Attached files
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| 8-K - NAVIDEA BIOPHARMACEUTICALS, INC. | v205510_8k.htm |
Exhibit
99.1
 |
IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson
Sr.
VP & CFO
(614)
822-2330
|
December
14, 2010
Gene
Marbach
Makovsky
+ Company
(212)
508-9645
|
NEOPROBE
HOSTED ANALYST DAY IN NYC
–
Event Highlighted Head and Neck Cancer, Melanoma Science
–
–
Neoprobe Provided Analysts with Corporate, Drug Pipeline Updates
–
DUBLIN, Ohio – December 14, 2010 – At
its first Analyst Day, Neoprobe Corporation (OTCBB: NEOP), a diversified
developer of innovative oncology surgical and diagnostic products, provided
analysts and investors in attendance with an in-depth update on Neoprobe’s
corporate and drug pipeline developments as well insights into recent progress
in cancer diagnosis and treatment.
The event featured clinical and
scientific presentations on the challenges of treatment in head and neck cancer
and melanoma. The session also included a corporate update provided by Neoprobe
President and CEO David Bupp and a pipeline science review by Fredrick O. Cope,
Ph.D., Neoprobe Senior Vice President, Pharmaceutical Research and Clinical
Development. The New York City University Club gathering closed with a Q&A
session with analysts on improving cancer care through the development and
implementation of innovative technologies in the clinical
setting.
Cancer Diagnosis,
Treatment Highlighted by Clinical Thought Leaders
Dr. Amit Agrawal, Associate Professor in
the College of Medicine, Department of Otolaryngology—Head and Neck Surgery at
The Ohio State University Comprehensive Cancer Center, presented data and
clinical experiences in the treatment of head and neck cancers. Dr. Vernon
Sondak, Chief of the Division of Cutaneous Oncology at the H. Lee Moffitt Cancer
Center and Research Institute, provided an overview of melanoma and the medical
community’s experience diagnosing and treating the
disease.
In his presentation, Dr. Agrawal
presented learnings in the evolution of head and neck cancer treatment and
benefits including developing novel ways to diagnose and manage this disease.
“Although significant progress has been made in non-surgical treatment of head
and neck cancers, many cancers still require surgery to treat these cancers
successfully,” said Dr. Agrawal. “With this continued need for surgery, it’s
imperative that we develop less invasive technologies, like sentinel node
biopsy, to help physicians diagnose and treat cancerous tissue effectively with
the hope of avoiding more radical procedures and thereby limiting the damage to
healthy tissue in these patients.”
Dr. Sondak’s presentation on melanoma
provided analysts with a scientific overview of the disease, its surgical
diagnosis and targeting agents for treating it. In his review of melanoma
surgical diagnosis, Dr. Sondak commented on the critical role of sentinel lymph
node biopsy in predicting survival rates in these patients. “As we have seen in
multiple clinical studies, sentinel node biopsy is currently the most important
predictor of melanoma survival and is critical to helping physicians limit
disease recurrence in their patients,” said Dr. Sondak. “Melanoma patients
undergoing earlier sentinel node procedures experience less damage to their
lymph nodes, and more importantly, improved survival rates following diagnosis
and treatment.”
1
Neoprobe Technology
Overview, Pipeline Update Presented
Following the presentations by Drs.
Agrawal and Sondak, Dr. Frederick Cope presented a scientific overview of
Neoprobe’s GDS line of gamma detection systems, and its drug pipeline products
Lymphoseek® and RIGS. “The scientific presentations
by Drs. Agrawal and Sondak provided an outstanding look inside the science of
cancer diagnosis and treatment, and a better understanding of the value
Neoprobe’s technologies bring to treatment and patient care,” said Dr. Cope. “We
see the promise of our technologies – from our gamma detection devices to our
RIGScan technology – is in helping to address pressing clinical issues faced by
surgeons who seek to improve surgical procedures and care for those patients who
require surgical cancer treatment.”
Neprobe President and CEO David Bupp
also presented an update on the Company’s two pipeline programs,
Lymphoseek and RIGScan, highlighting the most
recent regulatory and clinical development milestones for these
products.
Lymphoseek, Neoprobe’s investigational
radioactive tracing agent for use with a gamma detection device in lymph node
mapping procedures, recently completed a pre-NDA meeting with the Food and Drug
Administration (FDA). In that meeting, FDA requested that data from both the
completed NEO3-05 study and the NEO3-09 study currently in progress be included
in the Company’s primary New Drug Application (NDA) for Lymphoseek rather than
submitting the NEO3-09 study data as a major amendment to the ongoing NDA
review. Neoprobe expects this study to be completed in the first quarter of 2011
and the Company plans to submit the primary NDA package for Lymphoseek shortly
thereafter.
Last week Neoprobe announced that FDA
has granted the Company a Type B pre-IND meeting to review its RIGS technology
Biologic License Application (BLA). “We see the RIGS technology as a potential
game-changer in the diagnosis of colorectal and other solid-tumor cancers that
have long been some of the most difficult to treat and deadly forms of cancer,”
said Dr. Mark Pykett, Neoprobe Executive Vice President and Chief Development
Officer, who is leading Neoprobe’s RIGS development initiative. “Our upcoming
pre-IND meeting with FDA is a key step in rapidly ramping up our development
efforts for our RIGS program in 2011. This meeting represents an opportunity for
further positive dialogue with FDA and serves as a tangible example of progress
in moving this product into the clinic and ultimately to
commercialization.”
In closing the session, Mr. Bupp
commented, “As we saw in the presentations at Analyst Day, surgeons continue to
face multiple challenges in the diagnosis and treatment of deadly cancers. It is
with these clinical challenges in mind that we at Neoprobe continue to work
aggressively to make progress on the regulatory and development milestones for
both Lymphoseek and RIGS, with the belief that these technologies will help
medical professionals better treat patients who look forward to healthy and
productive lives following their cancer treatment.”
For more detail on
Neoprobe’s disclosures from the event, including links to the presenters’
PowerPoint Presentations and audio replays, please visit http://www.neoprobe.com/AnalystDay.asp.
About Neoprobe
Corporation
Neoprobe Corporation (OTCBB: NEOP) 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™. 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.
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 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-KSB and other Securities and Exchange Commission filings. The
Company undertakes no obligation to publicly update or revise any
forward-looking statements.
###