- Study to Evaluate Lymphoseek in a
Pediatric Population in Melanoma, Rhabdomyosarcoma, or Other Solid
Tumors -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), today
announced that the first pediatric patient was enrolled in a
clinical study comparing Lymphoseek® (technetium Tc 99m
tilmanocept) injection and vital blue dye (VBD) in a pediatric
population of patients with melanoma, rhabdomyosarcoma, or other
solid tumors. The study is designed to investigate how Lymphoseek
compares with VBD in identifying lymph nodes as well as evaluate
safety and tolerability in the pediatric population. Lymphoseek is
designed for the precise identification of lymph nodes that drain
from a primary tumor, which have the highest probability of
harboring cancer and is approved for adult use only. Enrollment is
currently planned at approximately six sites throughout the U.S.
The first patient has been enrolled by the Nationwide Children's
Hospital in Columbus, OH.
“We are pleased to participate in this important clinical study
of Lymphoseek in the pediatric patient population where no lymph
node mapping agents have yet been approved,” said Jennifer Aldrink,
M.D., Assistant Professor of Clinical Surgery, The Ohio State
University College of Medicine and Director of Surgical Oncology,
Division of Pediatric Surgery at Nationwide Children's Hospital in
Columbus, OH. “Intraoperative Lymphatic Mapping (ILM) and Sentinel
Lymph Node Biopsy (SLNB) are standards of care in adult and
pediatric patients in several forms of cancer, and Lymphoseek is a
new agent being used in many adult centers as an alternative to
sulfur colloid formulation. Lymphoseek may have the potential to
aid physicians in evaluating lymph nodes in children that are
necessary for accurate disease staging and optimal post-surgical
treatment.”
“This study will provide further data on the overall clinical
value of Lymphoseek, which has already shown to be a highly
effective immunodiagnostic tool in adult patients. Medical
literature supports the importance of lymph node evaluations in
pediatric patients with rhabdomyosarcoma and melanomas noting that
lymph node metastases are highly associated with poorer survival,”
said Michael Tomblyn, M.D., Chief Medical Officer of Navidea.
“Until now, there have been few studies of ILM and SLNB in
children. We look forward to the opportunity to evaluate
Lymphoseek’s use in pediatric populations.”
This study (NAV3-18) is a prospective, open-label, multicenter
study comparing Lymphoseek® and VBD as lymphoid tissue targeting
agents in pediatric patients with melanoma, rhabdomyosarcoma, or
other solid tumors who are undergoing lymph node mapping. Primary
goals of this study are to evaluate safety and tolerability of
Lymphoseek in this subject population and determine the concordance
of in vivo detection rates of Lymphoseek and of VBD in tissue
excised and histologically confirmed as lymph nodes. In addition,
the study will measure other efficacy signals including assessment
of the identified lymph node(s) to confirm: the presence/absence of
tumor metastases; agent localization per tumor type; degree of
localization (nodes per subject both intraoperatively and with
preoperative SPECT/CT); reverse concordance parameters; change of
subject stage based on histopathology and descriptive assessment on
change in treatment plan; number of lymph nodes detected with
Lymphoseek intraoperatively compared with preoperative SPECT/CT
imaging.
Information on the protocol and enrolling sites for this study
(NAV3-18) can be found at:
https://www.clinicaltrials.gov/ct2/show/NCT02509598?term=lymphoseek&rank=7
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 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160106005427/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate CommunicationsorDavid Shull or Chris Hippolyte,
858-717-2310david.schull@russopartnersllc.comChris.hippolyte@russopartnersllc.com
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