Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) is announcing
the receipt of an initial notice of award for a Fast Track Small
Business Innovation Research (SBIR) grant providing for up to $1.8
million from the National Cancer Institute (NCI), National
Institutes of Health (NIH), to fund preclinical studies examining
the safety of intravenous(IV) injection of Tc99m tilmanocept, a
Manocept™ platform product, followed by a clinical study providing
the initial evaluation of the safety and efficacy of SPECT imaging
studies with IV Tc99m tilmanocept to identify and quantify both
skin- and organ-associated KS lesions in human patients.
The SBIR grant is awarded in two parts with the potential for
total grant money of up to $1.8 million over two and a half years.
The first six-month funding segment of $300,000, which has already
been awarded, is expected to enable Navidea to secure necessary
collaborations and Institutional Review Board (IRB) approvals. The
second funding segment could provide for up to an additional $1.5
million to be used to accrue participants, perform the Phase 1/2
study and perform data analyses to confirm the safety and
effectiveness of intravenously administered Tc99m tilmanocept.
“We appreciate the recurring support by the NIH which we believe
reflects, in part, their confidence in the strength of our clinical
development capabilities. This study reinforces our commitment to
support the expanded use of Lymphoseek® (technetium Tc99m
tilmanocept) injection to help patients afflicted with other solid
tumor cancers,” said Michael Tomblyn, M.D., Navidea’s Chief Medical
Officer. “Positive outcomes showing that intravenously injected
Tc99m tilmanocept localizes specifically and at detectable levels
in KS lesions would open the possibility that a Manocept-drug
conjugate might be used to target delivery of therapeutics to KS
lesions.”
“Building on earlier research showing KS tumor cells abundantly
express CD206, the tilmanocept receptor, and successful imaging
with subcutaneous injection, we plan to evaluate intravenous
administration of this targeted imaging agent to noninvasively
locate internal KS lesions, which are currently challenging to
identify and monitor,” commented Toby Maurer, M.D., FAAD, Professor
of Dermatology at the University of California, San Francisco
(UCSF), and Chief of Dermatology at San Francisco General Hospital
and Trauma Center, who is co-PI at UCSF with Michael S. McGrath,
M.D., PhD. “If successful, future diagnostic and eventually
therapeutic developments have the potential to dramatically improve
life expectancies and quality of life for patients suffering from
Kaposi’s sarcoma.”
About the Preclinical animal studies
Preclinical animal studies and laboratory test development will
investigate the feasibility and support clinical protocol
development for intravenous administration of Tc99m tilmanocept in
human patients with KS and will include method development and
validation for dose solution analysis and various pharmacology,
pharmacokinetic and toxicology analysis in animals.
About the Phase 1/2 Clinical Study
This study has been designed as a single center, open-label,
non-randomized, Phase 1/2 Clinical Study to evaluate intravenous
injection of Tc99m tilmanocept into KS patients. The study, using
imaging with single-photon emission computed tomography (SPECT) and
likely, SPECT/CT, will evaluate the ability of Tc99m tilmanocept to
identify KS lesions and bind to CD206 on KS cells and their
tumor-associated macrophages (TAMs). Various doses of Tc99m
tilmanocept will be evaluated. The study is expected to involve up
to 48 patients with HIV- or transplant-associated KS and last 2
years. The goal of the study is to provide evidence evaluating the
safety and efficacy as well as optimal dosing and timing of Tc99m
tilmanocept as a SPECT imaging agent for KS lesions.
About Kaposi’s Sarcoma
Kaposi sarcoma (KS) is a cancer that develops from the cells
that line lymph nodes or blood vessels. It usually appears as
tumors on the skin or on mucosal surfaces such as inside the mouth,
but tumors can also develop in other parts of the body, such as in
the lymph nodes (bean-sized collections of immune cells throughout
the body), the lungs, or digestive tract. The abnormal cells of KS
form purple, red, or brown blotches or tumors on the skin. These
affected areas are called lesions. The skin lesions of KS most
often appear on the legs or face. AIDS-related KS is the most
common type of KS in the United States and develops in people who
are infected with HIV, the virus that causes AIDS. KS can also
develop in people whose immune systems have been suppressed after
an organ transplant and is called transplant-related KS.1
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
Navidea 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 American Cancer Society web accessed 22May2015.
http://www.cancer.org/cancer/kaposisarcoma/detailedguide/kaposi-sarcoma-what-is-kaposi-sarcoma
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.
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Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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