Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today provided updates on several programs
and events relating to Lymphoseek® (technetium Tc 99m tilmanocept)
Injection, including a head-to-head clinical study underway at the
University of California, San Diego (UCSD). The UCSD study is
comparing the level of discomfort experienced by breast cancer
patients after injection of Lymphoseek or radiolabeled sulfur
colloid in lymphatic mapping procedures. Navidea also highlighted
updates on the European filing for Lymphoseek with the Marketing
Authorization Application (MAA) and multiple upcoming medical and
scientific presentations. 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 a primary tumor in patients
with breast cancer or melanoma.
Head-to-Head Clinical Study Comparing Injection Pain
Associated with Radiolabeled Sulfur Colloid vs. Lymphoseek
The investigator-initiated study underway at UCSD marks the
first prospective, randomized, double-blinded controlled clinical
study to address the issue of injection site pain between two
radiopharmaceuticals that are commonly used in lymphatic mapping
procedures. It is designed to determine if patients receiving
Lymphoseek experience the same or less pain following injection
compared to radiolabeled sulfur colloid, and to measure the amount
of discomfort that patients report during and after injection. The
study is also exploring comparative performance characteristics
such as amount of time to sentinel lymph node visualization on
lymphoscintigraphy imaging prior to surgery, sentinel lymph node
localization success and the number of tumor draining lymph nodes
removed.
“Surgeons who perform sentinel lymph node biopsy procedures in
breast cancer and melanoma patients focus not only on clinical
outcomes, but on optimizing the patient’s overall experience during
a vulnerable time,” said Anne Wallace, M.D., Professor of Surgery,
UC San Diego School of Medicine; Director of the Comprehensive
Breast Health Center; UC San Diego Moores Cancer Center, and
Principal Investigator on the study. “It is well accepted that
sentinel node injection can be painful. We designed this study to
try to understand if Lymphoseek injection is less painful and could
improve the patient experience.”
Dr. Wallace continued, “This study is also exploring additional
technical outcomes with these imaging agents that may result in
better standardization of the lymphatic mapping technique for
surgeons. For example, lymphoscintigraphy imaging is frequently
performed prior to surgery to facilitate surgical planning, but
visualization of tumor-draining lymph nodes using conventional
agents can vary, and is known to decrease with increasing patient
age and weight. Further evaluation in this prospective study with
controlled imaging time points can help us verify previously
collected preliminary data, to enable more informed surgical
protocols.”
Lymphoseek Marketing Authorization Application (MAA)
Update
Navidea has also made progress with the Lymphoseek
Marketing Authorization Application (MAA) in Europe.
Following Navidea's presentation of Oral Explanations to the
European Medicines Agency’s (“EMA”) Committee for Medicinal
Products for Human Use (“CHMP”) on March 19, 2014, the Company
anticipates that CHMP will convene the Scientific Advisory Group on
Oncology (SAG-O) to discuss additional elements of the Lymphoseek
clinical study in patients with head and neck cancer. The SAG-O
meeting will provide an opportunity for Navidea and independent
experts in head and neck cancer surgery to review clinical
data in the MAA filing and discuss broad aspects of care for
patients with head and neck cancer in Europe. During this process,
the MAA remains active and the review clock will continue to
be stopped while Navidea works with the CHMP to continue expanded
discussions.
Scientific Advisory Groups (SAGs) are created by the CHMP to
provide independent advice on scientific/technical matters relating
to products under evaluation by the CHMP, or on any other
scientific issue relevant to the work of the CHMP that relates to
this area. The SAG, appointed by CHMP, will include clinicians and
experts in the field of head and neck surgery and oncology. The
CHMP, while taking into account the position expressed by the SAG,
remains responsible for its final opinion.
Lymphoseek Presentations at Upcoming Scientific
Conferences
Results from Lymphoseek studies will be presented at the
following conferences in April and May.
6th European Congress on Head and Neck
Oncology
April 24-26, 2014, Liverpool, UK
Oral Presentation: Receptor-targeted 99mTc-tilmanocept For
Sentinel Lymph Node Biopsy (SLNB) In HNSCC: Predictive Utility Vs.
Elective Neck Dissection
Author: Stephen Y. Lai, MD PhD, FACS, The University of Texas MD
Anderson Cancer Center, Houston, TX
American Society of Breast Surgeons
April 30 – May 4, 2014, Las Vegas, Nevada
Poster Title: Sensitivity and specificity of 99mTc-tilmanocept,
a CD206-targeted molecular sentinel node mapping agent in breast
cancer
Author: Anne Wallace, MD, Professor of Surgery, UC San Diego
School of Medicine; Director of the Comprehensive Breast Health
Center; UC San Diego Moores Cancer Center
The Company further announced that 12 Lymphoseek and Manocept™
platform abstracts from Navidea and collaborators will be presented
at the 2014 Annual Meeting of the Society of Nuclear Medicine and
Molecular Imaging (SNMMI) in June 2014. Additional information will
follow in a subsequent release.
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
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, Executive VP & CFO,
614-822-2330orSharon Correia, Associate Director, Corporate
Communications, 978-655-2686
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