Navidea Announces Data Presentations at 2013 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI)

  Navidea Announces Data Presentations at 2013 Annual Meeting of the Society
  of Nuclear Medicine and Molecular Imaging (SNMMI)

   ‒ Fourteen presentations highlight results from Lymphoseek^® and NAV4694
                              clinical trials ‒

Business Wire

DUBLIN, Ohio -- June 4, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced that
data from its Lymphoseek^® (technetium Tc 99m tilmanocept) Injection and
NAV4694 studies are being presented at the 2013 Annual Meeting of the Society
of Nuclear Medicine and Molecular Imaging (SNMMI) to be held June 8-12, 2013
in Vancouver, Canada. In addition to the ten oral and poster presentations
highlighting both the comparative performance of Lymphoseek against
commonly-used non-receptor targeted colloidal materials as well as the results
demonstrating the efficacy of lymphatic mapping in breast, melanoma and head
and neck cancers, there will also be four oral and poster presentations
focused on Navidea’s β-amyloid PET imaging agent, NAV4694, that will reveal
performance and comparative results from clinical studies in Alzheimer’s
disease.

“We are honored to have these data showcased at the world’s premier
educational and networking event for molecular imaging and nuclear medicine.
These peer-reviewed presentations represent the growing body of clinical
experience supporting both our recently launched lymphatic mapping agent,
Lymphoseek, and the potential of NAV4694 as a diagnostic aid in Alzheimer’s
disease and cognitive impairment,” said Dr. Mark Pykett, CEO of Navidea. “We
are proud to have what we believe is the deepest late-stage
radiopharmaceutical pipeline in the industry and remain committed to
developing precision diagnostics that help identify the presence and status of
disease enabling better diagnostic accuracy, clinical decision-making and
ultimately patient care.”

Notable data from Navidea and its collaborators being presented at SNMMI 2013
include:

Lymphoseek (tilmanocept)

                            99m Tc]Tilmanocept identifies more positive nodes
Presentation Title:     using fewer sentinel lymph nodes compared to
                            [99mTc] sulfur colloid in early stage breast
                            cancer patients
Author:                     Jennifer Baker, MD, Surgery, University of
                            California San Diego et al
                            
                            Receptor-seeking near-infrared radiopharmaceutical
Poster Title:               IRDye800CW - tilmanocept for multi-modality
                            sentinel lymph node imaging
Author:                     Zhengtao Qin, PhD, Department of Chemistry,
                            University of California San Diego et al
                            
                            Comparison of key sentinel node biopsy parameters
Presentation Title:         for 99mTc-tilmanocept (TcTM) and 99mTc-sulfur
                            colloid (TcSC) in breast cancer
Author:                     Stephen Povoski, MD, Ohio State University Wexner
                            Medical Center et al
                            
                            Intraoperative lymphatic mapping efficacy of
Presentation Title:         99mTc-tilmanocept (TcTM) does not change over time
                            post-injection relative to time of surgery
Author:                     James O’Donnell, MD, Case Western University
                            Hospitals et al
                            
                            Comparison of key sentinel node biopsy parameters
Poster Title:               for 99mTc-tilmanocept and 99mTc-sulfur colloid in
                            melanoma
Author:                     Vernon Sondak, MD, H. Lee Moffitt Cancer Center et
                            al
                            
                            Dynamic SPECT/CT quantification of sentinel lymph
Poster Title:               node uptake & injection site clearance (ISC):
                            Pilot study in intraoperative lymphatic mapping
                            for breast cancer
Author:                     Nathan C. Hall, MD PhD, The Ohio State University
                            et al
                            
Poster Title:               Bone marrow time-activity curves of
                            [68Ga]-tilmanocept exhibit molar dose-dependency
Author:                     Carl Hoh, MD, Radiology, University of California
                            San Diego et al
                            
Presentation Title:         Sentinel lymph node mapping via fluorescence
                            imaging of a multi-modal receptor-binding probe
Author:                     David Vera, PhD, UCSD and UCSD InVivo Cancer and
                            Molecular Imaging et al
                            
Presentation Title:         Dynamics of 99mTc-tilmanocept in intraoperative
                            lymphatic mapping
Author:                     Frederick Cope, PhD, Navidea Biopharmaceuticals,
                            Inc. et al
                            
                            Comparison of false negative rate (FNR) & overall
                            accuracy (AC) of sentinel lymph node biopsy (SLNB)
Presentation Title:         in phase 3 99mTc-tilmanocept (TcTM) vs ACOSOG
                            Z-0360 99mTc-sulfur colloid (TcSC) in head/neck
                            squamous cell cancer (SCC)
Author:                     Francisco J. Civantos, MD, FACS, University of
                            Miami Cancer Center et al
                            
NAV4694
                            
                            Emerging Technologies Session: Neurodegenerative
Presentation Title:         Imaging

                            NAV4694: A PET Biomarker for Brain Amyloid
Author:                     Connie Reininger, MD, PhD, Navidea
                            Biopharmaceuticals, Inc.
                            
Presentation Title:         Visual and semiquantitative validation of early
                            and late Aβ imaging approaches using 18F-NAV4694
Author:                     Christopher Rowe, PhD, Centre for PET, Austin
                            Health, Melbourne, Australia et al
                            
                            White matter segmentation analyses for assessing
Poster Title:               cortical SUVr in Alzheimer's using the novel PET
                            amyloid tracer 18F NAV4694
Author:                     John Seibyl, MD, Institute for Neurodegenerative
                            Disorders et al
                            
                            Effect of ligand mass dose on binding of the
Poster Title:               β-amyloid specific radioligand [18F]AZD4694
                            (NAV4694)
Author:                     Zsolt Cselényi, PhD, Karolinska Institutet,
                            AstraZeneca Translational Science Center et al
                            

Full session details, data presentation listings and abstracts at SNMMI can be
found through the Annual Meeting website at
http://interactive.snm.org/index.cfm?pageID=12252.

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.

About NAV4694

NAV4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate
intended for use in Positron Emission Tomography (PET) imaging and evaluation
of patients with signs or symptoms of cognitive impairment such as Alzheimer’s
disease (AD). NAV4694 binds to β-Amyloid deposits in the brain that can then
be imaged in scans. β-Amyloid plaque pathology is widely used in the diagnosis
of AD. The ability of NAV4694 imaging to display amyloid plaque pathology may
enable earlier identification of AD and improve monitoring of disease
progression and interpretation of brain scan images. Navidea plans for a Phase
3 trial of NAV4694 to begin in 2013.

AD is a progressive and fatal neurodegenerative disease. β-Amyloid imaging has
the potential to play an increasingly important role in clinical practice as
revised criteria for the diagnosis of probable AD allow for earlier diagnosis
and therapeutic intervention. Alzheimer’s Disease International estimated in
2010 that there were 36 million people living with all forms of dementia
including AD.

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^®, 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 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.
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
 
Press spacebar to pause and continue. Press esc to stop.