Results
of Lymphoseek® Phase 3 Clinical Trials in Breast Cancer Published in Annals of
Surgical Oncology. Lymphoseek Meets Primary Efficacy Endpoint in Assessment of
Lymphatic Mapping Performance in Patients with Breast Cancer.
Full
press release follows.
SOURCE:
Navidea Biopharmaceuticals
DUBLIN,
Ohio--(BUSINESS WIRE)—(3-21-2013)
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on the development and commercialization of precision diagnostic
radiopharmaceuticals, today announced the peer-reviewed publication of results
from two Phase 3 clinical trials of Lymphoseek® (technetium 99m
tilmanocept) Injection in patients with breast cancer. The trials assessed the
performance of Lymphoseek against the standard of care, vital blue dye (VBD),
in lymphatic mapping. Results demonstrated that Lymphoseek met its primary
efficacy endpoint of rate of agreement, or concordance, with VBD. The study, “Comparative
Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast
Cancer Patients: Results of Two Phase 3 Trials,” was published in the current
online edition of the journal Annals of Surgical Oncology [DOI
10.1245/s10434-013-2887-8].
“These
data from breast cancer patients, in conjunction with previously published data
from our Phase 3 clinical trials in melanoma, comprise part of our NDA
registration package for Lymphoseek with the FDA. We are confident that
Lymphoseek may hold significant improvement for patients who undergo lymphatic
mapping procedures.”
Lymphoseek
is a receptor-targeted radiopharmaceutical recently approved by the U.S. Food
and Drug Administration and indicated for use in lymphatic mapping for breast
cancer and melanoma. In this procedure key lymph nodes adjacent to a primary
tumor, that may contain tumor metastases, are identified and biopsied to
determine if cancer has spread to these lymph nodes.
“Lymphoseek
was specifically designed to provide clinicians who perform lymphatic mapping
procedures with actionable information, and we believe that the data reported
in this publication demonstrate its utility and safety in identifying
tumor-draining lymph nodes,” said Frederick Cope, Ph.D., Senior Vice President,
Pharmaceutical Research and Clinical Development of Navidea. “These data from
breast cancer patients, in conjunction with previously published data from our
Phase 3 clinical trials in melanoma, comprise part of our NDA registration
package for Lymphoseek with the FDA. We are confident that Lymphoseek may hold
significant improvement for patients who undergo lymphatic mapping procedures.”
“Tilmanocept
was originally developed at UCSD as a targeted molecular approach to help stage
breast cancer and melanoma patients, and we advanced the agent through Phase 1
clinical trials with funding provided by Susan G. Komen Breast Cancer
Foundation and the American Cancer Society," said Anne Wallace, M.D.,
Chief, Division of Plastic Surgery; Professor of Surgery, UC San Diego School
of Medicine; Director of the Breast Care Unit; UC San Diego Moores Cancer
Center; and a Principal Investigator in the Lymphoseek Phase 3 clinical trials.
“The results from these Phase 3 clinical trials in breast cancer demonstrate
the potential that specifically-designed imaging agents may have an important
role in reliably localizing tumor-draining lymph nodes and in optimizing
patient management post-surgery. Appropriate lymphatic mapping and sentinel
node biopsy can benefit certain patients by sparing them removal of unnecessary
lymphoid tissue and preventing side effects such as lymphedema or swelling,
pain and sensory changes, scarring or disfigurement, and extended recovery
times.”
Completed
Lymphoseek Phase 3 Clinical Trials in Breast Cancer
Two
Phase 3 non-randomized trials were conducted in patients with breast cancer
undergoing lymphatic mapping. The primary endpoint was the rate of agreement
(concordance) between [99mTc]tilmanocept and vital blue dye, which
was defined as the proportion of lymph nodes identified by VBD that were also
identified by Lymphoseek. A pre-specified minimum rate of agreement of 90% had
been established in the trials’ statistical plan. In the trials, a total of 148
patients with breast cancer from 13 centers received [99mTc]tilmanocept
followed by vital blue dye and then underwent sentinel lymph node mapping.
Lymph nodes that demonstrated [99mTc]tilmanocept uptake and/or the
presence of blue dye were removed and examined for the presence of tumor. Of
the 209 blue-dyed lymph nodes removed from the patients, 207 (99.04%)
demonstrated [99mTc]tilmanocept uptake (p<0.0001).
In
assessing reverse concordance (the proportion of blue-dyed nodes relative to
all nodes with [99mTc]tilmanocept uptake) according to the protocol,
Lymphoseek detected 320 lymph nodes. Of these nodes, VBD detected 207 (64.69%).
Lymph
node identification
The
performance of [99mTc]tilmanocept in intraoperative lymph node
identification was also assessed. Of the patients injected with both [99mTc]tilmanocept
and vital blue dye who underwent surgical removal of the lymph nodes, 146
patients had at least one radioactive node, due to [99mTc]tilmanocept
uptake, and 131 patients had at least one blue node. This difference was
statistically significant (p<0.0001).
Pathology
Of 33
pathology-positive lymph nodes (18.2% patient pathology rate), [99mTc]tilmanocept
detected 31 of 33 positive lymph nodes found in the patients. Blue dye detected
25 of the 33 positive lymph nodes, but no positive lymph nodes were detected
exclusively by vital blue dye.
Safety
[99mTc]tilmanocept
was well tolerated in the trials, with no serious adverse reactions ascribed to
the radiopharmaceutical.
About
Lymphoseek®
Indication
and Important Safety Information About Lymphoseek
Indication
Lymphoseek
(technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping
with a hand-held gamma counter to assist in the localization of lymph nodes
draining a primary tumor site in patients with 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.
The most
common adverse reactions are injection site irritation and/or pain (<1%).
FULL
LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT: WWW.
LYMPHOSEEK.COM
Lymphoseek®
(technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted,
small-molecule radiopharmaceutical used in lymphatic mapping procedures that
are performed to help stage breast cancer and melanoma. Lymphoseek is designed
to identify the lymph nodes that drain from a primary tumor, which have the
highest probability of harboring cancer, in patients with breast cancer or melanoma.
Lymphoseek was approved for use by the U.S. Food and Drug Administration in
March, 2013.
Lymphatic
mapping is a procedure in which lymph nodes that may contain tumor metastases
are identified and biopsied to determine if cancer has spread beyond the
primary tumor. Accurate staging of cancer is critical, as it guides therapy
decisions and determines patient prognosis and risk of recurrence. According to
the American Cancer Society, approximately 232,000 new cases of breast cancer
and 77,000 new cases of melanoma are expected to be diagnosed in the United
States in 2013.1
About
Lymphatic Mapping
Lymphatic
mapping is a procedure designed to guide lymph node dissection and biopsy
procedures. It consists of Intraoperative Lymphatic Mapping (ILM) often accompanied
by lymphoscintigraphy. Lymphoscintigraphy is an imaging procedure routinely
performed pre-operatively to provide guidance on the location of lymph nodes to
be biopsied. ILM is a surgical procedure in which lymph nodes draining the area
around a tumor are identified and biopsied to determine if cancer has spread to
the lymph nodes. These nodes, medically referred to as “Sentinel Lymph Nodes,”
are removed and analyzed for the presence of malignant cells. Lymphatic Mapping
provides an accurate staging procedure that can help ensure optimal surgical
and therapeutic choices, including the avoidance of the morbidity of a complete
lymph node dissection for patients in whom the Sentinel Lymph Nodes were found
to be free of cancer.
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 actively developing four
radiopharmaceutical agent platforms – Lymphoseek®, NAV4694, NAV5001
and RIGScanTM – to help identify the sites and pathways of
undetected disease and enable better diagnostic accuracy, clinical
decision-making and, ultimately, patient care. 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.
1 Source:
ACS Cancer Facts & Figures, 2013
Contacts
Navidea
Biopharmaceuticals
Brent Larson, 614-822-2330,
Sr. VP & CFO
No comments:
Post a Comment