High concordance between preoperative and
intraoperative findings noted in data from patients with head and
neck oral cavity squamous cell carcinoma
Outcome analysis from melanoma and breast
cancer patients using Lymphoseek indicates accurate sentinel node
detection
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today
announced that data from its Lymphoseek® (technetium Tc 99m
tilmanocept) injection studies in melanoma, breast and oral cavity
squamous cell cancers (SCC) will be presented at the 68th Annual
Cancer Symposium of the Society of Surgical Oncology (SSO) meeting
held in Houston, TX, March 25-28, 2015.
An oral presentation by Douglas Chepeha, M.D. of the University
of Toronto-Princess Margaret Hospital reveals that analysis from
Phase 3 data for detection of sentinel lymph nodes (SLN) in head
and neck oral cavity squamous cell carcinoma patients demonstrated
high concordance between preoperative lymphoscintigraphy and
intraoperative SLN biopsy findings. Notably, 95.2% of patients had
agreement between their preoperative (by imaging) and
intraoperative (by handheld gamma-probe) findings. This high
concordance when using Lymphoseek confirms its role in the utility
of preoperative lymphoscintigraphy imaging for planning and
conducting SLN biopsy.
Results of a follow-up outcome study presented as a poster by
Julian Kim, M.D. of the University Hospitals Seidman Cancer Center
indicated that in patients who were confirmed to be node-negative
(N0) after sentinel lymph node biopsy (n=89; 57 breast cancer, 32
melanoma) the regional recurrence-free rate (RRFR) was 98.8% (100%
in breast cancer; 97.4% in melanoma) at three years. An overall
false negative rate (FNR) for the two tumor types was 5.6% and the
negative predictive value (NPV) was 98.6% (100% in breast cancer;
96.4% in melanoma). These results demonstrate that Lymphoseek
accurately identified SLNs and is likely predictive of pathological
staging.
Presentation Details
Date: March 28, 2015 Type: Oral Title:
Lymphoscintigraphy Concordance with
Intraoperative Findings from Sentinel Lymph Node (SLN)Biopsy with
[99mTc] Tilmanocept in Clinically Node-negative (cN0) Head and Neck
Squamous CellCarcinoma Patients (HNSCC)
Authors:
D. Chepeha,(1) A. Agrawal,(2) F.J.
Civantos,(3) S.Y. Lai,(4.) 1. Otolaryngology, University ofToronto
- Princess Margaret Hospital, Toronto, ON, Canada; 2. The Ohio
State University,Columbus, OH; 3. University of Miami Hospitals and
Clinics, Miami, FL; 4. MD Anderson CancerCenter, Houston, TX.
Date: March 26, 2015 Type: Poster Title:
False Negative Rate (FNR) and Negative
Predictive Value (NPV) from 3-year Outcome Study afterSentinel
Lymph Node Biopsy (SLNB) with [99mTc] Tilmanocept in Clinically
Node-negative (cN0)Breast Cancer and Melanoma Patients
Authors:
J. Kim, J.K. O'Donnell, Division of
Surgical Oncology, Department of Surgery, Case WesternReserve
University, Cleveland, Ohio
About ILM and Lymphoscintigraphy
To date, Lymphoseek is the first and only receptor-targeted
agent developed specifically for Intraoperative Lymphatic Mapping
(ILM). ILM is a surgical oncology procedure in which lymph nodes
draining the area around a tumor are identified and biopsied to
determine if cancer has spread to the lymph nodes.
Lymphoscintigraphy is an imaging procedure routinely performed
pre-operatively to provide surgeons with guidance on the relative
location of lymph nodes to be biopsied. ILM with a
radiopharmaceutical is specifically intended to identify for the
surgeon the first lymph node(s), called Sentinel Lymph Nodes (SLN),
to receive lymphatic flow from the primary tumor site. SLNs are
removed and analyzed for the presence of malignant cells. By
identifying the SLNs prior to surgery, a small incision and focused
dissection can be used to remove the node. This technique provides
an accurate staging procedure that spares patients who are negative
for lymph node metastasis by SLN biopsy the morbidity of a complete
lymph node dissection.
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 Biopharmaceuticals Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) is a commercial
stage precision medicine 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™,
NAV4694, and NAV5001, 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 by the EMA 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.
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOOrSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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