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Navidea Biopharmaceuticals Presents New Data on Precision Diagnostic Platform at Harvard Conference

  Navidea Biopharmaceuticals Presents New Data on Precision Diagnostic
  Platform at Harvard Conference

- Proof-of-principle data marks expansion of the Navidea Manocept™ platform -

    - Company executives discuss precision diagnostics in panel sessions -

Cancer Advance Conference 2013

Business Wire

DUBLIN, Ohio -- September 19, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, presented collaborative
data at the Cancer Advance Conference at Harvard Medical School from
proof-of-principle imaging studies using tilmanocept-Cy3, a
fluorescent-labeled agent from the Company’s Manocept™ platform, utilizing
technical principle underlying Navidea’s FDA-approved lymphatic mapping
product, Lymphoseek^® (technetium 99m tilmanocept) Injection. Data presented
at the conference establish the feasibility of using Manocept compounds to
bind to the CD206 mannose receptor and target macrophage inflammatory cells,
an approach that may enable the design of novel immune cell-targeted agents
for diagnosis and disease staging.

These studies using human tissue, animal model and in vitro analyses focused
on establishing the ability of fluorescent tilmanocept-Cy3 to target
macrophages in two disease states which are representative of broader
macrophage-associated disorders: Kaposi’s Sarcoma (KS) and Tuberculosis (TB),
both outside the current lymphatic mapping application. These data support the
expansion of the Manocept platform into potential new indications in
macrophage-mediated disorders, utilizing immune-cell targeting to address
unmet diagnostic needs in this emerging area. Other recognized
macrophage-mediated disorders include not only KS and TB, but rheumatoid
arthritis, Systemic Lupus Erythematosis, atherosclerosis/vulnerable plaque,
Crohn’s disease and others that span clinical areas in oncology, autoimmunity,
infectious diseases, cardiology, and inflammation.

“Today’s conference emphasized the medical need for innovative precision
diagnostics in the pursuit of better patient outcomes in a range of diseases,”
commented Dr. Mark Pykett, Navidea CEO. “With the US approval and
commercialization of our Lymphoseek product using CD206-targeting technology,
we believe now is an opportune time to unveil the extension of our platform to
promising new areas. These newly developed data suggest that our Manocept
platform represents an opportunity to exploit the CD206-targeting mechanism
underlying Lymphoseek and focus on new areas of diagnostic need beyond
lymphatic mapping. We are encouraged by these data, provided by key experts in
the field, supporting this principle. We intend tocontinue to
evaluateemerging data in other disease states to define areas of focus,
development pathways and partnering options to capitalize on this innovative
platform," added Dr. Pykett.

The Manocept Platform

Navidea’s Manocept platform is predicated on the ability to specifically
target the CD206 mannose receptor expressed on macrophages. Macrophages play
important roles in many disease states and are an emerging target in many
diseases where diagnostic uncertainty exists. This flexible and versatile
platform acts as an engine for purpose-built molecules that may enhance
diagnostic accuracy, clinical decision-making and ultimately patient care,
while offering the potential to utilize a breadth of diagnostic modalities,
including SPECT, PET, intra-operative and/or optical-fluorescence detection.
The Company’s FDA-approved precision diagnostic lymphatic mapping agent,
Lymphoseek (technetium 99m tilmanocept) Injection, is representative of the
ability to successfully exploit this mechanism to develop powerful, new
diagnostic agents.

Data presented at the Harvard Conference focused on proof-of-principle studies
in KS and TB. “With increased retroviral treatment resistance, the incidence
of Kaposi Sarcoma appears to be growing, with the disease extending to other
organs and tissues beyond skin. Unfortunately, there are few, if any,
tumor-specific diagnostic options to determine if and where the tumor has
spread from the skin, so patient staging and treatment regimens may not be
optimally managed,” commented Michael S. McGrath, MD, PhD, Professor,
Departments of Laboratory Medicine, Pathology, and Medicine, University of
California, San Francisco. “Having conducted research in macrophage-mediated
disease pathogenesis for decades, I believe that CD206 targeting in general,
and Manocept-derived molecules in particular, are potentially potent tools for
addressing unmet needs in this area such as identifying, staging and assessing
disease activity, and represents a platform that may be able to address
broader disease states where macrophages are known to play a role.”

The poster presentation entitled “Targeting the Human Mannose Receptor (CD206)
for Lesion Localization and Imaging in Kaposi’s Sarcoma and Other Disorders”
highlights research from the labs of Navidea collaborators Dr. Michael McGrath
of UCSF and Drs. Larry Schlesinger and Wael Jarjour of The Ohio State
University. The studies evaluated the ability of tilmanocept-Cy3, a
CD206-targeted imaging agent, to identify and localize specifically to
macrophage CD206. Data presented included findings in KS studies that
tilmanocept-Cy3 binds specifically to and localizes macrophage CD206 in KS
lesions. In tumor tissue from over 60 KS patients, greater than 96% of KS
tumor cells and tumor-associated macrophages expressed CD206 and bound and
internalized tilmanocept-Cy3, affording a precise means of identifying these
cells in KS lesions.

Data from an additional study in TB demonstrated similar binding and
internalization in macrophages infected with M. tuberculosis, the causative
mycobacterium in tuberculosis. These data suggest that the ability to target
CD206 and identify disease-associated macrophages may potentially be broadly
applicable in the development of new diagnostics. Additional data are
currently being developed in rheumatoid arthritis. The Company anticipates
publication ofManocept data in the coming weeks.

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 actively developing
four radiopharmaceutical agent platforms – Lymphoseek^® (technetium 99m
tilmanocept) Injection, NAV4694, NAV5001 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. Navidea’s
first commercial agent, Lymphoseek, ^ 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.

About Lymphoseek®

Lymphoseek^® (technetium Tc 99m tilmanocept) Injection is a novel,
receptor-targeted, small-molecule radiopharmaceutical used in lymphatic
mapping procedures that are performed to help in the diagnostic evaluation of
potential cancer spread for patients with breast cancer and melanoma.
Lymphoseek is designed to identify the lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer. Lymphoseek was
approved by the U.S. Food and Drug Administration in March, 2013 for use in
lymphatic mapping to assist in the localization of lymph nodes draining a
primary tumor in patients with breast cancer or melanoma. The Company
anticipates continuing development of Lymphoseek into other solid tumor areas
that may include head and neck cancers, prostate cancer, thyroid cancer,
lung/bronchus cancers, colorectal cancer and others.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy
decisions and determines patient prognosis and risk of recurrence. According
to the American Cancer Society, approximately 232,000 new cases of breast
cancer, 77,000 new cases of melanoma and 67,000 new cases of head and
neck/oral cancer are expected to be diagnosed in the United States in 2013.

U.S. Indication and Important Safety Information About Lymphoseek

Indication

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a lymphatic mapping
agent indicated for use with a hand-held gamma counter to assist in the
localization of lymph nodes draining a primary tumor site in patients with
breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were
reported, however Lymphoseek may pose a risk of such reactions due to its
chemical similarity to dextran. Serious hypersensitivity reactions have been
associated with dextran and modified forms of dextran (such as iron dextran
drugs).

Prior to the administration of Lymphoseek, patients should be asked about
previous hypersensitivity reactions to drugs, in particular dextran and
modified forms of dextran. Resuscitation equipment and trained personnel
should be available at the time of Lymphoseek administration, and patients
observed for signs or symptoms of hypersensitivity following injection.

The most common adverse reactions are injection site irritation and/or pain
(<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:

WWW.LYMPHOSEEK.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.
Statements in this news release, which relate to other than strictly
historical facts, such as statements about the Company’s plans and strategies,
expectations for future financial performance, new and existing products and
technologies, anticipated clinical and regulatory pathways, and markets for
the Company’s products are forward-looking statements within the meaning of
the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,”
and similar expressions identify forward-looking statements that speak only as
of the date hereof. Investors are cautioned that such statements involve risks
and uncertainties that could cause actual results to differ materially from
historical or anticipated results due to many factors including, but not
limited to, the Company’s continuing operating losses, uncertainty of market
acceptance of its products, reliance on third party manufacturers, accumulated
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
Stern Investor Relations, Inc.
Beth DelGiacco, 212-362-1200
 
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