Navidea Biopharmaceuticals Announces the Presentation of Lymphoseek® Data at Joint International Onc

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Navidea Biopharmaceuticals Announces the Presentation of Lymphoseek®Data at Joint International Oncology Congress (JIOC)

Six presentations and sponsored lymphatic mapping symposium highlight results from Lymphoseek® clinical trials

DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its Lymphoseek® (technetium Tc 99m tilmanocept) Injection studies in patients with breast cancer, melanoma or head and neck cancer are being presented at the Joint International Oncology Congress (JIOC) from May 27-29, 2013 in San Francisco, CA. In addition to six oral and poster presentations focusing on important Lymphoseek technical and comparative performance characteristics, Navidea is sponsoring an educational symposium during the conference entitled, "Charting the Course: New Advances in Lymphatic Mapping" featuring presentations by five highly-respected key opinion leaders in the area of lymphatic mapping.


"We are honored by the opportunity to showcase our many peer-reviewed presentations at JIOC given its renowned international faculty of leading experts in the field of lymphatic mapping and oncology," said Dr. Thomas Tulip, President and Chief Business Officer of Navidea. "These activities are part of our strategy to build global awareness for Lymphoseek following the recent U.S. approval and launch as we gain commercial momentum domestically and anticipate approval of the Marketing Authorization Application by the European Medicines Agency later this year. We continue our efforts to broaden and expedite access to Lymphoseek in other parts of the world, and having advanced to letters of intent with potential partners in substantial international markets, we hope to announce the execution of new commercialization agreements in the near future."

"The presentations and posters at JIOC by Navidea and our collaborators provide notable insights into key attributes of the Lymphoseek product and franchise. The data presented demonstrate the comparative performance of Lymphoseek to non-receptor targeted colloidal materials used in lymphatic mapping in the U.S. and Europe, and the excellent localization of Lymphoseek in tumor-positive sentinel nodes in intraoral squamous cell carcinoma," said Dr. Mark Pykett, CEO of Navidea. "We believe these data enhance the understanding and scope of Lymphoseek utilization as we continue to drive the science and value of this important agent, and may afford new opportunities to capitalize on its unique mechanism of action."

Details of the symposium, oral and poster presentations are listed below.

Presentation & Poster Title:

  

Employing a receptor targeted SLN mapping agent significantly reduces
the probability of false SLN localization based on receptor binding correlation
with in vivo receptor localization in breast cancer patients.

 
Author:

Frederick O. Cope, PhD, Navidea Biopharmaceuticals et al.

 

Presentation & Poster Title:

Comparison of 99mTc-tilmanocept with European 99mTc-colloidial
intraoperative lymphatic mapping agents in sentinel lymph node biopsy in

breast cancer.

 

Author:

Alice Chung, MD, Cedars-Sinai Medical Center, Los Angeles, CA et al.

 

Presentation & Poster Title:

The CD206 receptor-targeted intraoperative lymphatic mapping agent
99mTc-tilmanocept has significantly higher localization in intraoral squamous
cell carcinoma-associated sentinel nodes that are tumor-positive due to the
recruitment of tumor proximal CD206-expressing dendritic cells in addition to
macrophages.

 

Author:

Larry S Schlesinger, MD, The Ohio State University, Columbus, OH et al.

 

Poster Title:

Evaluation of human mannose receptor (CD206) binding of 99mTc-
tilmanocept: a novel receptor-targeted lymphatic mapping agent for solid
tumors

 
Author:

Larry S Schlesinger, MD, The Ohio State University, Columbus, OH et al.

 

Poster Title:

Quantification of Sentinel Lymph Node (SLN) Uptake and Injection Site
Clearance (ISC) via dynamic SPECT/CT of receptor-driven Tc99m
Tilmanocept vs. Tc99m sulfur colloid: A Pilot study via dynamic SPECT/CT in
Intraoperative Lymphatic Mapping (ILM) for breast cancer

 
Author:

Nathan C. Hall, MD PhD, The Ohio State University, Columbus, OH et al.

 

Poster Title:

Does the 10%-"rule" of gamma counting for intraoperative sentinel node
biopsy selection provide adequate data-based guidance for node selection?

 
Author:

James W Sayre, DrPH, UCLA, Los Angeles, CA et al.

 

Symposium:

Charting the Course: New Advances in Lymphatic Mapping

 

Topics and Speakers:

Topic: Lymphoscintigraphy & Lymphatic Mapping: Current Limitations
Edwin Glass, MD, Medical Imaging Center of Southern Californa, Veterans
Administration Hospital, Greater Los Angeles (moderator)

 

Topic: Tilmanocept in Melanoma: Multicenter, Phase 2 & 3 Experience
Vernon Sondak, MD, Moffitt Cancer Center (moderator)

 

Topic: Molecular Targeting of Sentinel Lymph Nodes
David Vera, PhD, UCSD and UCSD InVivo Cancer and Molecular Imaging

 

Topic: Lymphatic Mapping in Breast Cancer: Tilmanocept Phase 3
Anne Wallace, MD, UC San Diego School of Medicine and Moores Cancer
Center

 

Topic: Head & Neck Cancer: Lymphatic Mapping with Tilmanocept
Stephen Y. Lai, MD, PhD, FACS, The University of Texas, MD Anderson
Cancer Center

 

About Lymphoseek®

Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek was approved by the U.S. Food and Drug Administration in March, 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. The Company anticipates continuing development of Lymphoseek into other solid tumor areas that may include head and neck cancers, prostate cancer, thyroid cancer, lung/bronchus cancers, colorectal cancer and others.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 232,000 new cases of breast cancer, 77,000 new cases of melanoma and 67,000 new cases of head and neck/oral cancer are expected to be diagnosed in the United States in 2013.

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 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.



Navidea Biopharmaceuticals
Brent Larson, 614-822-2330
Executive VP & CFO
or
Stern Investor Relations, Inc.
Investor Relations
Beth DelGiacco, 212-362-1200

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