Navidea to Collaborate with University of California–San Francisco on Clinical Study Evaluating Manocept™ Platform Imaging

  Navidea to Collaborate with University of California–San Francisco on
  Clinical Study Evaluating Manocept™ Platform Imaging Agent in Kaposi Sarcoma
  (KS) Patients

        - Investigator-Initiated Study will evaluate KS lesions using
                   technetium-labeled tilmanocept imaging -

 - Supporting results from proof-of-concept study in KS tissue reported at an
                      international conference on AIDS -

Business Wire

DUBLIN, Ohio -- November 13, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced it will
collaborate with investigators at the University of California, San Francisco
(USCF), on a clinical study to evaluate, for the first time, the use and
performance of technetium–labeled tilmanocept in patients with Kaposi Sarcoma
(KS). The investigator–initiated study will evaluate HIV patients with various
stages of KS who will be administered ^99mTc-tilmanocept and assessed by SPECT
imaging for localization of KS lesions and possible identification of KS
disease spread. Co-primary investigators are Michael S. McGrath, MD, PhD,
Professor, Departments of Laboratory Medicine, Pathology, and Medicine, UCSF,
and Toby Maurer, MD, Dermatologist, UCSF Lakeshore Family Medicine Center.

“Kaposi sarcoma not only affects skin but in more advanced states involves
other organs and tissues, including lymph nodes. Attempts to confirm KS
involvement in other tissues to determine if and where the tumor has spread
have generally been problematic, so patient staging and treatment regimens may
not be optimally managed,” commented Dr. McGrath. “The receptor-targeting
properties and strong performance in malignancies such as melanoma and breast
cancer indicate that tilmanocept and other Manocept-derived agents which
specifically target the CD206 mannose receptor are potentially potent tools
for addressing unmet needs in this area such as identifying, staging and
assessing disease activity.”

Navidea also announced that results from a study of Kaposi sarcoma (KS)
tissue, using a novel fluorescent imaging agent from the Company’s Manocept™
Platform, were presented at the 14th International Conference on Malignancies
in AIDS and Other Acquired Immunodeficiencies (ICMAOI) by Dr. McGrath this
week at the National Institutes of Health in Bethesda, Maryland.

The study presentation, “Tilmanocept, a labeled ligand for macrophage mannose
receptor (CD206) may allow imaging of Kaposi’s sarcoma spindle cells and tumor
associated macrophages,”  was designed to assess the feasibility of a Manocept
imaging agent for specific KS tumor imaging. The results indicate that in 66
evaluable cases, the presence of CD206, the mannose receptor, was confirmed on
tumor-associated macrophages (TAMs) as well as a majority of KS tumor cells
and that CD206 was the most prevalent antigen for both KS tumor spindle cells
and TAMs. The authors concluded the results indicate that the agent may allow
effective imaging of KS involved tissues and nodes including potential
visceral sites of disease. Attributes of the fluorescent Cy3-tilmanocept agent
were recently presented in a special supplement to the journal Nature entitled
Nature Outlook: Medical Imaging.

“This conference presentation further emphasized the potential of our Manocept
platform into therapeutic areas where there is medical need for innovative
precision diagnostics in the quest for better patient outcomes,” said
Frederick Cope, PhD, FACN, Senior Vice President and Chief Scientific Officer
at Navidea. “These newly developed data suggest that our Manocept platform
represents an opportunity to exploit the CD206-targeting mechanism underlying
the robust, purpose-built drug design of our approved lymphatic mapping agent.
With the announcement of our exciting UCSF clinical collaboration, we intend
tocontinue to evaluateemerging data in KS and will further explore other
disease states to refine our areas of focus and capitalize on this innovative
platform."

About Navidea Biopharmaceuticals, Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical
company focused on the development and commercialization of precision
diagnostics and radiopharmaceutical agents. Navidea is developing multiple
precision diagnostic products and platforms including NAV4694, NAV5001,
Manocept™ and RIGScan^TM , to help identify the sites and pathways of
undetected disease and enable better diagnostic accuracy, clinical
decision-making and, ultimately, patient care. Lymphoseek^® (technetium 99m
tilmanocept) Injection, ^ Navidea’s first commercial product from the Manocept
platform, was approved by the FDA in March 2013. Navidea’s strategy is to
deliver superior growth and shareholder return by bringing to market novel
radiopharmaceutical agents and advancing the Company’s pipeline through
selective acquisitions, global partnering and commercialization efforts. For
more information, please visit www.navidea.com.

The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe
harbor for forward-looking statements made by or on behalf of the Company.
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deficit, future capital needs, uncertainty of capital funding, dependence on
limited product line and distribution channels, competition, limited marketing
and manufacturing experience, risks of development of new products, regulatory
risks and other risks detailed in the Company’s most recent Annual Report on
Form 10-K and other Securities and Exchange Commission filings. The Company
undertakes no obligation to publicly update or revise any forward-looking
statements.

Contact:

Navidea Biopharmaceuticals
Brent Larson, 614-822-2330
Executive VP & CFO
or
Sharon Correia, 978-655-2686
Associate Director, Corporate Communications
 
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