Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today
announced that results from investigator studies using Lymphoseek®
(technetium Tc 99m tilmanocept) injection are being presented at
the 2016 Annual Meeting of the Society of Nuclear Medicine and
Molecular Imaging (SNMMI) to be held June 11-15, 2016 in San Diego,
CA. The oral and poster presentations highlight the comparative
performance of Lymphoseek against commonly-used non-receptor
targeted colloidal materials as well as other performance
characteristics in breast cancer and melanoma.
Results being presented at SNMMI 2016 include:
Presentation Title: Use of
lymphoscintigraphy with Tc-99m tilmanocept does not affect the
number of nodes removed during sentinel node biopsy in breast
cancer Author: Jonathan Unkart, Anne Wallace, Surgery, University
of California San Diego, San Diego, CA Date: June 15, 2016 Session
Breast, Clinical Applications
Presentation Title:
Performance of Tc-99m tilmanocept when used alone is as or more
effective in localizing sentinel nodes than sulfur colloid plus
blue dye Author: J. Unkart,1 D. W. King,2 L. A. Christman,2 A. M.
Wallace1; 1UCSD, San Diego, CA, 2Statking Consulting, Inc,
Fairfield, OH Date: June 15, 2016 Session Breast, Clinical
Applications
Presentation Title: Comparative analysis
of 99mTc-Tilmanocept (Lymphoseek) vs. 99mTc-Sulfur Colloid Sentinel
Node Lymphoscintigraphy and Biopsy Author: J. H. Pollard, B. Zaidi,
M. Graham; University of Iowa Hospital, Iowa City, IA Date: June
14, 2016 Session: Sarcoma/Melanoma
Poster Title: Rate
of sentinel lymph node visualization in fatty breasts: Tc-99m
Tilmanocept versus Tc-99m filtered sulfur colloid Author: Maryam
Shahrzad, Valeria Moncayo, John Malko, and Raghuveer Halkar; Emory
University School of Medicine, Atlanta, GA Date: June 13, 2016
Session Oncology, Clinical Science Track - MTA I: Breast Cancer
Posters
About Lymphoseek
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the
first and only FDA-approved receptor-targeted lymphatic mapping
agent. It is a novel, receptor-targeted, small-molecule
radiopharmaceutical used in the evaluation of lymphatic basins that
may have cancer involvement in patients. Lymphoseek is designed for
the precise identification of lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer.
Lymphoseek is approved by the U.S. Food and Drug Administration
(FDA) for use in solid tumor cancers where lymphatic mapping is a
component of surgical management and for guiding sentinel lymph
node biopsy in patients with clinically node negative breast
cancer, melanoma or squamous cell carcinoma of the oral cavity.
Lymphoseek has also received European approval in imaging and
intraoperative detection of sentinel lymph nodes in patients with
melanoma, breast cancer or localized squamous cell carcinoma of the
oral cavity.
Accurate diagnostic evaluation of cancer is critical, as results
guide therapy decisions and determine patient prognosis and risk of
recurrence. Overall in the U.S., solid tumor cancers may represent
up to 1.2 million cases per year. The sentinel node label in the
U.S. and Europe may address approximately 600,000 new cases of
breast cancer, 160,000 new cases of melanoma and 100,000 new cases
of head and neck/oral cancer diagnosed annually.
Lymphoseek Indication and Important Safety
Information
Lymphoseek is a radioactive diagnostic agent indicated with or
without scintigraphic imaging for:
• Lymphatic mapping using a handheld gamma
counter to locate lymph nodes draining a primary tumor site in
patients with solid tumors for which this procedure is a component
of intraoperative management.
• Guiding sentinel lymph node biopsy using a
handheld gamma counter in patients with clinically node negative
squamous cell carcinoma of the oral cavity, breast cancer or
melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity
reactions were reported, however Lymphoseek may pose a risk of such
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be
asked about previous hypersensitivity reactions to drugs, in
particular dextran and modified forms of dextran. Resuscitation
equipment and trained personnel should be available at the time of
Lymphoseek administration, and patients observed for signs or
symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer.
Adhere to dose recommendations and ensure safe handling to minimize
the risk for excessive radiation exposure to patients or health
care workers. In clinical trials, no patients experienced serious
adverse reactions and the most common adverse reactions were
injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND
AT:WWW.LYMPHOSEEK.COM
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision immunodiagnostic agents and
immunotherapeutics. Navidea is developing multiple
precision-targeted products and platforms including Manocept™ and
NAV4694 to help identify the sites and pathways of undetected
disease and enable better diagnostic accuracy, clinical
decision-making, targeted treatment and, ultimately, patient care.
Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s
first commercial product from the Manocept platform, was approved
by the FDA in March 2013 and in Europe in November 2014. The
development activities of the Manocept immunotherapeutic platform
will be conducted by Navidea in conjunction with its subsidiary,
Macrophage Therapeutics. Navidea’s strategy is to deliver superior
growth and shareholder return by bringing to market novel products
and advancing the Company’s pipeline through 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, our
ability to repay our debt, the outcome of the CRG litigation,
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.
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Investors & MediaNavidea Biopharmaceuticals,
Inc.Sharon Correia, 978-655-2686Senior Director, Corporate
Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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