- Ability of receptor-targeted Lymphoseek to
accurately target appropriate lymph nodes may lessen patient
morbidity from extensive oral cavity surgery -
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced results from a post-hoc
analysis of patient data from the Company’s Phase 3 clinical trial
(NEO3-06) of Lymphoseek in head and neck cancer. The ability of
Lymphoseek to localize in sentinel lymph nodes is based on its
ability to target specific CD206 mannose receptor sites in
macrophages, a type of immune cell which resides in high
concentration in lymph nodes. In the NEO3-06 Phase 3 study,
Lymphoseek localization to lymph nodes showed a strong correlation
with a full regional lymph node dissection and pathology analysis
with a low false negative rate, a priority in identifying sentinel
nodes. Lymphoseek was also observed to home preferentially to
pathology-positive nodes at a higher rate than pathology-negative
nodes. These results suggest that Lymphoseek not only effectively
targets sentinel lymph nodes, but further that its ability to
highlight tumor-positive lymph nodes may be augmented
mechanistically by the recruitment of macrophages to
cancer-harboring lymph nodes.
"The accurate detection of tumor-draining lymph nodes is
fundamental for effective lymphatic mapping, to minimize lymph
tissue removal, and to provide clinically useful information
regarding potential cancer metastasis," said Francisco J. Civantos,
M.D., FCS, University of Miami School of Medicine, Miami, Fla.
"Approximately 75% of patients with stage 1 and 2 oral cavity head
and neck cancer may be substantially over-treated if they are
subjected to elective neck dissection, which involves surgical
removal of a regional lymph node chain involving 30 to 45 lymph
nodes. Receptor-targeted radiopharmaceuticals such as Lymphoseek,
that are designed to facilitate accurate and reliable diagnostic
evaluation of specific sentinel lymph nodes, can help spare
patients morbidity that may result from elective neck dissection
procedures."
“As a purpose-built, receptor-targeted radiopharmaceutical,
Lymphoseek is designed to target and accumulate in macrophages
present in tumor-draining lymphatic tissue,” said Frederick Cope,
Ph.D., Senior Vice President and Chief Scientific Officer of
Navidea. “Tumor-positive lymph nodes recruit cells called
Tumor-Associated Macrophages, or TAM’s, which are rich in CD206
receptors. The ability of Lymphoseek to specifically target and
accumulate in macrophages demonstrated in this study led to
localization of the product in tumor-draining pathology-positive
lymph nodes that was 18 times higher than in all disease-negative
lymph nodes. In the clinic, this reliable uptake of Lymphoseek into
appropriate tissue allows for accurate removal and assessment of
lymph nodes at highest risk of harboring occult metastases.”
The analysis, based on data from the Phase 3 clinical trial for
Lymphoseek in head and neck cancer (NEO3-06), evaluated 83 patients
to determine whether Lymphoseek localization in pathology-positive
lymph nodes was higher than its localization in pathology-negative
nodes, and if those results were consistent with the overall
sentinel lymph node population. Sentinel lymph nodes and/or
non-sentinel lymph nodes (nodes removed in elective neck
dissection, or END) were removed from patients undergoing sentinel
lymph node biopsy for head and neck squamous cell carcinoma, and
all lymph nodes were assessed for the presence of tumor.
Intraoperative counts were obtained for all lymph nodes removed
including END nodes. Average in vivo gamma counts for all lymph
nodes removed indicated that the count ratio of pathology-positive
nodes to pathology negative nodes was approximately 18:1
(p<0.0001). For sentinel lymph nodes only, the ratio was
>2.5:1 (p<0.016). The results were presented in an oral
session by Frederick Cope of Navidea Biopharmaceuticals, at the
2014 Annual Meeting of the Society of Nuclear Medicine and
Molecular Imaging (SNMMI) in St. Louis, Mo.
About the Lymphoseek Phase 3 Clinical Trial (NEO3-06) in Head
and Neck Cancer (Oral Cavity)
Navidea’s Phase 3 clinical trial (NEO3-06) of Lymphoseek was a
prospective, open-label, multicenter, within-patient study of
Lymphoseek® (technetium Tc 99m tilmanocept) Injection. It was
designed to identify sentinel lymph nodes (SLNs) and determine the
false negative rate (FNR) associated with Lymphoseek-identified
SLNs relative to the pathological status of non-SLNs in head and
neck and intraoral squamous cell carcinoma, which is the current
“gold standard.” The findings indicate that Lymphoseek accurately
identified SLNs in the trial subjects for assessment, and that it
is likely to be predictive of overall node pathology status.
Moreover, multiple level nodal dissections of patients in the trial
with cancer-positive lymph nodes led to an average removal of 38
lymph nodes per patient, whereas Lymphoseek on average would have
led to the removal of approximately 4 lymph nodes, representing a
substantial reduction in potential morbidity for patients with head
and neck cancer undergoing sentinel lymph node biopsy.
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
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 BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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