AVI BioPharma Provides Update on New Business Plan: Increased Pipeline Focus, Skill Base and Strategy
June 10 2008 - 9:30AM
Marketwired
CORVALLIS, OR today provided an update on its actions to focus
its product development pipeline and to strengthen its emerging
position in directed alternative splicing. AVI's new business plan
was approved at a recent meeting of the Board of Directors and will
drive the Company's new focus going forward. The Company has
reduced its non-core work force in Corvallis and Portland, OR and
in Research Triangle Park, NC by relocation, selective re-hiring to
vacant positions and a reduction in force. Following analysis of
data from the initial phase of the adaptive design clinical trial
of AVI-5126 in CABG, the Company has decided to discontinue the
trial. The Company will continue the development of AVI-5126 in
cardiovascular restenosis with its partner, Cook Medical.
AVI's corporate priorities are to:
-- Advance the Company's clinical development programs in:
-- Duchenne muscular dystrophy
-- Ebola, Marburg, Junin and Dengue virus infections
-- Cardiovascular restenosis
-- Progress the soluble TNF alpha receptor 2 project -- which is based on
directed alternative splicing of the receptor's exon 7 -- through
Preclinical Development to Clinical Trial
-- Build synergy in its focused portfolio of Discovery Research targets
which direct RNA alternative splicing
-- Secure additional major partnerships, not only to validate the
portfolio of product candidates but also to demonstrate the wide
applicability of AVI's antisense chemistry to direct alternative
splicing of pre-mRNA therapeutic targets
Staff and skill base
AVI has reduced staffing levels and restructured to support the
Company's new focus in product development and discovery research.
Approximately 16% of AVI's staff -- those not directly involved in
the progression of the Company's priority projects -- were part of
a reduction in force. The Company believes that this reduction --
combined with the actions described above -- will save an estimated
$0.88 million in 2008 and an additional $1.6 million in 2009.
Cardiovascular Research
Following a futility analysis and data review, the Company
decided to discontinue its clinical trial to assess the safety and
efficacy of AVI-5126 in reducing clinically-significant graft
failure in coronary artery by-pass grafting (CABG).
AVI initiated this study in April 2007 as a randomized,
double-blind, placebo-controlled, multi-site adaptive design that
was intended to enroll up to a total of 600 patients undergoing
CABG. The goal of the study was to evaluate the safety and efficacy
of exposing a patient's saphenous vein to AVI-5126 prior to
grafting, compared to a placebo group treated with saline (1:1
randomization). The primary endpoint of the study was demonstration
of greater than or equal to 50% reduction in the clinical graft
failure rate (i.e., < 75% reduction in study vessel patency in
all study vessels of a patient) in the AVI-5126 group compared to
placebo at 1-year, based on angiography. An independent Data Safety
Management Board (DSMB) reviewed available safety and efficacy data
for each patient from the time of CABG until the end of study
surveillance at 1-year in an unblinded fashion. After the first 47
patients were treated and assessed, the DSMB reported a higher than
expected rate of graft failure based on 4-D CAT scans of coronary
arteries at 1-Month and 3-Months after CABG.
Complete data from 45 subjects were available for analysis.
Based on 4-D CAT scan results at Month 3, there were 13 patients
with at least one graft failure out of 23 patients exposed to
AVI-5126 and 7 patients with at least one graft failure out of 22
patients exposed to placebo (i.e., 57% failure rate for
experimental versus 32% in control group). Therefore, the
conditional power to meet the study's efficacy endpoint was only
66%. For 10 patients, angiograms were available at 1 year, and
those confirmed the occlusions that were found by 4-D CAT scans at
3 months. Both 4-D CAT scans and angiography showed the same rate
of re-occlusion in these patients. The probability of successfully
attaining the study's clinical endpoint, even at this early stage,
was deemed to be too low to warrant continuing the trial.
The analysis was not focused on clinical safety concerns since
there was no significant difference between the AVI-5126 or placebo
groups with respect to Major Cardiac Adverse Events (MACE). MACE is
conventionally defined to include: cardiac death, myocardial
infarction, emerging need for repeat CABG, stroke, major bleeding
complications and organ failure.
"These are significant steps in our commitment to focus AVI's
pipeline on our major product and R&D opportunities," said Dr.
Leslie Hudson, CEO of AVI BioPharma Inc. "The former includes our
significant success in the potential treatment of Ebola and Marburg
virus infections, which was highlighted in our opening presentation
at yesterday's symposium for the 6th Annual Biodefense Vaccines and
Therapeutics Meeting. For the latter, the current interest by large
pharmaceutical companies in RNAi has created an opportunity for
AVI. We believe that our antisense chemistry and the ability to
direct alternative splicing will position our Company to benefit
from this opportunity."
Analyst Call
The company has scheduled an analyst call for 9:00 a.m. EDT
(6:00 a.m. PDT) on Wednesday, June 11, 2008. The toll-free number
for the call is 866.507.1212.
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of
life-threatening diseases using third-generation NeuGene� antisense
drugs and alternative RNA splicing technology. AVI's alternative
RNA splicing technology is initially being applied to potential
treatments for Duchenne muscular dystrophy. AVI's NeuGene compounds
are also designed to treat cardiovascular restenosis. In addition
to targeting specific genes in the body, AVI's antiviral program
uses NeuGene antisense compounds to combat disease by targeting
single-stranded RNA viruses, including Marburg Musoke and Ebola
Zaire viruses. More information about AVI is available at
www.avibio.com.
"Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995: The statements that are not historical facts
contained in this release are forward-looking statements that
involve risks and uncertainties, including, but not limited to, the
results of research and development efforts, the results of
preclinical and clinical testing, the effect of regulation by the
FDA and other agencies, the impact of competitive products, product
development, commercialization and technological difficulties, and
other risks detailed in the company's Securities and Exchange
Commission filings.
AVI Press and Investor Contact: Michael Hubbard (Email Contact)
Director of Corporate Communications (503) 227-0554
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