Navidea Biopharmaceuticals Announces Launch of Phase 3 Clinical Trial in Rheumatoid Arthritis
December 16 2021 - 4:01PM
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 the launch of the NAV3-33 Phase 3 clinical trial titled
“Evaluation of Tc99m Tilmanocept Imaging for the Early Prediction
of Anti-TNFα Therapy Response in Patients with Moderate to Severe
Active Rheumatoid Arthritis (RA).”
This Phase 3 trial will establish the ability of Tc99m
tilmanocept imaging to serve as an early predictor of treatment
response in rheumatoid arthritis (“RA”) patients switching to an
anti-TNFα therapy. Trial details will be posted to
clinicaltrials.gov.
Rheumatoid Arthritis is a serious and potentially debilitating
disease. The standard practice of treating RA is to monitor
patients initiating new RA therapies over a course of three to six
months and, in those patients for which the new therapies prove to
be ineffective, to change their treatments to an alternative
therapy with a different mechanism of action. This trial-and-error
process of appropriate treatment selection may take several months
to more than a year to arrive at an adequate treatment for any RA
patient. Imaging with Tc99m tilmanocept, a synthetic molecule with
high affinity to CD206 receptors expressed on activated
macrophages, offers the potential to provide an early predictor of
clinical response by providing an objective, quantifiable readout
of changes in macrophage density in the joints of patients
undergoing initiation or change of therapy. These macrophage
density changes may be observable weeks before disease modification
can be detected with standard clinical assessments.
The data from the Company’s completed NAV3-31 Phase 2b trial
demonstrated that Tc99m tilmanocept can provide robust,
quantitative imaging in both healthy controls and in patients with
active RA, and that this imaging is reproducible and can define
joints with and without RA-involved inflammation. The Phase 2b also
provided evidence in support of the hypothesis that Tc99m
tilmanocept can provide an early prediction of treatment efficacy
in patients switching to an anti-TNFα therapy.
The design of the Phase 3 trial is built upon insights and data
from this completed Phase 2b study, as well as input from the
recent End of Phase 2 Type B meeting with the FDA. The NAV3-33
Phase 3 trial will involve Tc99m tilmanocept imaging in patients
with RA who are about to begin an anti-TNFα therapy. Planar
(two-dimensional) images of the hands and wrists taken at baseline
prior to initiation of therapy and at week 5 following start of
therapy will be quantitatively evaluated to assess changes in Tc99m
tilmanocept signal localization, if any, in order to predict
treatment response or non-response as determined by standard
clinical assessments at three and six months post therapy
start.
Dr. Michael Rosol, the Company’s Chief Medical Officer, said,
“This is a critical milestone in our RA program and for the Company
as a whole. Throughout this program’s development, we have worked
closely with expert rheumatologists and nuclear medicine
specialists, and we believe we are on the right path to bringing a
valuable tool to bear to meet a large unmet medical need in
patients with RA.” Dr. Rosol continued, “Success 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 is possible today.”
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
financial trends affecting the financial condition of our business.
Forward-looking statements include our expectations regarding
pending litigation and other matters. These forward-looking
statements are subject to a number of risks, uncertainties and
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
about the commercial success of the product, expected associated
costs, and the outcome of various risks, including the outcome of
clinical trials, that could affect the timetable for revenues,
among other assumptions, that actual outcomes are likely to vary
from such assumptions, resulting in variations from the possible
results set forth in the valuation report; 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
SEC filings, which are available at http://www.sec.gov or at
http://ir.navidea.com.
Investors are urged to consider statements that include the
words “will,” “may,” “could,” “should,” “plan,” “continue,”
“designed,” “goal,” “forecast,” “future,” “believe,” “intend,”
“expect,” “anticipate,” “estimate,” “project,” and similar
expressions, as well as the negatives of those words or other
comparable words, to be uncertain forward-looking statements.
You are cautioned not to place undue reliance on any
forward-looking statements, any of which could turn out to be
incorrect. We undertake no obligation to update publicly or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise after the date of this
report. In light of these risks and uncertainties, the
forward-looking events and circumstances discussed in this report
may not occur and actual results could differ materially from those
anticipated or implied in the forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211216006102/en/
Investor Relations Contact Navidea Biopharmaceuticals,
Inc. Jeffrey Smith Vice President of Operations 614-822-2365
jsmith@navidea.com
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Apr 2023 to Apr 2024