Lymphoseek® Reduces Sentinel Lymph Node Biopsy Imaging Time, Facilitating Patient Throughput and Workflow Efficiencies
December 03 2015 - 8:29PM
Business Wire
- Data from Time-Efficiency Study Presented at
RSNA2015 -
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) today announced
that results from an investigator-initiated imaging study
demonstrated Lymphoseek® (technetium Tc 99m tilmanocept) injection
reduced imaging time by more than 50% in sentinel lymph node biopsy
procedures in malignant melanoma compared to Tc99m sulfur colloid
(SC). This finding suggests hospitals and oncology treatment teams
can achieve greater patient throughput and workflow efficiencies
utilizing Lymphoseek. Results of the study, conducted at the Thomas
Jefferson University Hospitals and led by Charles M. Intenzo, M.D.,
Professor of Radiology, Director, Nuclear Medicine and Molecular
Imaging in the Department of Radiology were presented today at the
Radiological Society of North America Annual Meeting (RSNA 2015) in
Chicago, Illinois.
“This study continues to support our belief in the clinical
value of Lymphoseek for physicians and patients and also
introduces an operational efficiency that strengthens the value to
the hospital and the overall patient experience,” commented
Michael Tomblyn, M.D., Navidea’s Chief Medical Officer. “Based on
the ability to rapidly clear from the injection site and transit to
tumor-draining lymph nodes, we believe that Lymphoseek may
facilitate more efficient resource utilization including
predictable scheduling of lymphatic mapping procedures, associated
personnel and resources.”
A total of 34 consecutive patients with malignant melanoma
underwent Sentinel Lymph Node (SLN) mapping with Lymphoseek.
Patients received the Lymphoseek dose in 4 intradermal
administrations around the tumor site. Images were acquired at
intervals up to 40 minutes after injection, which is the
department’s standard-of-care protocol used for Tc99m Sulfur
Colloid (SC) procedures. This site’s previous experience showed
that SC injections required 40 to 45 minutes after injection for
visualization of all lymph nodes in patients with malignant
melanoma. Using Lymphoseek, the results show that in all 34
patients, all lymph nodes seen in the final 40-minute image were
identified in the 20-minute image, providing rapid and stable
localization and identification of the sentinel nodes. The study
concludes that in malignant melanoma, SLN mapping with Lymphoseek
involves a total imaging time of 20 minutes which is one-half of
the time required for Tc99m SC. From a clinical perspective, the
authors conclude that utilizing Lymphoseek is more time-efficient
than SC by facilitating patient throughput and expediting
subsequent transport to the operating room.
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 immuno-diagnostic agents and
immuno-therapeutics. 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.
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Investors are cautioned that such statements involve risks and
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including, but not limited to, the Company’s continuing operating
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Company’s most recent Annual Report on Form 10-K and other
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Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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