– Data from three investigator-initiated
studies reported at the Annual Meeting of the Society of Nuclear
Medicine and Molecular Imaging –
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), today
announced results from three investigator-initiated studies that
demonstrate beneficial performance characteristics of Lymphoseek®
(technetium Tc 99m tilmanocept) injection and positive comparative
results versus commonly-used, non-receptor-targeted imaging agents.
The data were presented by the investigators this week at the 2016
Annual Meeting of the Society of Nuclear Medicine and Molecular
Imaging (SNMMI) in San Diego, CA.
“These data further reinforce the beneficial clinical
performance attributes of Lymphoseek® (technetium Tc 99m
tilmanocept) Injection. And, in addition, they support Lymphoseek’s
rapid adoption in sentinel lymph node biopsy procedures and its
pre-surgical imaging utility for other solid tumors,” commented
Michael Blue, M.D., Senior Medical Director of Navidea. “We believe
results from these and other performance-based studies will
encourage surgeon’s to use Lymphoseek as they look to optimize
outcome for their patients and improve patient experience.”
Experimental Results
In the presentation entitled, “Performance of Tc-99m tilmanocept
when used alone is as or more effective in localizing sentinel
nodes than sulfur colloid plus blue dye,” Jonathan Unkart and Anne
Wallace, M.D., Department of Surgery at the University of
California San Diego (UCSD), described a retrospective evaluation
of the rate of localization of Lymphoseek when used alone compared
to sulfur colloid (SC), blue dye (BD) and SC plus BD. The study
included results from 148 breast cancer patients evaluated in two,
prospective Phase 3 Lymphoseek clinical trials (data published in
Annuls of Surgical Oncology 2013). SC and BD data was derived from
a literature search presented at SNMMI 2013 Annual Meeting
including treatment groups of 17,814 SC alone, 12,821 BD alone and
19,627 SC+BD patients. Results show the following localization
rates: Lymphoseek alone: 0.9865, SC alone: 0.9249, BD alone: 0.8294
and SC+BD: 0.9636. The author’s analysis suggests that Lymphoseek
provided superior sentinel lymph node localization in breast cancer
patients compared to the other non-targeting agents alone or in
combination providing surgeons the option to use just a single
agent.
The presentation, “Use of lymphoscintigraphy with Tc-99m
tilmanocept does not affect the number of nodes removed during
sentinel node biopsy (SLNB) in breast cancer,” also presented by
Dr. Unkart shows data from a retrospective review evaluating
whether there is a difference in the number of nodes removed using
Lymphoseek during SLNB in patients who had a pre-operative imaging
procedure called lymphoscintigraphy prior to SLNB versus those who
only had intra-operative Sentinel Node (SN) identification. The
results indicate that in Breast Cancer, identification and removal
of SNs using lymphoscintigraphy (3.0 SNs) did not significantly
alter the number of SLNs removed during a SLNB procedure with no
imaging (2.7 SNs). Lymphoseek’s selective-targeting performance
characteristic enables the utilization of only a single dose of
Lymphoseek per patient irrespective of whether both
lymphoscintigraphy and SLNB are performed. The authors concluded
that by using Lymphoseek, lymphoscintigraphy imaging procedures may
be eliminated in this patient population and may reduce health care
cost without impacting patient outcomes.
The presentation entitled, “Rate of sentinel lymph node
visualization in fatty breasts: Tc-99m Tilmanocept versus Tc-99m
filtered sulfur colloid,” describes results from a study at Emory
University School of Medicine using Lymphoseek in patients with
fatty breast tissue a population that is known to be more difficult
to localize nodes when doing SLNB. The results suggest that
Lymphoseek more effectively visualized sentinel lymph nodes (SLN)
both on lymphoscintigraphy and during surgery compared to filtered
sulfur colloids (Tc-SC) with 100% localization using Lymphoseek
intraoperatively. Dr. Maryam Shahrzad, M.D. presented retrospective
data compiled from 29 consecutive patients with early stage breast
cancer where lymphoscintigraphy was performed using Tc-SC and 28
patients where lymphoscintigraphy was performed using Lymphoseek.
Multiple patient variables were recorded. The Tc-SC cohort included
96% of patients with fatty breasts versus 89% in the Lymphoseek
group. Statistically significant findings included:
- In lymphoscintigraphy, SLN
visualization occurred in 86% of the Lymphoseek group compared to
59% of the TC-SC group. (p-value: 0.02)
- At surgery, 100% of patients in the
Lymphoseek group showed a “hot” SLN compared to only 79% of
patients in the Tc-SC group. (p-value: 0.01)
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. The
development activities of the Manocept immunotherapeutic platform
will be conducted by Navidea in conjunction with its subsidiary,
Macrophage Therapeutics. 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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forward-looking The Company undertakes no obligation to publicly
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Investors & MediaNavidea Biopharmaceuticals,
Inc.Sharon Correia, 978-655-2686Senior Director, Corporate
Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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