'NAVB' - (Navidea Biopharmaceuticals Announces the Presentation of Lymphoseek(R) 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, Sep 20, 2012 (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
d emonstrating 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."
About Lymphoseek(R)
Lymphoseek(R) (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(R),
NAV4694, CFT and RIGScan(TM) - 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.
SOURCE: Navidea Biopharmaceuticals, Inc.
CONTACT:
Navidea Biopharmaceuticals, Inc.
Brent Larson, Sr. VP & CFO, 614-822-2330
Copyright Business Wire 2012
-0-
KEYWORD: United States
Spain
Europe
North America
Ohio
INDUSTRY KEYWORD: Health
Biotechnology
&nb sp; Clinical Trials
Medical Devices
Oncology
Pharmaceutical
Other Health
FDA
General Health
SUBJECT CODE: Conference
Product/Service
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