|
IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson
Sr.
VP & CFO
(614)
822-2330
|
October
6, 2010
Gene
Marbach
Makovsky
+ Company
(212)
508-9645
|
NEOPROBE
COMPLETES LYMPHOSEEK PRE-NDA MEETING
–
FDA Requests Inclusion of NEO3-09 Data to Comply with Recently Established
Agency Guidelines –
–
Investor Conference Call Scheduled for October 7th at 9:00
AM ET –
DUBLIN,
OHIO – October 6, 2010 – Neoprobe Corporation (OTCBB: NEOP), a diversified
developer of innovative oncology surgical and diagnostic products, today
announced that it has completed a pre-NDA assessment for Lymphoseek® with the
U.S. Food and Drug Administration (FDA). As a result of the
pre-NDA assessment, FDA has 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.
The
previous plan to submit the NEO3-09 study data as a major amendment to the
ongoing NDA review for Lymphoseek was the outcome of the successful March 2,
2010 meeting with FDA. The pre-NDA meeting held earlier this week
with FDA was intended to review that plan for NDA submission with the safety and
efficacy data from the NEO3-05 study and a pre-planned major amendment to submit
the NEO3-09 study safety data as part of the ongoing NDA review.
NEO3-09
was originally intended as a supplement to the primary NDA for Lymphoseek for
safety evaluation purposes and to support expanded product labeling claims. The
pre-NDA assessment resulted in no modification to the NEO3-09 trial design or
endpoints or to any of the other previously agreed-to clinical or regulatory
components of the Lymphoseek NDA. As such, NEO3-09 will now be one of
two adequate and well-controlled trials included in the primary NDA submission
for first-cycle review.
NEO3-09
is currently enrolling patients at eight study sites across the
U.S. Neoprobe expects this study to be completed in the first quarter
of 2011 and to submit the primary NDA for Lymphoseek soon
thereafter.
David
Bupp, Neoprobe’s President and CEO, said, “Neoprobe has agreed to FDA’s request
to include safety and efficacy data for Lymphoseek from both clinical trials to
ensure that the Agency has the requested information to conduct a complete
first-cycle review of the NDA for Lymphoseek. We believe the earlier
than originally planned inclusion of the NEO3-09 study data will support
stronger product labeling as an outcome of a first-cycle review of the
Lymphoseek NDA and may also positively impact market adoption. The
clinical and regulatory team at Neoprobe is working diligently on this process
and looks forward to a complete and expeditious review of
Lymphoseek.”
Dr.
George Mills, consultant to the Company and former FDA Division Director of
Medical Imaging and Hematology Products, said, “The request for the total data
package from two clinical trials is consistent with FDA’s ongoing initiative to
push for more complete primary submissions and to limit major amendments made to
NDAs. This ongoing initiative to shorten drug review cycle times was
re-emphasized by FDA’s Office of New Drug Development in late 2009 and enables
more successful first-cycle reviews which ultimately shortens overall drug
approval timelines. The request for the inclusion of both clinical
trials in the primary NDA review should be viewed as a positive indicator for
Lymphoseek’s approval prospects in the first-cycle review by the
Agency.”
Neoprobe
will hold a conference call Thursday, October 7th at 9:00
AM ET to review the FDA request and provide an update following the pre-NDA
meeting. Mr. Bupp will be joined on the conference call by Dr. Frederick Cope,
Senior Vice President, Pharmaceutical Research and Clinical
Development. The conference call can be accessed as
follows:
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Conference
Call Information
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October
7, 2010
9:00
AM ET
(877)
407-8033
(201)
689-8033
|
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until:
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October
21, 2010
(877)
660-6853
(201)
612-7415
286
358364
|
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.