Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a
biopharmaceutical company focused on precision diagnostic
radiopharmaceuticals, today announced that data and results from
its Lymphoseek® (technetium Tc 99m tilmanocept) Injection studies
in breast cancer, melanoma or head and neck cancer and its
Manocept™ studies in Rheumatoid Arthritis and Kaposi Sarcoma are
being presented at the Society of Nuclear Medicine and Molecular
Imaging Annual Meeting from June 7-14, 2014 in St. Louis, MO.
Details of the eleven presentations by Navidea and its
collaborators are listed below.
Date:
June 8, 2014
Poster Title:
Fluorescent CD206-targeted Manocept-Cy3
(Mano-Cy3) specifically localizes on macrophages (MPs) derived from
rheumatoid arthritis (RA) patients' synovial fluid & is
quantitatively greater than that from non-RA patients.
Presenter: Wael Jarjour, The Ohio State Univ. Wexner Medical
Center, Columbus, OH Poster Section:
Cardiovascular, Endocrine, Other
Posters
Poster Title:
lntravenous administration (lV) of the
CD206-targeted Manocept-Cy3 (Mano-Cy3) to mice with induced
rheumatoid arthritis (RA) results in heterogeneous localization of
Mano-Cy3 with strong specificity for RA-expressing joints.
Presenter: Thomas Rosol, The Ohio State University. College of
Veterinary Medicine, Columbus, OH Poster section:
Cardiovascular, Endocrine, Other
Posters
Date:
June 9, 2014
Poster Title:
CD206-targeted Cy3-Manocept (Mano-Cy3)
localizes in nearly all cells present in Kaposi's sarcoma
representing an opportunity for dynamic imaging, local staging and
a potential for visceral metastasis imaging.
Presenter: Michael McGrath, AIDS & Cancer Specimen Resource,
San Francisco, CA Poster section:
Sarcoma/Melanoma Posters
Poster Title:
99mTc-Tilmanocept provides a zero-false
negative rate (FNR) and accurate staging when used in ex vivo
sentinel node (SLNB) evaluation of a pilot cohort of colorectal
cancer patients (CRCP).
Presenter: Daniel Sherwinter, The Maimonides Medical Center,
Brooklyn, NY Poster section:
GI-Colorectal & Liver
Posters
Poster Title:
CD206 receptor-targeted 99mTc-Tilmanocept
is equally effective in detection of sentinel lymph nodes (SLNs) in
breast cancer (BC), melanoma (ME), and head/neck squamous cell
carcinoma (HNSCC) with ≥99% accuracy.
Presenter: Michael Blue, Navidea Biopharmaceuticals, Dublin, OH
Poster section:
Head and Neck Posters
Poster Title:
A 3-year follow-up study of breast cancer
(BC) or melanoma (ME) patients (Pts) who underwent sentinel node
biopsy (SLNB) indicates a < 2% false negative rate performance
with CD206 receptor-targeted 99mTc-tilmanocept as the sole
intraoperative lymphatic mapping agent.
Presenter: Joanna Shuping, Navidea Biopharmaceuticals, Dublin, OH
Poster section:
Breast Cancer Poster Session
Poster Title:
The use of 99mTc-tilmanocept efficacy for
sentinel lymph node biopsy (SLNB) with surgery the same day of
injection (SDI) or surgery the day after injection (DAI) does is
not different across multiple solid tumors.
Presenter: David Colborn, Navidea Biopharmaceuticals, Dublin, OH
Poster section:
Head and Neck Posters
Poster Title:
The high sensitivity (SEN) of
99mTc-Tilmanocept is unaffected by injection route and interval
from injection to surgery across solid tumor types [breast cancer
(BC), melanoma (ME) & head/neck squamous cell carcinoma
(HNSCC)].
Presenter: Frederick Cope, Navidea Biopharmaceuticals, Dublin, OH
Poster section:
Breast Cancer Poster Session
Date:
June 10, 2014
Oral Title:
The CD206-targeted, macrophage
(MP)-localizing 99mTc-tilmanocept is accrued ~3-times greater in
tumor-positive sentinel lymph nodes (SLNs) than tumor-negative SLNs
and 18-times greater than non-SLNs.
Presenter: Frederick Cope, Navidea Biopharmaceuticals, Dublin, OH
Sc. Paper section:
Head and Neck I
Date:
June 11, 2014
Oral Title:
A pooled assessment of 384 patients with
breast cancer, melanoma or squamous cell carcinoma of the head/neck
(cutaneous and oral) shows a false negative rate for identifying
pathology-positive lymph nodes of less than two-percent when CD206
receptor-targeted 99mTc-tilmanocept is used as a single agent.
Presenter: Bonnie Abbruzzese, Navidea Biopharmaceuticals, Dublin,
OH Sc. Paper section:
Sarcoma/Melanoma
Oral Title:
A pooled assessment of the per patient
negative predictive value (NPV; n=286) and positive predictive
value (PPV; n=98; based on histological localization) for patients
with breast cancer or melanoma or squamous cell carcinoma of the
head/neck (cutaneous and oral) shows that no single metric has less
than 99-percent performance for CD206-targeted
99mTc-Tilmanocept.
Presenter: Cornelia Reininger, Navidea Biopharmaceuticals, Dublin,
OH Sc. Paper section:
Breast Cancer I
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 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 supplemental new drug application (sNDA) for sentinel lymph
node detection in patients with head and neck cancer.
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
LymphoseekIndicationLymphoseek (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 InformationIn 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 the Manocept™ PlatformNavidea’s Manocept platform
is predicated on the ability to specifically target the CD206
mannose receptor expressed on macrophages. Macrophages play
important roles in many disease states and are an emerging target
in many disorders where diagnostic uncertainty exists. This
flexible and versatile platform acts as an engine for purpose-built
molecules that may enhance diagnostic accuracy, clinical
decision-making and ultimately patient care, while offering the
potential to utilize a breadth of diagnostic imaging modalities,
including SPECT, PET, intra-operative and/or optical-fluorescence
detection. The Company’s FDA-approved precision diagnostic
lymphatic mapping agent, Lymphoseek® (technetium 99m tilmanocept)
Injection, is representative of the ability to successfully exploit
this mechanism to develop powerful, new diagnostic agents.
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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