidea’s ongoing NAV3-31 Phase 2B trial that is providing
supportive evidence that Tc99m tilmanocept imaging can provide
robust, quantitative imaging in patients with active RA and that
this imaging can provide an early indicator of treatment
response.
Navidea is also pleased to announce the opening of the first US
site for enrollment in its NAV3-32 Phase 2B trial titled, “A
Comparison of Tc99m Tilmanocept Quantitative Imaging with
Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial
Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis
(RA).” This trial will examine the correlation of Tc99m tilmanocept
imaging quantification to the macrophage number and density and
immune cell composition in joints. This may permit Tc99m
tilmanocept imaging to act as a “virtual biopsy,” characterizing a
patient’s individual RA pathological subtype with potential to
predict therapeutic responses beyond those of anti-TNFα
therapies.
Michael Rosol, Chief Medical Officer for Navidea, said, “We are
eager to receive feedback from the FDA on our NAV3-31 Phase 3
design, and are excited to have opened up our first site in the
important NAV3-32 trial. Throughout our RA program development, we
have worked closely with expert rheumatologists, nuclear medicine
specialists, and the FDA itself, and we believe we are on the right
path to bring a valuable tool to bear to meet a large unmet medical
need of patients with RA.” Dr. Rosol continued, “Success of these
trials would mean that we can provide rheumatologists and those
suffering with RA a noninvasive, quantifiable, early indicator of
whether or not an anti-TNFα treatment is working. This could bring
enormous benefit to these patients by assisting physicians in
putting them on the right course of treatment earlier than would
otherwise be possible today.”
Jed Latkin, Navidea’s Chief Executive Officer, said, “I am
pleased that the FDA responded so quickly to the meeting request
and look forward to a constructive dialogue with the FDA over the
two months. Furthermore, the launch of NAV3-32 is a momentous step
in the Company’s drive towards the eventual approval of both the RA
monitoring agent and the use of Tilmanocept as a key biomarker for
inflammation. While COVID might have slowed the development
timeline we remain focused on opening more sites for NAV3-32 as
lockdowns in the UK and Europe subside.”
RA is a chronic disease affecting over 1.3 million Americans and
as much as 1% of the worldwide population1. If the product is
successfully developed, Navidea would expect to play a major role
in the management of RA patients worldwide.
Reference 1.
https://www.rheumatoidarthritis.org/ra/facts-and-statistics/
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210208005847/en/
Navidea Biopharmaceuticals, Inc. Jed Latkin Chief Executive
Officer 614-973-7490 jlatkin@navidea.com
Joel Kaufman Chief Business Officer 614-822-2372
jkaufman@navidea.com
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