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Data Comparing Navidea's AZD4694 to Gold-Standard 11C-PIB in Beta Amyloid Imaging Presented at Society of Nuclear Medicine Meeting

DUBLIN, Ohio--(BUSINESS WIRE)--Jun 11, 2012 - Navidea Biopharmaceuticals, Inc. (NYSE Mkt: NAVB), a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that clinical data comparing its amyloid imaging candidate, AZD4694, to the benchmark amyloid imaging agent, 11C-PIB, was presented at the Society of Nuclear Medicine Annual Meeting in Miami, Florida.

Professor Christopher Rowe, MD, FRACP, Director of the Department of Nuclear Medicine and Centre for PET at Austin Health, Melbourne, Australia, presented a talk entitled “Comparison of 11C-PiB and 18F-AZD4694 for Aβ imaging in ageing and dementia” during the meeting session on “Quantifying Brain Amyloid Signal - Methods & Challenges.” The presentation highlighted results of a study examining imaging characteristics such as binding kinetics, standard uptake values ratios (SUVR), and non-specific white-matter retention for these agents obtained in the same subjects. Forty-five participants (25 healthy elderly controls, 10 with Mild Cognitive Impairment, 7 with Alzheimer's Disease and 3 with fronto-temporal dementia) underwent PET imaging with both 11C-PIB and AZD4694. The quantitative measures of 18F-AZD4694 binding to cortical amyloid plaques such as SUVR showed almost identical results to 11C-PIB and very tight performance correlation (r=0.98, p<0.0001; slope 0.95). Visually, images obtained in the same patient with the same scan times, the same data processing and the same display scales, were identical. 18F-AZD4694 had comparable binding kinetics and dynamic range of SUVR to the benchmark 11C-PiB as well as similar high values of cortex to white matter ratios.

“By overcoming the practicality issues of using 11C-PIB, 18F-AZD4694's favorable imaging characteristics provide the potential to act as a formidable radiotracer facilitating research, diagnosis and therapeutic development for Alzheimer's disease,” said Dr. Rowe. “We look forward to publishing the study results for the assessment of this promising agent to aid the diagnosis of patients with Alzheimer's disease in the coming months.”

“These results continue to confirm AZD4694's outstanding performance characteristics. With this study we can demonstrate a direct comparison to the long-standing agent of choice, PIB,” commented Thom Tulip, Navidea's Executive Vice President and Chief Business Officer. “We believe that this agent's strong sensitivity, specificity and better contrast may enable earlier Alzheimer's disease identification, better monitoring of disease progression and response to treatment over time, and easier scan interpretation in clinical practice.”

About AZD4694

AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as AD. It binds to Beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD diagnosis and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD.

About Navidea Biopharmaceuticals, Inc.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents. Navidea is actively developing three radiopharmaceutical agent platforms – Lymphoseek®, AZD4694 and RIGScanTM – 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, Inc.
Brent Larson, Sr. VP & CFO, 614-822-2330

 

Posted: June 2012

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