Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), today
announced the receipt of an initial notice of award for a Fast
Track Small Business Innovation Research (SBIR) grant providing for
up to $1.67 million from the National Cancer Institute (NCI),
National Institutes of Health (NIH), to fund evaluation of
Lymphoseek® (technetium Tc 99m tilmanocept) Injection in women with
cervical cancer. The multicenter, clinical study in patients with
early cervical cancer will seek to assess and provide data in
support of the use of Lymphoseek in sentinel lymph node biopsy
(SLNB) procedures which identify and evaluate the lymph nodes most
likely to harbor additional cancer.
The SBIR grant is awarded in two parts with the potential for
total grant money up to a total of $1.67 million over two and a
half years. The first six-month funding segment of $165,917, which
has already been awarded, is expected to enable Navidea to identify
and qualify trial sites and secure necessary contracts 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 sentinel lymph node (SLN)
procedures and pathology evaluations; and perform data analyses to
confirm the safety and effectiveness of Lymphoseek.
“UC San Diego Moores Cancer Center played a key role in
tilmanocept's Phase 1-3 clinical evaluation for sentinel lymph node
assessment in melanoma, breast cancer and squamous cell carcinoma
of the head and neck," said Michael T. McHale, M.D., Associate
Professor, Fellowship Director, Division of Gynecologic Oncology,
UC San Diego Moores Cancer Center. "There is currently a growing
focus on sentinel lymph node biopsy (SLNB) procedures in
gynecologic cancers. We are pleased to participate in this
important study which will evaluate and compare the abilities of
tilmanocept and an alternative detection agent to identify SLNs
during cervical cancer surgery. If successful, this study could
potentially advance the use of SLNB procedures in cervical
cancer.”
“We appreciate NCI’s support as we seek to further broaden the
Lymphoseek label which is currently indicated for use in lymphatic
mapping for breast cancer and melanoma, and to guide Sentinel Lymph
Node Biopsy in certain head and neck cancers," said Frederick O.
Cope, Ph.D., F.A.C.N., C.N.S Senior Vice President and Chief
Scientific Officer of Navidea. "The current standard of care in
cervical cancer surgery is to remove in excess of 20 lymph nodes
which often leads to more extensive, complex and costly surgical
procedures as well as potentially to serious post-surgical
complications and morbidity. By accurately and reliably identifying
the first lymph nodes draining a tumor, Lymphoseek may provide
surgeons important disease staging information that can guide
treatment decisions and improve patient outcomes.”
“This study is an excellent example of how we intend to support
the expanded use of Lymphoseek to help patients afflicted with
other solid tumor areas,” said Michael Goldberg, M.D., Navidea
Interim CEO. “With 3-4 million new solid tumors each year in the US
and Europe, this and other studies will help establish and
standardize surgical methods and SLN procedures with the goal to
establish Lymphoseek as a new standard of care for guiding patient
treatment.”
This study is designed as a multicenter, open-label,
within-patient comparative study of Lymphoseek and an alternative
lymphatic mapping agent referred to as vital blue dye for detection
of lymph nodes in patients with cervical cancer. The study, using
lymphatic mapping and SLN biopsy procedures, will compare the
abilities of Lymphoseek and the alternative agent to identify SLNs
during cervical cancer surgery. Additionally, the sentinel node
pathology will be contrasted between agents and between the
pathology of other nodes that may be removed during the procedure
(non-sentinel nodes). The study is expected to involve 40 patients
and last 1.5 years.
About Cervical CancerCervical cancer is usually a
slow-growing cancer that affects ~12,000 new patients each year in
the U.S. Worldwide, the World Health Organization notes that
cervical cancer is both the fourth most common cause of cancer and
the fourth most common cause of death from cancer in women.
Globally in 2012, it was estimated that there were 528,000 new
cases of cervical cancer, and 266,000 deaths.
About Sentinel Lymph Node Biopsy ApproachCancer patients
can frequently be cured of cancer by surgeries that remove their
tumors. To be successful, these surgeries must remove all of a
patient’s cancer. Residual tumor tissue in patients after surgery
can result in potentially life threatening disease recurrences. It
is very common that the first places to which a cancer may spread
(metastasize) beyond the primary tumor are to lymph nodes adjacent
to the tumor bed. During surgery in many types of cancer, the
current standard of care has been to remove at least 20 and as many
as 100 lymph nodes for examination for the presence of cancer.
However, wholesale lymph node removal frequently results in longer
and more painful recoveries and causes patients to develop
lymphedema, a serious post-surgical complication among other
morbidities and may also add dramatically to the cost and
complexity of surgeries.
These problems have led to growing acceptance of sentinel lymph
node biopsy (SLNB) as an alternative approach to full node
dissections. SLNs are those lymph nodes that are first encountered
by the lymphatic drainage away from a tumor. During an SLNB, only
the SLNs are removed and evaluated for the presence of cancer. When
SLNs do not contain cancer, which is very frequently the case,
there is no need to perform a lymphadenectomy, sparing patients of
the consequences of these procedures. In cancers such as cervical
cancer there remains a need for a safe and effective mapping agent
to reliably identify SLNs in all lymphatic drainage basins.
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 with breast cancer, melanoma and head and neck cancer
patients with oral cavity carcinoma. 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 lymphatic mapping to assist in the localization of
lymph nodes draining a primary tumor in patients with breast cancer
or melanoma and for use in guiding sentinel lymph node biopsy in
head and neck cancer patients with squamous cell carcinoma of the
oral cavity. The Company anticipates continuing development of
Lymphoseek into other solid tumor areas.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. According to publicly available information,
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 are
expected to be diagnosed in the United States in 2014, 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 (technetium Tc 99m tilmanocept) Injection
is indicated, using a hand-held gamma counter, for:
- Lymphatic mapping to assist in the
localization of lymph nodes draining a primary tumor site in
patients with breast cancer or melanoma;
- Guiding sentinel lymph node biopsy, in
patients with clinically node negative squamous cell carcinoma
(SCC) of the oral cavity.
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 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
developing multiple precision diagnostic products and platforms
including Manocept™, NAV4694, NAV5001, and NAV1800 (RIGScan™), to
help identify the sites and pathways of undetected disease and
enable better diagnostic accuracy, clinical decision-making 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. 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
statements.
Navidea BiopharmaceuticalsBrent Larson, Executive VP & CFO,
614-822-2330orSharon Correia, Associate Director, Corporate
Communications, 978-655-2686
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