Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today
announced that the first patient has been enrolled in a clinical
study evaluating Lymphoseek® (technetium Tc 99m tilmanocept)
injection in women with known cervical cancer. The study, funded by
a Fast-track grant from the National Institutes of Health (NIH),
National Cancer Institute (NCI; 1R44CA180390-01) will assess the
use of Lymphoseek in sentinel lymph node biopsy (SLNB) during
cervical cancer surgery in support of the existing Lymphoseek label
in lymphatic mapping. Lymphoseek is designed for the precise
identification of lymph nodes that drain from a primary tumor,
which have the highest probability of harboring cancer. Enrollment
is currently planned in up to six sites throughout the U.S. The
first patient has been enrolled by the principal investigator,
Michael M. Frumovitz, M.D., M.P.H., Associate Professor, Department
of Gynecologic Oncology and Reproductive Medicine, at The
University of Texas MD Anderson Cancer Center.
“This important study could potentially advance the use of SLNB
procedures in cervical cancer. Clinical experience and published
results using Lymphoseek in other cancer types demonstrate that
imaging using Lymphoseek may enable detection of suspicious nodes
not previously possible,” said Frederick Cope, Ph.D., M.S.,
F.A.C.N., C.N.S., Senior Vice President and Chief Scientific
Officer of Navidea. “Improving current practice in lymph node
mapping and sentinel node detection in cervical cancer surgery may
lead to less extensive, more focused surgical procedures. More
reliable bilateral SLN identification may decrease the cost and
morbidity of complete lymph node dissection in women with early
stage cervical cancer.”
“There is currently a growing focus on sentinel lymph node
biopsy (SLNB) procedures in gynecologic cancers. Lymphoseek has
been safely and efficaciously used in SLNB and mapping procedures
in over 50,000 patients to date,” said Rick Gonzalez, President and
Chief Executive Officer of Navidea. “With Lymphoseek’s
immunodiagnostic properties of selective receptor targeting and
improved patient experience, we believe that this study and others
like it may accelerate the adoption of lymphatic mapping and SLNB
using Lymphoseek in cervical cancer and other solid tumor areas
with the intent of improving patient outcomes and reducing
post-surgical morbidities in patients undergoing these
procedures.”
This multi-center, prospective, open-label study is designed to
evaluate Lymphoseek® in patients with known cancer of the cervix.
The trial intends to enroll up to 40 women with International
Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1 staging.
Subjects will receive a single dose of Tc99m tilmanocept
administered peritumorally approximately 1-2 hours before surgery.
The results will report per-patient false negative rates and
compare the pathology status of Lymphoseek-identified sentinel
lymph nodes relative to the pathology status of non-sentinel lymph
nodes in nodal staging of patients. Additionally, the study will
report sensitivity, negative predictive value, and accuracy.
Concordance and reverse concordance of identified nodes will be
reported for the cases that use both Lymphoseek and a dye.
Information on the protocol for this study (NAV3-19) can be found
at:
https://www.clinicaltrials.gov/ct2/show/NCT02509585?term=lymphoseek&rank=5.
About Cervical Cancer
Cervical cancer is usually a slow-growing cancer that affects
~12,000 new patients each year in the U.S. Worldwide, the World
Health Organization notes that cervical cancer is both the fourth
most common cause of cancer and the fourth most common cause of
death from cancer in women. Globally in 2012, it was estimated that
there were 528,000 new cases of cervical cancer, and 266,000
deaths.
About Sentinel Lymph Node Biopsy1
A sentinel lymph node is defined as the first lymph node to
which cancer cells are most likely to spread from a primary tumor.
Sometimes, there can be more than one sentinel lymph node. A
sentinel lymph node biopsy (SLNB) is a procedure in which the
sentinel lymph node is identified using an imaging agent such as
Lymphoseek, removed, and examined to determine whether cancer cells
are present. A negative SLNB result suggests that cancer has not
developed the ability to spread to nearby lymph nodes or other
organs. A positive SLNB result indicates that cancer is present in
the sentinel lymph node and may be present in other nearby lymph
nodes or organs. This information helps a doctor determine the
stage of the cancer and develop an appropriate treatment plan. SLNB
may also help some patients avoid more extensive lymph node surgery
and post-surgical complications such as lymphedema, or tissue
swelling. SLNB is most commonly used to help stage breast cancer,
melanoma and head and neck cancers. SLNB is also being
evaluated along with lymphatic mapping in other cancer types,
including cervical, endometrial, anal, colorectal, gastric,
esophageal, thyroid, and non-small cell lung cancer.
Source: 1National Cancer Institute.
http://www.cancer.gov/about-cancer/diagnosis-staging/staging/sentinel-node-biopsy-fact-sheet#q3;
accessed February 10, 2016.
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 results
guide therapy decisions and determine 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 600,000 new cases of
breast cancer, 160,000 new cases of melanoma and 100,000 new cases
of head and neck/oral cancer diagnosed 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 immunodiagnostic agents and
immunotherapeutics. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160211005394/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate CommunicationsorDavid Schull / Chris Hippolyte,
858-717-2310david.schull@russopartnersllc.comChris.hippolyte@russopartnersllc.com
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From Apr 2024 to May 2024
Navidea Biopharmaceuticals (AMEX:NAVB)
Historical Stock Chart
From May 2023 to May 2024