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 granting of a National Institutes of Health (“NIH”)
award to the University of California San Diego School of Medicine
for the proposal entitled, “Renal Molecular Imaging of Mesangial
Cell Function with Tc-99m-Tilmanocept.” The award (Project Number:
1R01DK127201-01), from the National Institute of Diabetes and
Digestive and Kidney Diseases of the NIH, was granted to
Co-Principal Investigators UC San Diego faculty Carl Hoh, MD and
David Vera, PhD, of the Department of Radiology, and Charles
Ginsberg, MD, MAS, of the Department of Medicine, Division of
Nephrology.
The worldwide prevalence of diabetes is expected to increase to
642 million within two decades. Approximately 40% of people with
diabetes will go on to develop diabetic nephropathy (“DN”) – a form
of chronic kidney disease (“CKD”). Typically, diabetic nephropathy
develops relatively slowly over the course of decades, as indicated
by slow increases in certain serum and urine markers over time. The
current standard-of-care for monitoring the development of CKD is
periodic assessment of these aforementioned markers. However,
twenty percent of diabetic patients who develop CKD experience a
more rapid development of DN. Consequently, there is an unmet
medical need for routine surveillance during the first decade of
CKD.
In this Phase 1 clinical study being conducted at UC San Diego
Health, Tc99m tilmanocept will be used as an imaging agent to
evaluate a key component of the kidneys, the mesangial cells, as a
biomarker for diabetic nephropathy. The molecular target for Tc99m
tilmanocept, CD206, is expressed on these mesangial cells of the
kidney. The expansion of mesangial cells is an early hallmark of
diabetic nephropathy, and the ability to reliably image them
noninvasively could provide an important tool for physicians to
evaluate diabetic patients for early signs of the disease.
This trial will be an open-label study investigating the
biodistribution at two dose levels (2.0 and 20 nmol) of Tc99m
tilmanocept. Four groups of patients at each dose (10 subjects
each), will be studied: 1) No CKD, 2) early CKD, 3) moderate CKD,
and 4) advanced CKD. Within each group, 50% of participants will
have diabetes. Expected results include kidney image sets and
biodistribution of Tc99m tilmanocept that reflects pathology. This
study is a necessary step toward FDA approval of Tc99m tilmanocept
as a kidney imaging agent.
From the proposal’s Public Health Relevance Statement: “This
proposal will use kidney SPECT/CT of Tc-99m-tilmanocept to evaluate
the mesangial changes seen in diabetics across the spectrum of
kidney disease as well as persons with hypertensive kidney disease,
the next most common cause of kidney disease in patients with
diabetes. We aim to demonstrate that these different disease types
and stages can be differentiated with Tc-99m-tilmanocept SPECT/CT
and can thus be used for future trials evaluating early diagnosis
and treatment of diabetic nephropathy.”
Dr. David Vera, Co-Principal Investigator, said, “Our goal is a
simple ‘first-line’ diagnostic tool for nephrologists to determine
which of their patients with diabetes are at risk of chronic kidney
disease.” Dr. Hoh added, “an additional potential benefit to a
Tc-99m-tilmanocept kidney imaging study may be an additional
modality for screening of renal cancer.” Dr. Ginsberg stated,
“considering the increasing armament of drugs to combat diabetic
nephropathy, an imaging study that can diagnose this disease early
in its course has tremendous therapeutic implications.”
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We
are pleased that the NIH has funded this important Phase 1 study at
UC San Diego, run in part by the inventor of tilmanocept, Dr. David
Vera.” Dr. Rosol continued, “Navidea has had a long and productive
relationship with Dr. Vera and his collaborators at UC San Diego,
and we will be keenly watching for the results of this study
addressing this area of large unmet clinical need. Today’s
announcement exemplifies the broad reach of our tilmanocept
platform. The development pipeline remains robust and we are
excited to continue developing new and valuable applications for
our core technology.”
Dr. Vera, together with Drs Anne Wallace and Carl Hoh, developed
Tc99m tilmanocept at UC San Diego Moores Cancer Center as an agent
to help detect and map cancers that have reached the lymph nodes.
Cancer clinical trials showed that it better detected cancer and
provided more accurate staging.
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.
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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
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Navidea Biopharmaceuticals, Inc. Jed Latkin Chief Executive
Officer 614-973-7490 jlatkin@navidea.com
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