- Data supporting sNDA demonstrate Lymphoseek
clinical utility in lymphatic mapping, independent of surgery
performed day of or day after injection -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced results from combined
analyses of Phase 3 clinical trials that evaluated Lymphoseek®
efficacy in lymphatic mapping for identifying pathology-positive
lymph nodes across multiple solid tumor types: melanoma, breast
cancer and head and neck squamous cell carcinoma. The results
indicated that Lymphoseek sensitivity for sentinel lymph node
mapping was consistent across the tumor type studies, regardless of
whether surgery was conducted on the same day as, or on the day
after injection of Lymphoseek. Additionally, for patients with head
and neck cancer, Lymphoseek demonstrated a low false negative rate
(FNR) of 2.6% (4.6% for same day injection before surgery and 0.0%
FNR in patients injected the day prior to surgery). Results from
the study comprise part of an sNDA filing for Lymphoseek which is
under review by the U.S. Food and Drug Administration.
“Flexibility and the ability to predictably image and schedule
lymphatic mapping procedures either the day before or on the same
day of surgery enable efficient and economical utilization of staff
and healthcare resources,” said James O’Donnell, M.D., Division
Chief, Nuclear Medicine, UH Case Medical Center, Cleveland, Ohio.
“The convenience of receptor-targeted imaging agents such as
Lymphoseek, which can provide diagnostic accuracy, rapid injection
site clearance and predictable lymph node uptake, facilitate
lymphatic mapping and informed diagnostic evaluation by clinicians
for patients who may have breast cancer, melanoma or head and neck
cancer.”
“These results clearly demonstrate the clinical adaptability and
utility of Lymphoseek in sentinel lymph node lymphatic mapping to
reliably identify tumor-draining lymph nodes that may be at high
risk of harboring cancer in patients with breast cancer, melanoma
or head and neck squamous cell carcinoma,” said Cornelia Reininger,
M.D., Ph.D., Senior Vice President and Chief Medical Officer of
Navidea. “Our sNDA for Lymphoseek use in sentinel node biopsy in
patients with head and neck cancer, based in part on this study, is
in Priority Review with the FDA with an approaching PDUFA date of
June 16, 2014. Results from this study are also included in a
second sNDA for Lymphoseek label expansion currently in review with
the FDA, which is designed to support more flexible utilization of
Lymphoseek in lymphatic mapping and lymphoscintigraphy imaging.
These applications reflect Navidea’s commitment to expanding usage
and indications for Lymphoseek and our belief that the product can
provide a flexible, reliable and cost-effective solution for
lymphatic mapping across a wide range of tumor types.”
The study evaluated Lymphoseek sensitivity in 384 evaluable
patients from three pivotal Phase 3 clinical studies: two Phase 3
studies in patients with breast cancer and melanoma (melanoma,
n=153; breast cancer, n=148) and one Phase 3 study in patients with
head and neck squamous cell carcinoma (n=83). Patients were
injected before surgery, imaged, and then surgery was conducted up
to 30 hours post-injection. Results based on sensitivity for
day-of-injection or day-after-injection were compared.
Meta-analysis results across tumor types (n=100 pathology-positive
patients) indicated per patient sensitivity for Lymphoseek in
identifying pathology-positive subjects. Sensitivity for Lymphoseek
was 99% in same day injection procedures, and 99% in surgery
procedures performed the day after injection. In addition, the FNR
for patients with head and neck squamous cell carcinoma was 4.6%
(95% CI: 0.1%-22.8%) for same day injection (n=40) and 0.000 (95%
CI: 0%-20.6%) for patients who had surgery on the day after
injection (n=42). The data were presented by Bonnie Abbruzzese,
Director, Clinical Research, MS, RD, CCRA, Navidea
Biopharmaceuticals, at the 2014 Annual Meeting of the Society of
Nuclear Medicine and Molecular Imaging (SNMMI) in St. Louis,
Mo.
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 (FDA) 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 other head
and neck cancers such as thyroid cancer, prostate cancer and
cancers of the female reproductive system (e.g., cervix,
endometrial and vulva cancer). Lymphoseek was granted Fast Track
and Priority Review designation for its sNDA for sentinel lymph
node detection in patients with head and neck cancer and is
currently in review with the FDA.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. According to publicly available information,
approximately 235,000 new cases of breast cancer, 76,000 new cases
of melanoma and 69,500 new cases of head and neck/oral cancer are
expected to be diagnosed in the United States in 2014, and
approximately 367,000 new cases of breast cancer, 83,000 new cases
of melanoma and 137,000 new cases of head and neck/oral cancer
diagnosed in Europe annually.
U.S. Indication and Important Safety Information About
Lymphoseek
Indication
Lymphoseek (technetium Tc 99m tilmanocept) Injection is a
lymphatic mapping agent indicated for use with a hand-held gamma
counter to assist in the localization of lymph nodes draining a
primary tumor site in patients with 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.
The most common adverse reactions are injection site irritation
and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND
AT:WWW.LYMPHOSEEK.COM
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 developing multiple precision diagnostic
products and platforms, including NAV4694, NAV5001, Manocept™ and
NAV1800 (RIGScan™), to help identify the sites and pathways of
undetected disease and enable better diagnostic accuracy, clinical
decision-making 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. 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
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anticipated clinical and regulatory pathways, and markets for the
Company’s products are forward-looking statements within the
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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 BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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