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IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Vice
President / CFO
614
822 2330
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May
28, 2009
Tim
Ryan,
The
Shoreham Group
646
342 6199
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NEOPROBE’S
SECOND PHASE 3 LYMPHOSEEK STUDY COMMENCES
Clinical
Study Evaluating Patients with Head and Neck Squamous Cell
Carcinoma
Conference
Call Scheduled to Discuss Trial
DUBLIN,
OHIO – May 28, 2009 -- Neoprobe Corporation (OTCBB: NEOP), a
diversified developer of innovative oncology surgical and diagnostic products,
today announced that a second multicenter Phase 3 study of Lymphoseek®
(NEO3-06) has received investigational review board approval to begin enrollment
of patients diagnosed with head and neck squamous cell carcinoma. The Phase 3
study will evaluate the efficacy of Lymphoseek to identify sentinel lymph nodes
that may be predictive of determining whether a patient’s cancer has spread into
the lymphatic system. The Phase 3 study has been registered on the national
clinical trials website www.clinicaltrials.gov.
David
Bupp, Neoprobe’s President and CEO, said, “Neoprobe is pleased to announce the
initiation of its second Phase 3 study for Lymphoseek. This Phase 3 study,
designated internally by Neoprobe as “Sentinel”, is designed to validate
Lymphoseek as a sentinel lymph node tracing agent. The trial will require the
accrual of sixty (60) patients with confirmed lymph node disease. The initiation
of the second Phase 3 study is a key milestone in the development of Lymphoseek
for Neoprobe and we expect the achievement of additional milestones in the
coming months.”
Fredrick
O. Cope, Ph.D., Neoprobe’s Vice President, Drug Development and Clinical
Research, said, “The Sentinel trial has the potential to favorably change the
treatment of patients with the devastating diagnosis of head and neck squamous
cell carcinoma. We are currently initiating clinical sites to enable them to
begin patient enrollment in the study. In the coming months, additional sites
will be initiated to commence patient enrollment including international
sites. We expect a total of approximately thirty sites to participate
in the trial.” Richard C. Orahood, M.D., Neoprobe’s Medical Director,
added, “The commencement of the Sentinel trial, coupled with confirmation from
the first Phase 3 study of Lymphoseek (NEO3-05) conducted in patients with
either breast cancer or melanoma, signifies an important milestone for Neoprobe.
The two Phase 3 studies are designed to support the new drug application (NDA)
and FDA registration of Lymphoseek.”
Neoprobe’s
President and CEO, David C. Bupp, and Vice President, Pharmaceutical Research
and Clinical Development, Frederick O Cope, Ph.D., will discuss the Sentinel
clinical study during a conference call scheduled for 11:00 AM EDT, June 1,
2009.
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Conference
Call Information
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TO
PARTICIPATE LIVE:
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TO
LISTEN TO A REPLAY:
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Date:
Time:
Toll-free
(U.S.) Dial in # :
International
Dial in # :
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June
1, 2009
11:00AM
ET
877-407-8033
201-689-8033
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Available
until:
Toll-free
(U.S.) Dial in # :
International
Dial in # :
Replay
pass codes (both required for playback):
Account
# :
Conference
ID # :
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June
8, 2009
877-660-6853
201-612-7415
286
324497
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NEOPROBE
CORPORATION
ADD
- - 2
About
Neoprobe
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
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-K
and other Securities and Exchange Commission filings. The Company
undertakes no obligation to publicly update or revise any forward-looking
statements.