Navidea Biopharmaceuticals Announces Enrollment of First Subject in Phase 2b Trial of NAV4694 in Subjects with Mild Cognitive

  Navidea Biopharmaceuticals Announces Enrollment of First Subject in Phase 2b
  Trial of NAV4694 in Subjects with Mild Cognitive Impairment (MCI)

 - Study to evaluate NAV4694 in monitoring progression of MCI to Alzheimer’s
                                  Disease -

Business Wire

DUBLIN, Ohio -- March 27, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced that
enrollment has commenced in its Phase 2b, open-label, safety and efficacy
positron emission tomography (PET) imaging study of [^18F]NAV4694 for
detection of cerebral β-amyloid plaque in subjects diagnosed with Mild
Cognitive Impairment (MCI). The study is designed to investigate whether
NAV4694 positron emission tomography (PET) scan findings have the ability to
distinguish subjects with MCI who progress to Alzheimer’s disease (AD) from
those who do not. Enrollment is currently planned at approximately five sites
throughout the U.S. The first patient has been enrolled by the Alzheimer's
Disease Center at Quincy Medical Center in Quincy, MA.

“We are pleased to participate in this important clinical study of NAV4694
aimed at evaluating a patient population in whom dementia is just emerging and
for whom it is believed the best prospects for therapeutic intervention will
exist,” said Dr. Anil K. Nair, MD, Chief of Neurology and Head of the
Alzheimer's Disease Center at Quincy Medical Center in Quincy, MA. “Clinical
trial results to date indicate that NAV4694 shows favorable sensitivity and
specificity in detecting β-amyloid while exhibiting low white-matter uptake
for clearer images that may assist in differential diagnoses associated with
MCI. If AD could be diagnosed at an earlier stage, before clinical dementia
has fully developed, the potential for successful intervention with current
and future treatments could be improved considerably.”

“As the dementia field moves to earlier evaluation and treatment of cognitive
impairment, it is of increasing importance to have diagnostic agents that can
accurately detect the underlying cause. To our knowledge this is the first
prospective, multi-center study to evaluate a radiopharmaceutical β-amyloid
agent solely in subjects with MCI, an area of extreme importance as
Alzheimer's disease is expected to impact as many as 14 million Americans by
2050,” commented Cornelia Reininger, MD, PhD, Navidea’s Senior Vice President
and Chief Medical Officer. “The outcome of this trial may enable accurate
differentiation of MCI subjects who are at risk of developing Alzheimer’s
disease from those who are not before the disease has reached more advanced
stages that can impair activities of daily living. Our ultimate goal is to
provide an improved diagnostic tool with outstanding performance
characteristics for physicians to aid in the diagnosis of Alzheimer's disease
and other forms of neurodegenerative dementia.”

NAV4-04 is a Phase 2b, open-label, multiple-center, non-randomized, PET
imaging study to assess the safety and efficacy of NAV4694 in subjects
diagnosed with MCI to investigate whether NAV4694 PET scan findings have the
ability to distinguish subjects with MCI who progress to AD from those who do
not. In conjunction with neuro-cognitive testing examinations, subjects will
receive three injections of the investigational, diagnostic agent during a 36
month period: at baseline, 18 months and 36 months. Assessment of NAV4694
efficacy will be based on the sensitivity, specificity, and the negative and
positive predictive value of the NAV4694 PET scan findings in predicting
progression from MCI to AD over 36 months. The overall Standard of Truth
assessment as to cognitive state (e.g., cognitive decline and/or progression
to dementia) will be performed by an investigator who will be blinded to the
results of NAV4694 PET findings.

Information on the protocol and enrolling sites for this study (NAV4-04) can
be found at:
http://www.clinicaltrials.gov/ct2/show/NCT01812213?term=Navidea&rank=4.

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. Amyloid plaque pathology is standardly used in the
diagnosis of AD so the ability of NAV4694 combined with 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.

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 24,000,000 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 therapies 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
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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, Inc.
Brent Larson, 614-822-2330
Sr. VP & CFO
 
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