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Navidea Biopharmaceuticals Announces Comparative Study to Evaluate the Potential Utility of Tilmanocept In Patients with Tuberculosis ("TB")

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  • New comparative study of 68Ga-Tilmanocept and 18F-FDG PET/CT in the
    evaluation of patients with TB
  • Purpose to evaluate the use of 68Ga-Tilmanocept as a probe to locate
    macrophage mannose receptor ("MR," CD206) within TB granulomas

Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the
"Company"), a company focused on the development of precision
immunodiagnostic agents and immunotherapeutics, today announced that
Professor Mike Sathekge, MBChB, M. Med (Nuclear Medicine), PhD Professor
and Head of the Department of Nuclear Medicine in the Faculty of Health
Sciences at the University of Pretoria/Steve Biko Academic Hospital,
plans to initiate a comparative study evaluating the use of Tilmanocept
in patients with TB.

Relevance of the Study

The purpose of the study is to explore using 68Ga-Tilmanocept as an aid
in TB patient management while contributing to the better understanding
of the biology of TB granulomas. The TB granuloma plays multiple roles
in tuberculous infection, although much remains unknown about its
biology. Macrophages constitute one of the most abundant cell types in
the TB granuloma. A molecular probe such as 68Ga-labeled Tilmanocept
targeting MR (CD206) expressed on macrophages, therefore, holds great
promise not only in understanding the behavior of TB granulomas, but may
serve as a vehicle for delivering therapeutic interventions in the
future. Comparing findings on 68Ga Tilmanocept PET/CT and FDG PET/CT
will contribute to the understanding of the biology of tuberculous
granuloma. Navidea would provide tilmanocept for use in this study.
Successful completion of this study could lead to an extended claim of
68Ga-Tilmanocept.

Principal Investigator

Professor Mike Sathekge, Principal Investigator of this study, said,
"Our collaboration with Navidea promises to make pivotal contributions
to the biology of the tuberculous granuloma and the development of novel
targeted therapeutic interventions."

Dr. Michael Rosol, Chief Medical Officer of Navidea, said, "We are
excited to begin this comparative study in collaboration with the
Department of Nuclear Medicine at the University of Pretoria. We look
forward to providing updates on this study in the near future."

"As the worldwide community further embraces TB treatments and screening
to prevent the spread of the disease, we are very pleased to begin this
comparative study," said Jed Latkin, Chief Executive Officer of Navidea.
"This is an exciting milestone of innovation and continued progress for
Navidea."

Latest Statistics on the TB Epidemic

TB is the most infectious killer worldwide and is also the leading cause
of death among people diagnosed with HIV. In terms of TB care and
prevention, TB treatments saved fifty-four million lives worldwide from
2000-2017.1

Worldwide, TB is one of the top 10 causes of death and the leading cause
from a single infectious agent (above HIV/AIDS). Millions of people
continue to fall sick with TB each year. In 2017, TB caused an estimated
1.3 million deaths (range, 1.2–1.4 million) among HIV-negative people
and there were an additional 300 000 deaths from TB (range,
266 000–335 000) among HIV-positive people. Globally, the best estimate
is that 10.0 million people (range, 9.0–11.1 million) developed TB
disease in 2017: 5.8 million men, 3.2 million women and 1.0 million
children. There were cases in all countries and age groups, but overall
90% were adults (aged ≥15 years), 9% were people living with HIV (72% in
Africa) and two thirds were in eight countries: India (27%), China (9%),
Indonesia (8%), the Philippines (6%), Pakistan (5%), Nigeria (4%),
Bangladesh (4%) and South Africa (3%). These and 22 other countries in
WHO's list of 30 high TB burden countries accounted for 87% of the
world's cases. Only 6% of global cases were in the WHO European Region
(3%) and WHO Region of the Americas (3%). The severity of national
epidemics varies widely among countries. In 2017, there were fewer than
10 new cases per 100 000 population in most high-income countries,
150–400 in most of the 30 high TB burden countries, and above 500 in a
few countries including Mozambique, the Philippines and South Africa.
Drug-resistant TB continues to be a public health crisis. The best
estimate is that, worldwide in 2017, 558 000 people (range,
483 000–639 000) developed TB that was resistant to rifampicin (RR-TB),
the most effective firstline drug, and of these, 82% had
multidrug-resistant TB (MDR-TB). Three countries accounted for almost
half of the world's cases of MDR/RR-TB: India (24%), China (13%) and the
Russian Federation (10%).2

References

1). https://www.who.int/tb/publications/factsheet_global.pdf?ua=

2). https://www.who.int/tb/publications/global_report/tb18_ExecSum_web_4Oct18.pdf?ua=1

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE: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. The development
activities of the Manocept immunotherapeutic platform are being
conducted by Navidea in conjunction with its subsidiary, Macrophage
Therapeutics, Inc. Navidea's strategy is to deliver superior growth and
stockholder 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 release and any oral statements made with respect to the
information contained in this 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.
These forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including, among other things: any future
actions by Platinum-Montaur; general economic and business conditions,
both nationally and in our markets; our history of 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; our expectations and
estimates concerning future financial performance, financing plans and
the impact of competition; our ability to raise capital sufficient to
fund our development and commercialization programs; our ability to
implement our growth strategy; anticipated trends in our business;
advances in technologies; our ability to comply with the NYSE American
continued listing standards; our ability to maintain effective internal
control over financial reporting; 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 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
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You are cautioned not to place undue reliance on any forward-looking
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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
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anticipated or implied in the forward-looking statements.

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