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Navidea Biopharmaceuticals Initiates Enrollment in Global Phase 3 Trial of NAV4694 PET Imaging Agent

  Navidea Biopharmaceuticals Initiates Enrollment in Global Phase 3 Trial of
  NAV4694 PET Imaging Agent

Business Wire

DUBLIN, Ohio -- June 27, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced the
first subject has been enrolled in its NAV4694 global, pivotal Phase 3
clinical trial. The trial will assess the safety and efficacy of NAV4694, an
investigational PET imaging agent, in detecting cerebral β-amyloid in
end-of-life subjects with and without the diagnosis of dementia. The study
will examine the effectiveness of NAV4694 in detecting the presence or absence
of β-amyloid deposition in the brain by directly correlating the PET image
findings during life with those of the brain tissue upon autopsy after death.

Currently, only an autopsy can confirm that a person has Alzheimer's disease.
“Knowing if a patient has Alzheimerʼs pathology in life would lead to improved
diagnosis and patient management,” said Frederick Cope, PhD, FACN, Senior Vice
President and Chief Scientific Officer at Navidea. “This study, which is
designed to provide a direct comparison of patient images collected during
life using a β-amyloid PET imaging agent with postmortem histopathology
findings, has the potential to aid the advancement of neurodegenerative
disease research and patient care.”

“We are excited to begin this pivotal Phase 3 trial for NAV4694. We believe
that β-amyloid imaging has the potential to play an increasingly important
role in clinical practice allowing for earlier diagnosis and therapeutic
intervention,” said Connie Reininger, MD, PhD, Navidea’s Senior Vice President
and Chief Medical Officer. “Results from earlier trials using NAV4694 support
our conviction that the outstanding performance characteristics of this
imaging biomarker, which include favorable sensitivity, specificity, rapid
brain uptake and improved image clarity due to low white-matter uptake,
position NAV4694 as a true ‘best-in-class’ second generation agent to aid in
the diagnosis of Alzheimer’s disease and with the potential to enable
diagnosis earlier in the course of disease.”

About the NAV4694 Phase 3 Clinical Trial

This study, NAV4-02, is a Phase 3, open-label, multiple-center, non-randomized
study to assess the safety and efficacy of NAV4694 PET imaging in detecting
cerebral β-amyloid in subjects during life when directly compared to brain
histopathological evaluation at autopsy. The trial will enroll up to 275
end-of-life individuals in two cohorts either, 1) subjects diagnosed with
probable Alzheimer’s disease or other form of dementia, or, 2) non-demented
volunteers. The efficacy of NAV4694 PET for the detection of β-amyloid will be
determined by the sensitivity and specificity of visual interpretation of
NAV4694 uptake in the PET scans by blinded readers compared with the
presence/absence of β-amyloid upon histopathological evaluation of the
respective postmortem brain specimen in each subject. To learn more see the
study listing on ClinicalTrials.gov
http://www.clinicaltrials.gov/ct2/show/NCT01886820?term=navidea&rank=3.

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 has an ongoing
NAV4694 Phase 2b trial in Mild Cognitive Impairment and a Phase 3 program for
NAV4694 in AD.

About Alzheimer’s

Alzheimer’s disease (AD) is a progressive and fatal neurodegenerative disease
which affects a person’s memory and ability to learn, reason, communicate and
carry out daily activities. Increasing age is the greatest risk factor for AD
and there is no prevention or cure. The World Health Organization estimates
that Alzheimer’s disease affects over 24 million people worldwide. Currently
in the U.S. alone, there are over 5 million Alzheimer’s patients with
estimates that by 2050, as many as 14 million Americans could have the disease
according to the Alzheimer’s Association. Among the brain changes believed to
contribute to the development of Alzheimer’s are the accumulation of the
protein β -amyloid outside nerve cells (neurons) in the brain and the
accumulation of the protein tau inside neurons. Approximately 75 to 100
experimental technologies aimed at diagnosing, slowing or stopping the
progression of Alzheimer’s are now in human clinical trials.

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
 
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