Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) announced that
it has received Institutional Review Board (IRB) approval from the
University of California, San Francisco School of Medicine for a
clinical study examining the ability of Lymphoseek®(technetium Tc
99m tilmanocept) injection, a Manocept™ platform product, to
specifically identify active rheumatoid arthritis (RA) in
pre-identified RA-affected joints. The study will begin enrolling
patients shortly. Additionally, Navidea has received WIRB IRB
approval to expand this study to other study sites at Navidea’s
discretion.
“This IRB approval is an important and significant advancement
in the expansion of the Manocept platform as we can now start
enrollment in this seminal RA immunodiagnostic study.” said
Frederick O. Cope, Ph.D., Chief Scientific Officer of Navidea. “We
believe in the medical value of Manocept platform to enhance the
specific diagnosis of inflammatory and infectious diseases to
benefit patient care and guide treatment.”
About the RA Clinical Study
This study has been designed as an open-label, Phase 1 clinical
study of up to 18 individuals to investigate the ability of a
subcutaneous injection of Tc 99m-tilmanocept to identify RA
inflamed joints in active RA subjects by SPECT and SPECT/CT
imaging. The study will enroll four cohorts of subjects:
participants with active RA and arthritis-free individuals
evaluating two different tilmanocept doses in each group. Results
of this study will be used to determine tilmanocept’s ability to
localize in subjects with RA and show concordance with clinical
symptoms, compare the intensity between the two dose groups, and
compare localization between active RA and arthritis-free subjects.
Study results will help to inform the trial design for follow-on
studies. This study is supported by NIH/NIADDK grant
number:1R44AR067583-01A1.
Study details can be found at:
https://clinicaltrials.gov/ct2/show/NCT02683421?term=lymphoseek&rank=11.
About Rheumatoid Arthritis
RA is a chronic disease affecting 1.6 million in the US. The
immune system plays an important role in RA. Cells of the immune
system invade tissues that line the joints (the synovium), causing
inflammation and over time damage the cartilage and bone. It can
lead to long-term joint damage, resulting in chronic pain, loss of
function and severe disability. RA can be hard to detect because it
may begin with subtle symptoms, such as achy joints or a little
stiffness in the morning. Also, many diseases behave like RA early
on. There is no single test that confirms an RA diagnosis.
Currently there is no approach to reliably detect, evaluate or
therapeutically target the macrophage inflammatory component which
is a key driver of progression. Misdiagnosis results in billions of
dollars being spent each year unnecessarily on therapies, which may
also result in significant side effects.
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.
UC Disclaimer
The information stated above was prepared by Navidea
Biopharmaceuticals, Inc. and reflects solely the opinion of the
corporation. Nothing in this statement shall be construed to imply
any support or endorsement of Navidea or any of its products, by
The Regents of the University of California, its officers, agents
and employees.
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, our
ability to repay our debt, the outcome of the CRG litigation,
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 The Company undertakes no obligation to publicly
update or revise any forward-looking statements.
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Navidea BiopharmaceuticalsInvestors &
MediaSharon Correia, 978-655-2686Senior Director, Corporate
Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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