- Also notified of release of $3.2 million in
funding for parts 2 & 3 of previously awarded SBIR grants in
support of clinical studies for cervical cancer and Alzheimer’s
Disease -
Navidea announces the receipt of an initial notice of award for
a Fast Track Small Business Innovation Research (SBIR) grant
providing for up to $1.7 million from the National Institutes of
Health’s (NIH) National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMD), to fund preclinical animal studies and a
Phase 1/2 human clinical study examining the ability of Tc
99m-tilmanocept, a Manocept™ platform product, to identify skeletal
joints that are inflamed due to rheumatoid arthritis (RA). RA is a
chronic, progressive, systemic autoimmune disease characterized by
inflammation of numerous skeletal joints. If not treated
successfully, RA can lead to disability, disfigurement and
premature death.
The funds for this Fast Track grant will be released in two
parts, which together have the potential to provide a total of $1.7
million in resources over 2.5 years to achieve the specific aims
and objectives of the grant. The first part will provide $225,000
to support preclinical animal studies and to support activities
needed to prepare for the Phase 1/2 clinical study. The second part
of the award will support the Phase 1/2 study, the results from
which are expected to confirm the safety and effectiveness of Tc
99m-tilmanocept to identify skeletal joint inflammation due to
RA.
“Because the therapies for RA are most effective when given
early in the course of the illness, improved ability for accurate,
early diagnosis along with more accurate monitoring of therapies
could lead to improved patient outcomes,” commented Michael
Tomblyn, M.D., Navidea’s Chief Medical Officer. “This grant will,
as a follow on to other successful pre-clinical work, enable human
evaluation for the first time of the IV administration of
tilmanocept to identify peripheral skeletal joints that are
inflamed as a result of ongoing RA pathology and to differentiate
RA from osteoarthritis patients.”
“Developing future medical applications which unlock the
potential for our CD206-targeting imaging agent, tilmanocept, is a
corporate priority,” said Frederick O. Cope, Ph.D., FACS, Chief
Scientific Officer of Navidea. These studies will broaden the use
of the Manocept platform to other potential macrophage-associated
diseases and will evaluate a new approach to tilmanocept delivery
with future implications in therapeutic development.
About the Phase 1/2 Clinical Study EffortsThis study has
been designed as a single center, open-label, non-randomized, Phase
1/2 Clinical Study of 44 individuals to investigate the ability of
Tc 99m-tilmanocept to identify RA inflamed joints and to identify
early RA patients among those with polyarthralgia/polyarthritis
(P/P). There is intent to study three groups of subjects:
participants with active RA, participants with recent development
of P/P or healthy, arthritis free individuals over the age of 50.
If this project is successful, follow on studies will investigate
if tilmanocept can be used to target delivery of therapeutics to RA
inflamed joints thereby increasing the potential effectiveness of
treatments.
Updates on Additional SBIR GrantsIn addition to this new
award for RA, Navidea recently received confirmation of funding
parts 2 and 3 of previously awarded NIH SBIR grants supporting
clinical studies for Lymphoseek in cervical cancer ($1.5 million)
and for NAV4694 in Alzheimer’s Disease and Mild Cognitive
Impairment ($1.7 million).
About Rheumatoid ArthritisRA is a chronic, progressive,
systemic autoimmune disease affecting about 1.3 million1 in the US
and is characterized by inflammation of numerous skeletal joints.
If not treated successfully, RA can lead to disability,
disfigurement and premature death. The recent advent of
disease-modifying anti-rheumatic drugs (DMARDs) has dramatically
improved outcomes for many RA patients. Three problems persist:
DMARDs are most effective when RA symptoms first appear and current
technologies for diagnosing RA are least accurate; monitoring the
effectiveness of DMARD therapy is challenging; and a significant
portion of RA patients respond poorly or not at all to current
DMARDs. Therefore, there are significant unmet medical needs for a
more accurate RA diagnosis, especially in the early stages of the
disease, and for more effective RA therapies.
About the Manocept™ CD206-targeting platformThe 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. This flexible and versatile platform acts as an
engine for purpose-built molecules that may enhance diagnostic
accuracy, clinical decision-making, targeted treatments and
ultimately patient care. As a diagnostic tool, the Manocept
technology has the potential to utilize a breadth of imaging
modalities, including SPECT, PET, intra-operative and/or
optical-fluorescence detection. By adding a therapeutic agent on
the Manocept molecular backbone, there is the potential to develop
novel, targeted immunotherapies specifically designed to
selectively deliver an agent that can kill or alter
disease-associated macrophages. Navidea’s FDA-approved precision
diagnostic imaging agent, Lymphoseek® (technetium 99m tilmanocept)
injection, is representative of the platform’s ability to
successfully exploit this mechanism and offer the potential for
development of new CD206-targeted diagnostic agents and
therapeutics.
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
InformationLymphoseek 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 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.
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 NavideaNavidea Biopharmaceuticals, Inc. (NYSE MKT:
NAVB) is a biopharmaceutical 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™ 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. 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.
1 Helmick CG, Felson DT, Lawrence RC, et al. Estimates of the
prevalence of arthritis and other rheumatic conditions in the
United States- Part I. Arthritis & Rheum. 2008: 58(1):15-25.
Information available at
http://www.rheumatology.org/ACR/about/newsroom/prevalence/prevalence-one.pdf
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version on businesswire.com: http://www.businesswire.com/news/home/20150729005400/en/
Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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