- Results Presented at Society of Surgical
Oncology Cancer Symposium Indicate Low Regional Recurrence and High
Disease-Specific Survival Rates -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced results of a three-year,
voluntary follow-up study of Lymphoseek® (technetium Tc 99m
tilmanocept) Injection conducted in patients who participated in a
Phase 3 clinical trial (NEO3-05) of the product. The primary
objective of the follow-up study was to determine the regional
(i.e., draining lymph node basin) recurrence-free rate (RRFR) after
sentinel lymph node biopsy with Lymphoseek. Results of the
follow-up study indicated that in patients who were confirmed to be
node-negative (N0) after sentinel lymph node biopsy (n=88; 49
breast cancer, 39 melanoma) the RRFR was 98.8% (100% in breast
cancer; 97.4% in melanoma) and the disease-specific survival rate
(DSSR) was 98.6% (97.8% in breast cancer; 100% in melanoma) at
three years. The results, presented by Stephen P. Povoski, MD, of
The Ohio State University Wexner Medical Center, will also be
highlighted in a Grand Rounds presentation as one of several
Lymphoseek presentations at SSO 2014, the 67th Society of Surgical
Oncology Annual Cancer Symposium, in Phoenix, Arizona. Lymphoseek
is a novel, receptor-targeted, small-molecule radiopharmaceutical
approved by the U.S. Food and Drug Administration for use in
lymphatic mapping to assist in the localization of lymph nodes
draining primary tumor in patients with breast cancer or
melanoma
Findings from the Lymphoseek follow-up study compare favorably
with outcomes from previously reported data from other studies. A
study reported in the New England Journal of Medicine which
evaluated the use of sentinel node biopsy or nodal observation
node-negative (N0) melanoma patients1 showed a DSSR at three years
of 90.1%. In another study published in Lancet Oncology2,
node-negative (N0) breast cancer patients had an estimated
disease-free survival rate at five years of 88.6%.
“Sentinel lymph node biopsy is well-established as an
appropriate alternative to full lymph node dissection in
node-negative, early-stage breast cancer and melanoma patients, and
it can spare patients of the resultant morbidities associated with
full lymph node dissection,” said Dr. Povoski. ”This three-year
follow-up analysis was performed to assess outcomes associated with
Lymphoseek-guided sentinel lymph node removal. Our findings support
the contention that Lymphoseek, which has previously been shown to
accurately identify tumor-draining sentinel lymph nodes in both
early-stage breast cancer and melanoma patients, results in a very
high detection rate, with patient outcome at three years of follow
up demonstrating a very low recurrence rate and a high survival
rate.”
“Surgeons are acutely aware of the importance of accurate
diagnostic evaluation in assessing their patients’ conditions, and
we are pleased that these results from the Lymphoseek NEO3-05
follow-up study are being made available to surgeons attending the
prestigious Society of Surgical Oncology Cancer Symposium,” said
Cornelia Reininger, MD, PhD, Senior Vice President and Chief
Medical Officer of Navidea. “We believe these results underscore
the important role of Lymphoseek in providing physicians with
critical information, since for those breast cancer and melanoma
patients overall whose nodes were determined to be free of cancer
at the beginning of the study, 98.8% did not have any cancer in
their lymph nodes after three years.”
In a second presentation at the meeting, Dr. Jennifer Baker of
the University of California, San Diego presented results from
combined efficacy analyses of three Phase 3 Lymphoseek clinical
trials in breast cancer, melanoma and head and neck cancer
patients. The data showed that Lymphoseek demonstrated high
sensitivity, as well as high negative predictive value and accuracy
in identifying tumor-draining lymph nodes, and that it is likely to
be predictive of pathological staging.
Both poster presentations can be viewed in the Publications
section of Navidea website located
at:http://www.navidea.com/development-programs/publications/bibliography.html
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 head and
neck cancers, prostate cancer, thyroid cancer, lung/bronchus
cancers, colorectal cancer and others. 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
1Morton, DL, Thompson JF, Cochran AJ, et al. Sentinel-Node
Biopsy or Nodal Observation in Melanoma. N Engl J Med
2006;355:1307-1317.
2Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node
resection compared with conventional axillary-lymph-node dissection
in clinical node-negative patients with breast cancer: overall
survival findings from the NSABP B-32 randomised phase 3 trial.
Lancet Oncol 2010;11(10):927-933.
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 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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