- Current report filing (8-K)
January 19 2010 - 6:03AM
Edgar (US Regulatory)
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):
January 18, 2010
AVI BioPharma, Inc.
(Exact name of registrant as specified in its charter)
Oregon
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001-14895
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93-0797222
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(State or other
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(Commission File
Number)
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(I.R.S. Employer
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jurisdiction of
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Identification
No.)
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incorporation)
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3450 Monte Villa Parkway, Suite 101
Bothell, WA 98021
(Address of principal executive offices)
(425) 354-5038
Registrants telephone number, including area code
(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:
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
7.01. Regulation FD Disclosure.
Item 8.01.
Other Events.
As previously announced, AVI
BioPharma, Inc. (AVI or the Company) entered into a contract with the
Transformational Medical Technologies Initiative (TMTI), a Department of
Defense program, to identify one or more RNA-based drug candidates against
pandemic H1N1 virus (also known as swine flu or swine origin influenza virus),
initially to the stage of preclinical testing. Under the agreement, AVI
conducted
in vitro
and
preclinical
in vivo
studies against
H1N1 to demonstrate the Companys ability to treat emerging infectious diseases
by producing multiple therapeutic candidates against H1N1 and preclinically
evaluating their efficacy. TMTI recently issued a press release regarding the
initial results from these studies. AVI is filing the following additional
statement in connection with the TMTI press release:
·
AVI generated
and tested several RNA-based drug candidates in a number of preclinical studies
using a mouse model of seasonal flu.
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The lead drug
candidate from the mouse studies has been advanced into ferret preclinical
testing utilizing a fully virulent human pandemic H1N1 virus.
·
The single ferret
study completed to date included various treatment groups employing different
doses of AVIs lead drug candidate, a scrambled sequence control, a saline
control and a positive control utilizing a standard of care drug, oseltamivir,
also known as Tamiflu.
·
AVIs lead
RNA-based candidate drug showed a statistically significantly greater reduction
in viral titer and clinical scores in infected ferrets than was seen with the
scrambled sequence control, the saline control or the positive control using
oseltamivir.
·
AVI intends to
repeat this study and obtain additional data, which may be available early this
year.
The information provided
under Items 7.01 and 8.01 in this Current Report on Form 8-K shall be
deemed to be filed for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the Exchange Act), and incorporated by reference
in any filing under the Securities Act of 1933, as amended, or the Exchange
Act.
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SIGNATURES
Pursuant to the
requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, as amended, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized, in the City of
Bothell, State of Washington, on January 19, 2010.
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AVI
BioPharma, Inc.
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By:
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/s/ Leslie Hudson,
Ph.D.
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Leslie Hudson, Ph.D.
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President
and Chief Executive Officer
(Principal Operating Officer)
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