Navidea Biopharmaceuticals Announces the Presentation of Lymphoseek® Phase 3 Meta-Analysis Data at the 32nd Congress of the European Society of Surgical Oncology
– Dr. Frederick Cope presents meta-analysis data on Lymphoseek and radio-labeled colloidal agents during the Breast Cancer III podium session –
DUBLIN, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that data from its completed Phase 3 Lymphoseek studies in breast cancer and melanoma are being presented at the 32nd Congress of the European Society of Surgical Oncology (ESSO) in Valencia, Spain, from September 19-21, 2012. During the Breast Cancer III - Technical Aspect session, Frederick Cope, Ph.D., Navidea’s Senior Vice President of Pharmaceutical Research and Drug Development, will make an oral presentation of a meta-analysis comparison of data from Lymphoseek Phase 3 breast cancer studies and a meta-analysis of published literature on three colloidal agents evaluating two key clinical performance characteristics in intraoperative lymphatic mapping. In addition, Dr. Cope will present a poster of the results from combined Phase 3 clinical trials in breast cancer and melanoma demonstrating a positive correlation between preoperative imaging (lymphoscintigraphy) using Lymphoseek and the intraoperative/surgical findings of tumor-draining lymph nodes.
“We are extremely pleased with the opportunity to present these results from our Lymphoseek Phase 3 trials to this important European medical audience,” said Mark Pykett, Ph.D., President and CEO of Navidea. “We remain on plan to submit our Marketing Authorization Application (MAA) in the European Union by the end this year and believe that Lymphoseek can address a significant medical need for those with solid tumor cancers in Europe.”
Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage 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, in patients with breast cancer or melanoma.
Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. Accurate staging of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to the American Cancer Society, approximately 229,000 new cases of breast cancer and 76,000 new cases of melanoma are expected to be diagnosed in the United States in 2012.
About Lymphatic Mapping
Lymphatic mapping is a procedure designed to guide lymph node dissection and biopsy procedures. It consists of Intraoperative Lymphatic Mapping (ILM) often accompanied by lymphoscintigraphy. Lymphoscintigraphy is an imaging procedure routinely performed pre-operatively to provide guidance on the location of lymph nodes to be biopsied. ILM is a surgical procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. These nodes, commonly referred to as “Sentinel Lymph Nodes,” are removed and analyzed for the presence of malignant cells. Lymphatic Mapping provides an accurate staging procedure that can help ensure optimal surgical and therapeutic choices, including the avoidance of the morbidity of a complete lymph node dissection for patients in whom the Sentinel Lymph Nodes were found to be free of cancer.
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, CFT 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, Inc.
Brent Larson, Sr. VP & CFO, 614-822-2330
Source: Navidea Biopharmaceuticals, Inc.
Released September 20, 2012