Navidea Biopharmaceuticals Announces that Results of NAV4694 Clinical Trial Published in the Journal of Nuclear Medicine

  Navidea Biopharmaceuticals Announces that Results of NAV4694 Clinical Trial
  Published in the Journal of Nuclear Medicine

 - Head-to-head comparison of NAV4694 and β-Amyloid imaging gold standard in
                      Alzheimer’s disease and dementia -

Business Wire

DUBLIN, Ohio -- April 18, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced the
peer-reviewed publication of results from a clinical trial of NAV4694 in
healthy subjects and those with diagnosed forms of dementia. The trial
assessed the performance of Navidea’s Fluorine-18 labeled amyloid imaging
candidate, NAV4694, in a head-to-head comparison with the acknowledged
benchmark, gold-standard amyloid imaging agent, ^11C-labeled Pittsburgh
Compound-B ^ (PiB). Results demonstrated that NAV4694 displayed imaging
characteristics nearly identical to those of PiB and the authors believe these
results show that NAV4694 may be useful in the early and differential
diagnosis of Alzheimer’s disease (AD). The study, “Head-to-Head Comparison of
^11C-PiB and ^18F-AZD4694 (NAV4694) for β-Amyloid Imaging in Aging and
Dementia,” was published in the current online edition of the Journal of
Nuclear Medicine and will appear in the June print edition [J Nucl Med 2013;
54:1–7 DOI: 10.2967/jnumed.112.114785].

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. “For this to be a reality,
clinicians will need access to reliable, practical and affordable imaging
options,” said Professor Christopher Rowe, MD, FRACP, Director of the
Department of Nuclear Medicine and Centre for PET at Austin Health, Melbourne,
Australia and one of the authors. ”This study suggests that NAV4694 images may
be more easily and reliably read in clinical practice than other F-18 labeled
PET tracers. By displaying imaging characteristics nearly identical to those
of the gold standard, PiB, NAV4694 provides the same low background needed for
earlier differential diagnosis while affording the practicality needed for
production logistics.”

“With the ongoing movement toward earlier evaluation and treatment of
cognitive impairment, it is of increasing importance for an improved
diagnostic tool that can identify clinical dementia and cognitive impairment
before it has fully developed,” commented Cornelia Reininger, MD, PhD,
Navidea’s Senior Vice President and Chief Medical Officer. “These results add
to our conviction that NAV4694, with its outstanding performance
characteristics, may afford new opportunities to advance the early diagnosis
of cognitive decline. We are very excited about the recent initiation of our
Phase 2b study evaluating NAV4694 in the differentiation of Mild Cognitively
Impaired (MCI) subjects who are at risk of developing Alzheimer’s disease from
those who are not, enabling the potential for early intervention with current
and future treatments.”

About the NAV4694 Head-to-Head Comparison Clinical Trial and Results

Forty-five participants (25 healthy elderly controls (HC), 10 with Mild
Cognitive Impairment (MCI), 7 with AD and 3 with fronto-temporal dementia)
underwent PET imaging with both PiB and NAV4694 imaging agents. The PiB and
NAV4694 images were virtually indistinguishable by visual inspection and
similarly low to no white matter binding was observed with both radiotracers.
Low white matter binding coupled with comparatively high binding to target
amyloid provide enhanced signal-to-noise ratios, facilitating detection of
lower levels of amyloid. This may enable earlier detection of amyloid and
therefore earlier diagnosis of the underlying cause of cognitive impairment
and dementia. When quantified, there were no significant differences in white
matter binding for each tracer in both healthy controls and dementia subjects.
The quantitative measures of NAV4694 binding to cortical amyloid plaques
showed almost identical results to PIB. There was an excellent linear
correlation between PiB and NAV4694 neocortical standardized uptake value
ratios, or SUVR, (slope of 0.95, r = 0.99, P < 0.0001). Both radiotracers
showed similar binding kinetics and dynamic range. As expected, the AD group
showed higher β-Amyloid detection than the HCs, as measured by both PiB and
NAV4694 binding, and provided a robust separation of AD patients from HCs. Of
note, the authors state that visually, 16% of the Healthy Controls were deemed
positive for β-Amyloid as assessed by both PiB and NAV4694, presenting an
almost identical pattern of binding suggesting that β-Amyloid deposition is an
early feature of the disease preceding cognitive impairment. No serious
adverse events related to the study drugs were observed or reported by any
participants as a result of the PiB or NAV4694 scans, and no concerns were
raised by the participants or their relatives.

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.

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 pharmaceuticals 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.
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of the date hereof. Investors are cautioned that such statements involve risks
and uncertainties that could cause actual results to differ materially from
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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:

Investors:
Navidea Biopharmaceuticals, Inc.
Brent Larson, Sr. VP & CFO
614-822-2330
 
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