Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) today reported
that a Lymphoseek® (technetium Tc 99m tilmanocept) injection
presentation at the International Conference on Innovative
Approaches in Head and Neck Oncology contributes to a growing body
of data reinforcing the clinical value of Lymphoseek, specifically
for guiding sentinel lymph node biopsy in head and neck cancer
patients with squamous cell carcinoma of the oral cavity. The data,
presented by Remco de Bree, M.D., Ph.D. head and neck surgeon from
the VU University Medical Center, The Netherlands, included the
following:
- Lymphoseek is uniquely suited to
identify the sentinel lymph node where the injection site is in
very close proximity
- Previously reported clinical trial
data, which were used to obtain European approval in 2014 and which
demonstrated a 2.56% false negative rate for sentinel lymph node
detection compared to the gold standard of post-operative
histopathology
- There was no observable difference in
Lymphoseek performance when used either the day prior to or the day
of surgery
- Lymphoseek displayed a favorable safety
profile and delivered rapid and consistent injection site clearance
and localization to sentinel nodes.
“Not only was the detection rate of sentinel nodes by Lymphoseek
high, but it has other advantages,” said Professor de Bree. “Where
other tracers have problems in identifying and harvesting of
sentinel nodes when there is a close spatial relation between
injection site and sentinel node, which is pronounced in floor of
mouth tumors, tilmanocept facilitated accurate prediction of the
spread of the cancer in all oral cavity sites. With the recent
approval of Lymphoseek, surgeons are no longer limited to en-bloc
surgery of all the soft tissue in a lymph node region.”
“These data provide further support to the clinical value of
Lymphoseek to the surgical oncologist, reinforcing the rationale to
incorporate Lymphoseek in sentinel lymph node biopsy procedures,”
said Michael Tomblyn, M.D., Executive Medical Director for Navidea.
“The product offers surgeons in both the U.S. and Europe an
alternative that can reduce surgical requirements and may reduce
patient morbidity, in particular where the injection site is close
to the at-risk sentinel node, as is the case with cancers of the
oral cavity as well as breast cancer and malignant melanoma.”
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 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.
EU Lymphoseek® Indication and Important Safety
Information
Radiolabelled Lymphoseek is indicated for imaging and
intraoperative detection of sentinel lymph nodes draining a primary
tumour in adult patients with breast cancer, melanoma, or localised
squamous cell carcinoma of the oral cavity.
External imaging and intraoperative evaluation may be performed
using a gamma detection device.
Important Safety Information about Lymphoseek for EU &
U.S. patients
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%).
Prescribing information and more information about Lymphoseek
for EU patients will be available at:
http://ec.europa.eu/health/documents/community-register/index_en.htm.
For full prescribing information and more information about
Lymphoseek for U.S. patients, please visit: 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, therapeutics and
radiopharmaceutical agents. Navidea is developing multiple
precision-targeted products and platforms including Manocept™,
NAV4694, and NAV5001, 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 by the EMA in November 2014. Navidea’s
strategy is to deliver superior growth and shareholder return by
bringing to market novel radiopharmaceutical agents and
therapeutics, 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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