Attached files
| file | filename |
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| EX-99.1 - NAVIDEA BIOPHARMACEUTICALS, INC. | v211381_ex99-1.htm |
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
|
Date
of Report (Date of earliest event reported)
|
February 14,
2011
|
NEOPROBE CORPORATION
(Exact
name of registrant as specified in its charter)
|
Delaware
|
0-26520
|
31-1080091
|
|
(State
or other jurisdiction
|
(Commission
|
(IRS
Employer
|
|
of
incorporation)
|
File
Number)
|
Identification
No.)
|
|
425 Metro Place North, Suite 300, Columbus,
Ohio
|
43017
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
|
Registrant's
telephone number, including area code
|
(614)
793-7500
|
(Former name or former address, if changed since last report.)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
o Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
8.01. Other Events.
On February 14, 2011, Neoprobe
Corporation (the “Company”) issued a press release announcing that a
multi-center Phase 3 study of Lymphoseek® has enrolled clinical subjects to
achieve the minimum analysis goal of 196 lymph nodes, the study’s primary
accrual objective. The multi-center open label study was conducted in subjects
with either breast cancer or melanoma in accordance with the clinical protocol
registered on www.clinicaltrials.gov (NCT01106040). An earlier Phase
3 multi-center study (NEO3-05) of Lymphoseek® was conducted in subjects with
breast cancer or melanoma. In the NEO3-05 study an overall localization rate of
over 97% in lymph nodes was achieved in those patients where both a vital blue
dye and Lymphoseek were used. A similar concordance rate was established by the
Company and the United States Food and Drug Administration as the primary
efficacy objective for the NEO3-09 Phase 3 clinical study. No incidents related
to drug safety have been reported in the Lymphoseek studies. A copy
of the complete text of the Company’s February 14, 2011, press release is
attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
Statements contained or incorporated by
reference in this Current Report on Form 8-K 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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
|
Exhibit
Number
|
Exhibit Description |
|
99.1
|
Neoprobe
Corporation press release dated February 14, 2011, entitled “Neoprobe's
Phase 3 Lymphoseek Study Reaches Accrual
Goal.”
|
2
SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly
authorized.
|
Neoprobe
Corporation
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|||
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Date:
February 14, 2011
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By:
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/s/ Brent L.
Larson
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|
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Brent
L. Larson, Senior Vice President and
Chief
Financial Officer
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