- Data from Study Presented at San Antonio
Breast Cancer Conference -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) today
announced that results from an investigator-initiated retrospective
analysis demonstrated Lymphoseek® (technetium Tc 99m tilmanocept)
injection was successful in lymph node identification rate,
node-positivity rate, and number of total nodes evaluated in
sentinel lymph node biopsy (SLNB) procedures in clinically
node-negative breast cancer patients undergoing neoadjuvant
chemotherapy (NAT) compared to patients undergoing initial surgical
treatment. These findings suggest that Lymphoseek offers breast
surgeons the confidence to specifically identify and remove
sentinel lymph nodes in this patient population. Results of the
study conducted at the University of California, San Diego, School
of Medicine, led by Anne Wallace M.D., professor of surgery, and
Jonathan Unkart, M.D., Department of Surgery, UC San Diego Health,
were presented today at the San Antonio Breast Cancer Conference in
San Antonio, Texas.
“Prior thinking suggests that neoadjuvant chemotherapy may
induce fibrosis and inflammation that alters lymphatic drainage of
axillary lymph nodes in breast cancer and may obscure lymphatic
mapping procedures,” said Dr. Wallace, who is also director of the
Comprehensive Breast Health Center at UC San Diego Moores Cancer
Center. “This analysis provides compelling evidence that Lymphoseek
was successfully used for SLNB in the breast cancer neoadjuvant
chemotherapy population and could potentially reduce the necessity
for unnecessary and morbid axillary dissections, and improve the
quality of life for patients.
“One of the most frequently asked questions we encounter from
physicians is on the effectiveness of Lymphoseek in NAT patients,”
commented Michael Tomblyn, M.D., Navidea’s Chief Medical Officer.
“These findings show Lymphoseek’s usefulness in the complicated NAT
population and that the outcomes are not different from the
standard breast cancer population.”
The aim of the study was to compare identification rate,
node-positivity rate and total number of nodes evaluated during
SLNB with Lymphoseek and vital blue dye (VBD) in clinically
node-negative patients receiving neoadjuvant endocrine or
chemotherapy versus initial surgical treatment. A retrospective
review of patients undergoing SLNB with Lymphoseek plus VBD from
May 2013-2015 at UCSD was conducted. Of the 417 total sentinel
lymph node (SLN) cases identified, 72 (17.2%) cases were in
patients who had received NAT (61- chemo, 11- endocrine). The SLN
identification rate was 100% in both groups (p=1.0). Overall, there
were 68 (16.3%) cases of SLN-positivity, 14 (19.4%) in the NAT
group versus 54 (15.7%) in the non-NAT group (p= 0.54). The median
number of identified nodes was 3 in both groups. In the a
zero-truncated negative binomial count model, age, surgeon and
evaluating pathologist were significant predictors of the total
number of SLNs evaluated. The use of NAT did not significantly
affect the number SLNs evaluated.
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), with or without scintigraphic imaging, 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 it
guides therapy decisions and determines 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 235,000 new cases
of breast cancer, 76,000 new cases of melanoma and 45,000 new cases
of head and neck/oral cancer in the U.S., and approximately 367,000
new cases of breast cancer, 83,000 new cases of melanoma and 55,000
new cases of head and neck/oral cancer diagnosed in Europe
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 immuno-diagnostic agents and
immuno-therapeutics. 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. 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, 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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version on businesswire.com: http://www.businesswire.com/news/home/20151210006238/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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