- Studies to be initiated in a variety of
disease models in animals -
Macrophage Therapeutics, Inc., a subsidiary of Navidea
Biopharmaceuticals, Inc. (NYSE MKT:NAVB), today announces that it
has developed a process for producing the first two therapeutic
Manocept™ immunoconstructs, MT-1001, designed to specifically
target and kill activated CD206+ macrophages and MT-2001, designed
to inhibit the inflammatory activity of activated CD206+
macrophages. Activated CD206+ macrophages are implicated in
numerous diseases ranging from cancer to autoimmune diseases to CNS
diseases like Alzheimer’s disease and multiple sclerosis.
MT-1001 and MT-2001 were developed from the Manocept™ platform
technology and contain a similar chemical scaffold and targeting
moieties designed to selectively target CD206+ macrophages. A
payload of a therapeutic molecule is conjugated to each
immunoconstruct through a linkage that will release the molecule
within the targeted tissue: MT-1001 has doxorubicin, an
anthracycline antitumor antibiotic, conjugated to the Manocept
backbone and MT-2001 has a potent anti-inflammatory agent
conjugated to it. The FDA approved product Lymphoseek® (technetium
Tc 99m tilmanocept) injection marketed by Navidea, was developed
using the same CD206 targeting technology. Macrophage Therapeutics
has contracted with an independent facility to produce sufficient
quantities of MT-1001 and MT-2001 along with the concomitant
analytical standards, to provide material for planned preclinical
animal studies.
In addition, the Company announces the launch of its new web
site www.macrophagetx.com. Visit the
new site to learn more about the Manocept platform technology, our
scientific trials, study data being generated, and to contact us
about potential development and partnering opportunities. We plan
to regularly update the website as results are generated
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 Macrophage Therapeutics
Macrophage Therapeutics, Inc., a subsidiary of Navidea
Biopharmaceuticals, Inc. (NAVB), is developing therapeutics using
the patented Manocept immunotherapy platform licensed from Navidea
to target over-active macrophages implicated in cancer,
cardiovascular, central nervous system, autoimmune, antiviral, and
skin diseases. Manocept specifically targets CD206, or the mannose
receptor prevalent on over-active macrophages. The technology
enables highly specific targeted delivery of active (either
existing or yet to be developed) agents that can modulate the
activity of over-active macrophages that have been implicated in
many diseases. Targeted delivery should significantly enhance a
given compound’s efficacy and safety.
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150925005134/en/
Macrophage TherapeuticsJames Goldschmidt, Ph.D.,
484-225-0341jgoldschmidt@macrophagetx.comorNavidea
BiopharmaceuticalsFor Investors:Tom Baker,
617-532-0624tbaker@navidea.comorFor Media:Sharon Correia,
978-655-2686Associate Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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