- Study Presented at the 2015 Society of
Nuclear Medicine and Molecular Imaging Conference -
Navidea Biopharmaceuticals (NYSE MKT: NAVB), announced that
results from an investigator-initiated, comparative study of
Lymphoseek® (technetium Tc 99m tilmanocept) injection versus
filtered Tc-99m Sulfur Colloid (fTcSC) measuring injection site
pain in patients with breast cancer undergoing lymphoscintigraphy
were presented at the 2015 Society of Nuclear Medicine and
Molecular Imaging (SNMMI) conference. The results of the
randomized, double-blinded trial, led by Anne Wallace, M.D.,
professor of surgery at University of California, San Diego School
of Medicine, highlighted that fTcSC caused statistically
significant greater levels of pain after injection compared to
Lymphoseek.
In preparation for Sentinel Lymph Node Biopsy in breast cancer
and other cancers, lymphatic pathways are mapped using a procedure
called lymphoscintigraphy. “Patients often fear this procedure
given the evidence of injection pain from some radiotracers,” said
Dr. Wallace, who is also director of the Comprehensive Breast
Health Center at UC San Diego Moores Cancer Center. “This study of
tilmanocept demonstrated, with patient-reported data, a
significantly reduced level of post-injection associated pain
compared with use of an fTcSC tracer. Along with its other
desirable performance characteristics, surgeons now have a reliable
tool that can potentially play an important role in improved
patient comfort and management.”
“This investigator-initiated study is of particular importance
as it continues to reinforce the clinical value of Lymphoseek,”
said Michael Tomblyn, M.D., Navidea’s Executive Medical Director.
“While previous studies have reported on Lymphoseek efficacy and
ongoing safety, these results further illustrate both the clinical
utility and clear benefits to both surgical oncologists and
patients.”
The poster presentation entitled, ”A Randomized Double-Blinded
Comparison of Injection Site Pain of Tc-99m Tilmanocept versus
Filtered Tc-99m Sulfur Colloid in Patients Undergoing Lymph Node
Mapping for Breast Cancer” showed results of the randomized,
double-blind clinical trial comparing post-injection site pain
using fTcSC versus Lymphoseek in 52 [(27) fTcSC and (25)
Lymphoseek] breast cancer patients undergoing lymphoscintigraphy.
Pain was evaluated with a visual analogue scale and short form
McGill Pain Questionnaire at 1, 2, 3, 4, 5, 15 and 30 minutes
post-injection. Analysis of the data indicates baseline pain scores
were similar between groups. At one minute post-injection, patients
receiving fTcSC experienced a mean change in pain of 16.8mm
(standard deviation (SD) 19.5) compared to 0.2mm (SD 7.3) in the
Lymphoseek group (p =0.0002). Overall, patients receiving
Lymphoseek experienced statistically significant less change in
pain scores compared to patients receiving fTcSC at 1-3 minutes
post-injection.
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.
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 diagnostics, therapeutics and
radiopharmaceutical agents. 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 radiopharmaceutical agents and
therapeutics, 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/20150608006395/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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