- Phase 3 Studies to Evaluate the Use of
NAV5001 as an aid in the differential diagnosis of Parkinsonian
Syndromes from non-Parkinsonian tremor -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced the first subject has been
enrolled in one of the two planned NAV5001, pivotal Phase 3
clinical trials. The trial will assess the safety and efficacy of
NAV5001, an investigational imaging agent as an aid in the
differential diagnosis of Parkinsonian Syndromes from
non-Parkinsonian tremor. NAV5001 is an investigational imaging
agent used to visualize dopamine transporter protein (DAT) located
on the nigrostriatal neurons in the brain using single photon
emission tomography (SPECT) imaging. Loss of these neurons is a
widely recognized hallmark of Parkinson’s disease and other forms
of Parkinsonism.
“Reducing diagnostic uncertainty and error rates for patients
with movement disorders who often exhibit similar clinical symptoms
would afford great value, especially early in the initial clinical
presentation, and may lead to improved clinical decision-making and
patient management,” said Ira Goodman, MD, Principle Investigator,
Compass Research, LLC, Orlando, FL. “We look forward to evaluating
the attributes of NAV5001 as, unlike other agents, its rapid
kinetics indicate that we can scan patients very quickly following
injection. This is beneficial both for elderly patients and other
patients displaying movement symptoms, as well as providing an
avenue toward enhanced efficiency, productivity and patient
management in the clinic.”
“We are excited to begin this pivotal Phase 3 trial for NAV5001.
We believe that NAV5001 has the potential to play an important role
in clinical practice where physicians often struggle with the
differential diagnosis of movement disorders and tremors such as
are present in Parkinson’s disease,” said Cornelia Reininger, MD,
PhD, Navidea’s Senior Vice President and Chief Medical Officer.
“This registration program will focus on patients with emerging
symptoms in whom diagnostic uncertainty and unmet need are highest.
Results from earlier trials using NAV5001 suggest that it may be an
effective, well-tolerated imaging agent. The high affinity for DAT
with resulting clear images can assist physicians in reaching an
accurate diagnosis sooner, and the rapid kinetics with minimal time
between injection and scanning and time in the SPECT scanner not
only decrease patient exposure and but also facilitate increased
efficiency with potential cost savings for the nuclear medicine
facility.”
About the NAV5001 Phase 3 Clinical ProgramThe open-label,
pivotal NAV5001 Phase 3 program consists of two similar clinical
trials that will run in parallel and enroll approximately 550 total
subjects who exhibit early stage tremor. Each Phase 3 trial was the
subject of a special protocol assessment (SPA) agreement with FDA.
The primary endpoint of both studies is to evaluate the relative
diagnostic efficacy of the NAV5001 SPECT images compared with the
diagnosis made by neurologists and that established by a consensus
panel of three movement disorder specialists as the ‘Standard of
Truth’. In one study, each subject will undergo SPECT imaging with
NAV5001 only. In the second study, subjects will undergo SPECT
imaging with both NAV5001 and an alternative SPECT agent,
ioflupane, in a cross-over comparison design. To learn more, see
this study listing on ClinicalTrials.gov:
http://www.clinicaltrial.gov/ct2/show/NCT01950455?term=NAV5001&rank=1
About NAV5001Iodine-123 labeled NAV5001 is a patented,
novel, small molecule radiopharmaceutical used with single photon
emission computed tomography (SPECT) imaging to identify the status
of specific regions in the brains of patients suspected of having
Parkinson’s disease. The agent binds to the dopamine transporter
(DAT) on the cell surface of dopaminergic neurons in the striatum
and substantia nigra regions of the brain. Loss of these neurons is
a widely recognized hallmark of Parkinson’s disease and other forms
of Parkinsonism.
NAV5001 has been administered to more than 600 subjects in
multi-phase clinical trials to date. Results from these clinical
trials have demonstrated that NAV5001 has high affinity for DAT and
rapid kinetics which enable the generation of clean diagnostic
images quickly, beginning within approximately 20 minutes after
injection. In addition to its potential use as an aid in the
differential diagnosis of Parkinsonian syndromes and movement
disorders, NAV5001 may also be useful in the diagnosis of Dementia
with Lewy Bodies (DLB), which is the second most common cause of
progressive dementia after Alzheimer's disease.
About Parkinsonian Syndromes, Parkinson’s Disease and other
movement disordersParkinsonian syndromes and movement disorders
such as Essential Tremor represent a class of neurodegenerative
diseases with important diagnostic needs. Parkinsonian syndromes
(PS) are neurodegenerative disorders that affect a person’s ability
to control movement and other muscle functions. Parkinson's Disease
is the most common form of Parkinsonian Syndromes believed to be
caused by loss of dopamine producing neurons in the brain and with
first symptoms such as tremor, rigidity, or slow movement. Other
less common Parkinsonian Syndromes include multiple system atrophy
(MSA), Progressive Supranuclear Palsy (PSP), and drug-induced
Parkinsonism. The Parkinson’s Disease Foundation (PDF) estimates
that up to 10 million people worldwide are living with PD,
including 1 million people in the U.S. Approximately 60,000 new
cases of PD are diagnosed in the U.S. each year.1 The International
Essential Tremor Foundation estimates that as many as 10 million
people in the United States are afflicted by essential tremor.
PD is commonly misdiagnosed or completely missed in clinical
evaluations as symptoms are often attributed to the normal aging
process. Essential tremor and the other similar conditions are also
common sources of confusion in PD diagnosis. Collectively, there
are over 25 million people in the U.S. and Europe with some type of
movement disorder, comprising a large differential diagnosis
population.
About Compass Research, LLCCompass Research is a
multi-therapeutic, phase 1-4 clinical research company
headquartered in Orlando, FL, with additional research centers
located in Oviedo and Leesburg, FL. With proven experience since
1992, Compass has grown in size and industry presence to become one
of the premier research sites in the world. Compass serves over 200
sponsors, from small biotech companies to the world’s largest
pharmaceutical companies, and has completed over 1,300 trials. With
more than 300 years of combined clinical research experience, the
Compass team focuses on neurodegenerative research and is renowned
for its strength in enrolling specialty patient populations and
completing advanced diagnostic procedures. For more information,
please visit www.CompassResearch.com.
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
developing multiple precision diagnostic products and platforms
including NAV4694, NAV5001, Manocept™ and RIGScanTM , 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)
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behalf of the Company. Statements in this news release, which
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forward-looking statements that speak only as of the date hereof.
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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.
1 Parkinson’s Disease Foundation. Statistics on Parkinson’s:
http://www.pdf.org/en/parkinson_statistics. Accessed on August 21,
2013.
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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