Navidea Announces Presentations Highlighting NAV4694 Beta-Amyloid, PET Imaging Agent at the German Society of Nuclear Medicin...
March 26 2014 - 7:30AM
Business Wire
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced that collaborators from the
Department of Nuclear Medicine at University Hospital of Leipzig
plan presentations highlighting Navidea’s PET imaging agent,
NAV4694, at the German Society of Nuclear Medicine Annual Congress
in Hannover, Germany, March 26-29, 2014. NAV4694 is an
investigational Fluorine-18 labeled beta-amyloid imaging agent
currently being evaluated in late stage clinical trials for use as
an aid in differential diagnosis and to monitor progression of
Alzheimer's disease (AD), Mild Cognitive Impairment (MCI) and other
forms of neurodegenerative dementia.
On March 27, Osama Sabri, MD, PhD, Professor of Nuclear
Medicine, Chairman and Director of the Department of Nuclear
Medicine of the University of Leipzig, Germany, and President of
the SNMMI Brain Imaging Council is presenting the plenary Wolfgang
Becker Memorial Lecture entitled “Modern Nuclear Medical Diagnostic
Methods in Dementia” in which NAV4694 images and results will be
highlighted. “As the dementia field strives for earlier evaluation
and treatment of cognitive impairment, it is of increasing
importance to have diagnostic agents that can accurately assess
patient status. Through our collaborative work with Navidea, we
have been impressed with the clarity of patient diagnostic images
using NAV4694 allowing easy interpretation and differentiation into
amyloid-positive or amyloid-negative categories,” said Dr. Sabri.
“I and my colleagues are pleased to present this information to the
European nuclear medicine community.”
“We are delighted that our collaborators at the Leipzig
University have shared these data with the medical community at the
German Society of Nuclear Medicine. These results add to our
conviction that NAV4694, with its inherent performance
characteristics, may afford new opportunities to advance the early
diagnosis of cognitive decline, including MCI,” said Cornelia
Reininger, MD, PhD, Navidea’s Senior Vice President and Chief
Medical Officer. “We remain committed to providing physicians and
patients an improved PET-diagnostic agent that can aid in the
differential diagnosis of Alzheimer's disease and other forms of
neurodegenerative dementia.”
Also on March 27, during the Dementia session, Dr. Henryk
Barthel, MD, PhD, Assistant Medical Director Neuro-PET and PET-MRI,
Department of Nuclear Medicine, University Hospital Leipzig is
presenting “β-Amyloid PET Tracer 18F-NAV4694: White Matter
Influence on Detectability of Brain Amyloid,” which concludes that
evaluation of NAV4694 PET scans and MRI data from 20 patients (10
AD, 10 age-matched HV) showed lower white matter uptake of NAV4694
compared with other 18F amyloid radiotracers, meaning that white
matter contribution to measurements is less and may provide better
sensitivity for detecting within-subject changes.
About NAV4694NAV4694 is an investigational 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 beta-amyloid deposits in
the brain that can then be imaged in scans. Beta-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 has a
Phase 2b study underway in MCI and a Phase 3 program in AD
underway.
About Navidea BiopharmaceuticalsNavidea
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 NAV1800 (RIGScan™), 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. 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.
Navidea BiopharmaceuticalsBrent Larson, Executive VP & CFO,
614-822-2330
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