NEOPROBE : Lymphoseek Data Presented at International Sentinel Node Society Annual Meeting
11/18/2010| 10:55am US/Eastern
Neoprobe Corporation (OTCBB: NEOP), a diversified developer of
innovative oncology surgical and diagnostic products, today announced
that investigators are presenting data and insights on Lymphoseek®
use in lymph node mapping and biopsy at the International Sentinel Node
Society (ISNS) Bi-Annual Meeting in Yokohama, Japan November 18-20, 2010
ISNS is the largest international meeting highlighting scientific
discovery and implementation of the latest technologies to improve and
advance lymphatic mapping to help improve patient diagnosis, treatment
and care. Lymphoseek presentations made at ISNS will highlight its value
in clinical oncology, including the utility of the agent in lymphatic
mapping in breast cancer and melanoma patients, review of the
development and successful performance of Lymphoseek in clinical trials
to date, and the outlook for potential development of next-generation
formulations of the compound.
?Lymphoseek presentations at ISNS 2010 signal an important step in the
international clinical community's interest in the technology's
potential to improve lymph node mapping and patient treatment and care,
and the growing importance of accurate intra-operative identification of
sentinel lymph nodes in surgical oncology,? said Dr. Frederick O. Cope,
Senior Vice President of Pharmaceutical Research and Clinical
Development of Neoprobe. ?We look forward to working with international
clinical leaders to advance the evidence of Lymphoseek's clinical
utility to help improve diagnosis in melanoma, breast, head and neck
cancer and other solid tumor cancers.?
Lymphoseek data and scientific presentations at ISNS 2010 included or
are scheduled to include:
?Development and Performance of [99mTc] Tilmanocept as a Sentinel
Lymph Node Mapping Agent,? Dr. A. Wallace, et al.
This session will be the first time a comprehensive overview of
Lymphoseek clinical data and drug development chronology have been
presented at a major medical meeting.
Dr. Wallace will review the results of all completed clinical trials of
Lymphoseek to date, including initial efficacy data in three Phase 1
studies in breast cancer and melanoma patients. Additionally, Dr.
Wallace's presentation will review the results of the multicenter Phase
2 and Phase 3 Lymphoseek clinical trials that demonstrated significantly
high concordance rates versus vital blue dye and rapid lymph node uptake
permitting earlier, typically immediate, lymphoscintigraphy imaging.
Lymphoscintigraphies are nuclear medicine imaging procedures intended to
preoperatively identify lymph nodes draining from a tumor site.
The NEO3-05 Phase 3 study was an open label trial of node-negative
subjects with either breast cancer or melanoma. It was designed to
evaluate the safety and the accuracy of Lymphoseek while identifying
lymph nodes draining from the subject's tumor site. To demonstrate the
accuracy of Lymphoseek, each subject consenting to participate in the
study was injected in proximity to the tumor with Lymphoseek and one of
the vital blue dyes that are commonly used in lymphatic mapping
procedures. The primary efficacy objective of the study was to identify
lymph nodes that contained the vital blue dye and to demonstrate a
statistically acceptable concordance rate between the identification of
lymph nodes with the vital blue dye and Lymphoseek. To be successful,
the study needed to achieve a statistical p-value of at least 0.05. The
protocol compliant clinical sites that participated in the NEO3-05 study
contributed 136 Intent-To-Treat (ITT) subjects who provided 215 lymph
nodes that contained the vital blue dye. 210 of the vital blue dye
positive lymph nodes contained Lymphoseek for an overall concordance
rate of 98%, achieving a highly significant statistical p-value of
0.0001. In addition to the nodes identified by vital blue dye and
Lymphoseek, Lymphoseek was able to identify 85 additional lymph nodes
that did not contain the vital blue dye, and 18% of these nodes were
found by pathology to contain cancer, pointing to the agent's ability to
identify lymph nodes containing occult tumors that can be missed by
conventional diagnostic methods.
The data further show that in all the Phase 1 through Phase 3 studies,
there were no significant safety events in any study related to
Lymphoseek. In all studies, Lymphoseek fulfilled its performance
objective relative to its prospective bio-targeting design toward
discerning lymphatic tissue in intra-operative lymphatic mapping.
?A Phase 2 Clinical Study of 99mTc-Lymphoseek in the Identification
of Sentinel Lymph Nodes in Melanoma and Breast Cancer,? Dr. R.C.
Orahood, et al.
Dr. Orahood will present findings from the previously announced Phase 2
study of Lymphoseek in lymphatic mapping procedures in 78 clinical
subjects with either breast cancer (31 subjects) or melanoma (47
subjects). The study evaluated the agent's efficacy in intra-operative
identification of lymph nodes draining primary breast cancer or melanoma
As previously reported, Lymphoseek identified ?hot spots? in 94.5% of
patients in nuclear medicine imaging studies prior to surgery.
Intra-operatively, Lymphoseek identified at least one regional lymph
node in 75/78 subjects (96.2%); 46/47 (97.9%) in melanoma and 29/31
(93.5%) in breast cancer, confirming its high level of performance in
this diverse set of cancers. Overall sensitivity by node was 92.0% with
a corresponding 8% false negative rate. Five serious adverse events
occurred; none were related to the investigational drug.
?A Receptor-Targeted Fluorescent Radiopharmaceutical for
Multi-Modality Sentinel Lymph Node Mapping at Multiple Spatial Scales,?
Dr. David Vera, et al.
Dr. Vera and colleagues will showcase pre-clinical results from initial
studies investigating a fluorescent formulation of Lymphoseek and the
potential utility of this formulation for use in lymph node mapping for
cancer diagnosis. The studies being presented at ISNS are intended to
demonstrate the feasibility of sentinel lymph node mapping with a
hand-held fluorescence detector and fluorescent imaging agent.
In addition, Lymphoseek is expected to be discussed at length in four
additional panel discussions at the ISNS conference.
?We are pleased to have Lymphoseek so prominently recognized at the ISNS
Bi-Annual Meeting,? said David Bupp, President and CEO of Neoprobe. ?The
presentation of this data underscores our belief in the merits of
Lymphoseek to significantly improve patient care in the treatment of
Neoprobe is a biomedical company focused on enhancing patient care and
improving patient outcome by meeting the critical intraoperative
diagnostic information needs of physicians and therapeutic treatment
needs of patients. Neoprobe currently markets the neoprobe®
GDS line of gamma detection systems that are widely used by cancer
surgeons. In addition, Neoprobe holds significant interests in the
development of related biomedical systems and radiopharmaceutical agents
including Lymphoseek® and RIGScan? CR. Neoprobe's
subsidiary, Cira Biosciences, Inc., is also advancing a patient-specific
cellular therapy technology platform called ACT. Neoprobe's strategy is
to deliver superior growth and shareholder return by maximizing its
strong position in gamma detection technologies and diversifying into
new, synergistic biomedical markets through continued investment and
selective acquisitions. www.neoprobe.com
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Brent Larson, 614-822-2330
President & CFO
Makovsky + Company
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