Navidea Biopharmaceuticals, Inc. Announces Results of Exploratory Analysis Completed on July 2, 2024
2024年7月4日 - 5:30AM
ビジネスワイヤ(英語)
Navidea Biopharmaceuticals, Inc. has completed an exploratory
analysis of its Rheumatoid Arthritis Program
Navidea Biopharmaceuticals, Inc. (OTC: NAVB) (“Navidea” or the
“Company”), a company focused on the development of precision
immunodiagnostic agents and immunotherapeutics, today announced
disappointing results of an exploratory analysis conducted on the
Company’s pivotal NAV3-33 clinical trial titled “Evaluation of Tc
99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα
Therapy Response in Patients with Moderate to Severe Active
Rheumatoid Arthritis (RA)” (ClinicalTrials.gov Identifier:
NCT05246280) the “RA Trial.”
The purpose of the exploratory analysis was to optimize the
diagnostic performance in support of the methodologies to be
applied in the final pivotal trial. The results confirm that
intravenous Tc 99m tilmanocept can target and produce reliable
images of macrophage activity in RA patients, but that these images
do not adequately predict which patients will respond to treatment
with an anti-TNF alpha medication.
"We were very surprised and disappointed that the results of the
exploratory analysis did not support the hypothesis of an overall
accuracy of early treatment response approaching 90%, but rather,
the overall accuracy of early treatment response was on average
consistently below 70%,” said Dr. Michael Blue, Navidea’s Chief
Medical Officer. "Results with that predictive value are not
indicative of a commercially viable product.”
Given these results, Navidea is suspending all activities
related to the RA Trial. The Company is pivoting to focus on
exploring all opportunities related to the Company’s therapeutic
assets.
About Navidea
Navidea Biopharmaceuticals, Inc. (OTC: 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, visit www.navidea.com.
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Investor Relations Navidea Biopharmaceuticals, Inc. Craig
A. Dais, Chief Financial Officer cdais@navidea.com
(614)-822-2322