Independent Investigators Report Lymphoseek® Results in JAMA Otolaryngology
Head and Neck Surgery
- Publication Details Findings of Phase 3 Clinical Trial of Lymphoseek in Head
and Neck Cancer at The Ohio State University -
DUBLIN, Ohio -- September 19, 2013
Navidea Biopharmaceuticals, Inc. (NYSE:NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, announced today that
results from the Phase 3 clinical trial of Lymphoseek^® (technetium Tc 99m
tilmanocept) Injection in Head and Neck Cancer (NEO3-06) at The Ohio State
University Comprehensive Cancer Center – James Cancer Hospital & Solove
Research Institute were published in the current edition of the peer-reviewed
journal, JAMA Otolaryngology Head and Neck Surgery, a publication of the
American Medical Association.
The publication, “Use of a Novel Receptor-Targeted (CD206) Radiotracer,
99m-Tc-Tilmanocept, and SPECT/CT for Sentinel Lymph Node Detection in Oral
Cavity Squamous Cell Carcinoma: Initial Institutional Report in an Ongoing
Phase 3 Study,” describes the experience at one of the clinical trial sites
that participated in NE03-06, a Phase 3 study designed to assess the potential
utility of Lymphoseek as a sentinel lymph node mapping agent in patients with
head and neck cancer.
“The results, published independently by this single clinical trial site in
our larger Phase 3 NE03-06 study, corroborate data for the ability of
Lymphoseek to identify sentinel lymph nodes in head and neck squamous cell
carcinoma,” said Mark Pykett, VMD, PhD, CEO of Navidea. “As Navidea previously
announced, Lymphoseek met the primary endpoint in the NE03-06 trial, where it
correctly identified pathology-positive lymph nodes in 38 of 39 patients,
demonstrating a statistically significant overall False Negative Rate of 2.56
percent. We look forward to additional presentations of the broader dataset
from our NE03-06 Phase 3 clinical trial in the coming months. We have closed
the study following a constructive FDA meeting and with the recommendation of
the Data Safety Monitoring Committee. Based on the NEO3-06 study results and
data analysis, we are working to file an sNDA for Lymphoseek by year end.”
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.
Accurate diagnostic evaluation of cancer is critical, as it guides therapy
decisions and determines patient prognosis and risk of recurrence. According
to the American Cancer Society, approximately 232,000 new cases of breast
cancer, 77,000 new cases of melanoma and 67,000 new cases of head and
neck/oral cancer are expected to be diagnosed in the United States in 2013.
Indication and Important Safety Information About Lymphoseek
Lymphoseek (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 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
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
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.LYMPHOSEEK.COM
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 actively developing
four radiopharmaceutical agent platforms – Lymphoseek® (technetium 99m
tilmanocept) Injection, NAV4694, NAV5001 and RIGScanTM – to help identify the
sites and pathways of undetected disease and enable better diagnostic
accuracy, clinical decision-making and, ultimately, patient care. Navidea’s
first commercial agent, Lymphoseek, 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
Brent Larson, 614-822-2330
Executive VP & CFO
Stern Investor Relations, Inc.
Beth DelGiacco, 212-362-1200
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