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AVII - Sector: Healthcare --- Industry: Biotechnology & Drugs

Started by setravis, October 15, 2005, 02:11:17 PM

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stocks2watch2

October 21, 2005 09:00:07 (ET)


PORTLAND, Ore., Oct 21, 2005 (BUSINESS WIRE) -- AVI BioPharma, Inc. (AVII, Trade), today provided an update on its NEUGENE(R) antisense drug development program targeting the Influenza A (flu) virus. AVI has targeted genetic regions of the virus that are highly conserved between six viral subtypes that cause human disease. These include three subtypes that caused pandemics in the 20th century -- the 1918 Spanish flu (H1N1), the 1957 Asian flu (H2N2) and the 1968 Hong Kong flu (H3N2) -- and three subtypes of avian flu that have been reported to cause disease in man (H5N1, H7N7 and H9N2).

"Several of these NEUGENE compounds have been efficacious in early experiments and should now be considered for in vivo evaluation against H1N1 and H5N1," said Denis R. Burger, Ph.D., chief executive officer of AVI. "AVI has a successful track record of developing antisense drug candidates against RNA viruses quickly -- what we refer to as our rapid response therapeutic platform. Our antiviral program has shown that we can potentially develop a NEUGENE antisense drug candidate for avian flu in a relatively short time frame, as we did for West Nile virus, SARS coronavirus and Ebola virus."

In initial experiments, eight NEUGENE antisense compounds were developed to target regions of the influenza virus genome believed to be critical to virus survival. AVI also selected regions of the virus that are highly conserved across all six virus subtypes that cause human disease. These candidates have been tested in various viral culture assays with several collaborators, including Professor J. Chen and Quing Ge at the Massachusetts Institute of Technology. Several agents that were both potent and specific for Influenza A have been identified as suppressing replication of H1N1. One agent was found to inhibit both viral transcription and replication. Moreover, combinations of two agents were routinely twofold to threefold more active than single agents alone, and one combination of two agents exhibited sevenfold to eightfold improvement in viral reduction compared with a single agent.

Additional experiments showed that a single mismatch within the targeted region of the virus caused less than a 10 percent loss of activity of the drug. This provides strong evidence that a single NEUGENE antisense drug could potentially shut down all the flu virus subtypes, including the H5N1 avian flu, even if a mutation occurred in these highly conserved regions.

AVI's Antiviral Program

AVI's proprietary NEUGENE antisense drug candidates have demonstrated efficacy in preclinical studies against SARS coronavirus, West Nile virus (WNV), hepatitis C virus (HCV), dengue virus, Ebola virus, and Marburg virus. AVI has filed Investigational New Drug (IND) applications with the U.S. Food and Drug Administration and has ongoing clinical trials in WNV and HCV. Additional clinical development efforts targeting dengue virus and Ebola virus are planned for 2006. Compounds targeting SARS, WNV and Ebola virus were developed within days to weeks of obtaining appropriate genetic sequences. AVI has demonstrated that NEUGENE agents were efficacious against all four immunologically distinct subtypes of dengue virus. This was achieved by targeting a highly conserved region of the dengue gene. In collaborative work targeting the Ebola virus, NEUGENE drugs protected three animal species from lethal challenges with this virus.

"Studies that have shown efficacy across the four dengue viral strains demonstrate that NEUGENE antisense agents can target conserved regions of the viral genome even when the strains are immunologically separated, as appears to be the case with influenza," said Patrick L. Iversen, Ph.D., senior vice president of research and development for AVI. "We now have experience with translating effective compounds in cell culture into efficacy in viral challenge studies in animal models including coronaviruses, dengue virus and Ebola virus. This indicates that we are up to the challenge of targeting avian flu."

AVI's Clinical Experience

AVI's NEUGENE antisense platform has a well-defined safety record in human clinical trials. Approximately 250 patients have been dosed with NEUGENE drug candidates targeting host and viral gene targets in 11 clinical studies under multiple INDs. Five different routes of administration have been employed in AVI's clinical studies, and doses up to 450 mg have been administered without a single drug-related, serious adverse event. The combination of AVI's NEUGENE chemistry with conserved viral targets that are not expressed in the human genome makes a strong case for the potential for success in the development of candidates to address the possible emergence of a transmittable avian flu.


setravis

AP
AVI Thinks Antisense Drugs Can Beat Flu
Friday October 21, 12:23 pm ET 
AVI BioPharma Believes Antisense Drugs Can Shut Down Replication of Flu Viruses


PORTLAND, Ore. (AP) -- AVI BioPharma Inc. said Friday that certain combinations of its antisense drugs in lab experiments have reduced genetic replication several-fold in the virus that caused the 1918 Spanish flu pandemic that killed up to 40 million people worldwide.
The company said scientists trying several combinations of Neugene antisense drug compounds have reduced viral activity of the H1N1 virus from two- to eight-fold compared to a single agent, leading the company to believe that the compounds, or even a single compound, could be effective in shutting down different flu viruses.

The company is studying the use of antisense drugs in six types of flu virus, three of which are viruses known to cause avian flu in humans.

Antisense drugs are a class of compounds that interfere with genetic material that gets translated into harmful proteins.

AVI BioPharma shares rose 5 cents to $3.21 in midday trading on the Nasdaq.



"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

bizjournals.com
AVI Biopharma reports flu progress
Friday October 21, 1:07 pm ET


AVI Biopharma Inc. announced today new developments in its Neugene antisense drug program aimed at finding therapies for the influenza A virus.
The company is focused on six subtypes of the flu, including three that caused pandemics in the 20th century and three subtypes of avian flu that have been reported to cause disease in humans.

AVI (NASDAQ: AVII - News) is a Portland-based drug development company

Published October 21, 2005 by The Business Journal


"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Positive update on drug development.

Support @ $3.01...2.88...2.75...2.57
Resistance @ $3.36
MACD is bullish
Stochastic is neutral

Technicals
Last Price Quote is:
8.48%above 13-day EMA
26.02%above 50-day EMA
RS Rating: 96 
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

caressofsteel

Dont forget to tell the newbiew that this company is also involved with stemcells.  That is was brought about the last huge spike in the companies trade chart. (march area - i think)
ssupposedlythere neugene products extend the amt of time that stemcells can be used being transported from a to point b.  Don't know many details on that piece of news but it is out there for anyone willing to do their DD.  Worthwhile read

David Randolph

We've had this news on Friday:

AVI BioPharma Provides Update on Influenza Drug Development Program; NEUGENE Antisense Agents Target Conserved Regions of All Significant Influenza Subtypes, Including Avian Influenza

It's strange this news didn't provide more upside to AVII, possibly the stock wasn't ready in technical terms. Reading the news it is clear that AVII is a valid avian flu play.

I want to keep on holding this stock for as long as the market agrees this is a valid play, and I measure that in an objective way by a comparison between the stock's closing price and the ascending trendline on the chart below.

Therefore, my trading plan on AVII is to hold the stock for as long as it is set to close above the ascending trendline, which for tomorrow will be standing at $2.95.

puenthouse

Following my plan of taking profits and running.  Thanks again 422.  This jump gave me a 18% profit.  this puppy will raise or fall after this 12% raise (of course), must have had another bird flu special on cnn :D.   but im still in the rebuiliding stage so when i see green i must take what i can when i can.   GL   sold at 3.76
Learning from every trade.

422fwhp

Although it's never wrong to sell for a profit you can miss out on bigger gains many times.

I sold NVAX at the end of the day on Friday with a nice 22% gain in 2 days and today at ran up over +30%.   Hind sight is 20/20...haha, I just quoted my dad.  Scary.

Congrats on your profit.

Jody

setravis

Bingo!!! There's the move. ;D

Support @ $3.49...3.20...2.88...2.75
MACD is bullish
Stochastic is bullish

Technicals
Percentage Gainer

Last Price Quote is:
32.68%above 13-day EMA
54.29%above 50-day EMA
RS Rating: 98 

Fundamentals
Key Data:
Market Cap (M): $144.04 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 11/10/2005
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Press Release Source: AVI BioPharma, Inc.


Results From AVI BioPharma's Antiviral Program Published in Two Virology Journals
Tuesday October 25, 9:00 am ET


PORTLAND, Ore.--(BUSINESS WIRE)--Oct. 25, 2005--AVI BioPharma, Inc. (Nasdaq: AVII - News), today announced publication of preclinical research in the Journal of Virology and the Journal of General Virology. The results detail findings from studies of AVI's NEUGENE® antisense agents in cell models of dengue virus and equine arteritis virus.


"We continue to see robust preclinical data further validating the antiviral applications for our NEUGENE antisense compounds," said Denis R. Burger, Ph.D., chief executive officer of AVI. "Our dengue virus program has generated substantial results thus far, and we are moving toward the initiation of human clinical trials, which are expected to begin next year. Dengue virus is an emerging global health problem and another RNA virus well-suited to our rapid response therapeutic approach."

The first publication, in the November edition of the Journal of Virology (http://jvi.asm.org), is titled "Inhibition of dengue virus translation and RNA synthesis by a morpholino oligomer targeted to the top of the terminal 3' stem-loop structure." AVI's NEUGENE antisense agent inhibited each of the four serotypes of dengue virus. This is an important finding, as each of the four dengue serotypes can lead to separate infection.

Dengue virus is the subject of one of five AVI programs recently allocated preliminary funding from the U.S. Senate Committee on Appropriations as part of the fiscal year 2006 defense spending bill. The other four antiviral programs funded involve development of drugs to treat Ebola and Marburg viruses, and anthrax and ricin toxins.

Appearing in the November edition of the Journal of General Virology, pages 3081-3090, is a publication titled "Antiviral activity of morpholino oligomers designed to block various aspects of equine arteritis virus amplification in cell culture." This research demonstrated that virus replication could be completely inhibited by NEUGENE concentrations in the low micromolar range. An abstract of the publication is available online at http://vir.sgmjournals.org.

About Dengue Virus

Dengue fever/dengue hemorrhagic fever (DF/DHF) is an emerging complex of clinical syndromes caused by dengue viruses. DF/DHF has become a major global health problem over the past 20 years. The World Health Organization estimates that over 50 million human infections occur each year. DF/DHF has become the leading cause of hospitalization and death among children in Southeast Asia, and the incidence of infection and disease are sharply rising in the Americas as well. There is currently no commercially available vaccine or effective therapy. Medical supportive care is the recommended primary treatment to improve the condition of severely infected patients.

About AVI BioPharma

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. 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 West Nile virus, hepatitis C virus, dengue virus and Ebola virus. AVI has introduced a NEUGENE-based exon-skipping technology called ESPRIT therapy. More information about AVI is available on the company's Web site at http://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.



--------------------------------------------------------------------------------
Contact:
     AVI Contact:
     AVI BioPharma, Inc.
     Michael Hubbard, 503-227-0554
     [email protected]
     or
     Investor Contacts:
     Lippert/Heilshorn & Associates Inc.
     Bruce Voss, 310-691-7100
     [email protected]
     or
     Jody Cain, 310-691-7100
     [email protected]
     or
     Press Contact:
     Waggener Edstrom Bioscience
     Wendy Carhart, 503-443-7000
     [email protected]



--------------------------------------------------------------------------------
Source: AVI BioPharma, Inc.


"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

irod

Isn't that always the problem?

Two of the most quoted rules of investing:

- Don't let your profits turn into a loss.
- Let your profits run.

They're almost contradictory without knowing the future! That's the hardest thing about trading for me, knowing when to follow which.

setravis

9:08AM AVI BioPharma announces publication of preclinical research (AVII) 3.23 :Co announced publication of preclinical research in the Journal of Virology and the Journal of General Virology. The results detail findings from studies of AVII's Neugene antisense agents in cell models of dengue virus and equine arteritis virus. "Our dengue virus program has generated substantial results thus far, and we are moving toward the initiation of human clinical trials, which are expected to begin next year." Also, research in the November edition of the Journal of General Virology, titled "Antiviral activity of morpholino oligomers designed to block various aspects of equine arteritis virus amplification in cell culture," demonstrated that virus replication could be completely inhibited by Neugene concentrations in the low micromolar range.

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Bingo David!!! The move is on. Let's rock!
I'm with you on this one also.
I also have a thread running on this.

http://www.3stocksonfire.org/trading/index.php?topic=3160.0
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

David Randolph

AVII is clearly a Bird Flu play. But it comes in third place after NVAX and HEB.

Volume on AVII wasn't so great, because it was lower than the volume on the previous high. Anyway I think this is a valid holding, one that will see it's share price advance. Perhaps not so fast and with not so much vigour, but advancing still.

Speculation around the Bird Flu small cap group seems to be just starting, I'll let the profits run on AVII.

la-onda

AVI BioPharma Announces 2005 Third Quarter Financial Results Conference Call
Thursday October 27, 4:00 am ET

PORTLAND, Ore.--(BUSINESS WIRE)--Oct. 27, 2005--AVI BioPharma Inc. (Nasdaq: AVII - News) today announced that the Company will hold a conference call to discuss 2005 third quarter financial results on Friday, November 4, 2005, at 11:00 a.m. Eastern Time (8:00 a.m. Pacific Time).

Individuals interested in listening to the live conference call may do so by dialing (888) 803-8271 toll free within the U.S. and Canada, or (706) 634-2467 for international callers. A telephone replay of the conference call will be available for 48 hours beginning November 4 within two hours after the conclusion of the call, by dialing (800) 642-1687 domestically, or (706) 645-9291 internationally and entering reservation number 1566153.

The conference call can be heard live via audio webcast at the Company's Web site: www.avibio.com. A replay will also be available for 14 days.