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Navidea and Collaborator Molecular Neuroimaging Enroll First Subject in NAV5001 Clinical Trial

Study to investigate [ ¹²³ I] NAV5001 SPECT imaging as a tool to evaluate dopamine transporters in the brain as start of program in Dementia with Lewy Bodies

DUBLIN, Ohio–(BUSINESS WIRE)– Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that collaborators at Molecular Neuroimaging, LLC (MNI) in New Haven, CT have enrolled the first subject in a clinical study to investigate the performance of [¹²³I]NAV5001 in a SPECT imaging procedure in connection with Navidea’s program to evaluate NAV5001 in Dementia with Lewy Bodies (DLB).

“This collaborative investigator-initiated study is an important first step in recommencing a full clinical development program for NAV5001 since our in-licensing this candidate in late 2012,” said Dr. Mark Pykett, Navidea’s President and CEO. “Collaborations such as this are integral to Navidea’s strategy to efficiently and effectively advance the development of our promising radiopharmaceutical pipeline and representative of our focus of being a leader in the field of precision diagnostics.”

“The study is the first leg of our program to evaluate the utility of NAV5001 in DLB, the leading form of dementia after Alzheimer’s disease and an important potential indication for NAV5001 medically and commercially,” commented Cornelia Reininger, MD, PhD, Navidea’s Senior Vice President and Chief Medical Officer. “During 2013, we look forward to following this study with the initiation of a Company-sponsored Phase 2b study of NAV5001 in DLB as well as the anticipated start of the Company’s pivotal parallel Phase 3 registration studies of NAV5001 as an aid in the differential diagnosis of Parkinsonian syndromes.”

The goal of this single center, open-label, investigator-initiated study will be to assess the distribution, safety and tolerability of NAV5001 as an agent to evaluate the integrity of the dopamine transporters in the brain, using healthy volunteers. NAV5001 is an investigational radiopharmaceutical imaging agent being developed as an aid in the differential diagnosis of Parkinsonian syndromes, including Parkinson’s disease (PD) and other movement disorders, as well as Dementia with Lewy Bodies (DLB). Danna Jennings, MD, Clinical Research Director at MNI will lead the investigator-initiated clinical study.

About NAV5001

[¹²³I]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 …read more
Source: FULL ARTICLE at DailyFinance

By Business Wirevia The Motley Fool

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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 –

DUBLIN, Ohio–(BUSINESS WIRE)– 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 …read more
Source: FULL ARTICLE at DailyFinance

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Navidea and Collaborator Molecular Neuroimaging Enroll First Subject in NAV5001 Clinical Trial

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