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

[setravis]

Huge potential super high flier for speculation. Ebola, Ricin, Avian flu drugs!
This stock could be a moon rocket based on speculation alone.
Support @ $2.90...2.79...2.58
Macd is Bullish........RSI moving through 70

Technicals
Gap Up
Percentage Gainer

Last Price Quote is:
24.29%above 13-day EMA
37.75%above 50-day EMA
RS Rating: 96  

[setravis]

Profile Get Profile for: 


AVI Biopharma Inc.
One SW Columbia Street
Suite 1105
Portland, OR 97258
Phone: 503-227-0554
Fax: 503-227-0751
Web Site: http://www.antivirals.com

DETAILS   
Index Membership: N/A
Sector: Healthcare
Industry: Drug Manufacturers - Other
Full Time Employees: 112


BUSINESS SUMMARY   
AVI BioPharma, Inc. engages in the development and commercialization of therapeutic products based on NEUGENE antisense and cancer immunotherapy technology. Its principal products in development target cardiovascular restenosis, infectious disease, cancer, polycystic kidney disease, and drug metabolism. The company's antiviral program uses NEUGENE antisense compounds to target single-stranded RNA viruses, including West Nile virus, SARS coronavirus, calicivirus, and hepatitis C. AVI BioPharma's second technology, AVICINE, is a therapeutic cancer vaccine. The company completed six human clinical trials for AVICINE, including multicenter phase II trials for colorectal cancer and pancreatic cancer. The company has strategic alliances with Exelixis, Inc.; DepoMed, Inc.; XTL Biopharmaceuticals, Ltd.; SuperGen, Inc.; and Abgenix, Inc. AVI BioPharma was incorporated in Oregon in 1980 and its principal executive offices are located in Portland, Oregon.

[setravis]

AP
AVI Releases Good Neugene Animal Data
Friday October 14, 10:57 am ET 
AVI BioPharma Releases Neugene Data Showing Resistance Against Lethal Toxins in Animals


PORTLAND, Ore. (AP) -- AVI BioPharma Inc. said Friday that its antisense drugs showed positive results against four lethal agents in preclinical studies conducted with Army researchers.
Shares of AVI BioPharma Inc. rose 40 cents, or 14.8 percent, to $3.10 on the Nasdaq. Company shares have traded over the past 52 weeks in a range of $1.98 to $4.24.


In four separate programs with the Army's Medical Research Institute of Infectious Diseases at Fort Detrick, Md., AVI found that combinations of its Neugene antisense technology combatted the Ebola and Marburg viruses and the potential bioterror weapons of anthrax and ricin in animal tests. The company said that it is also studying how antisense drugs can combat the avian flu H5N1.

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

Results showed that the most effective drug combinations produced 100 percent survival rates against Ebola genes in mice and guinea pigs one to two days after they had been infected.

In another guinea pig study, the Neugene drugs produced a "high survival rate" in animals infected with the Marburg virus, which killed all untreated animals.

Almost all mice infected with anthrax and treated with antisense drugs survived, the company said. Also, in cell culture studies, researchers found that 75 percent of cells remained viable after a 100 percent lethal dose of ricin, an enzymatic toxin made from caster beans.

[setravis]

MarketWatch
Market Pulse: AVI BioPharma shares soar on Neugene study results
Friday October 14, 11:54 am ET
By Carolyn Pritchard


SAN FRANCISCO (MarketWatch) -- AVI BioPharma Inc. shares rose as much as 20% to trade at $3.25 early Friday after the company released positive study results for its Neugene antisense agents. The animal studies, which were partially funded by Department of Defense, found that Neugene agents were successful in combatting both the Ebola and Marburg viruses. They were also found to interrupt the cellular mechanism that ricin and anthrax toxins employ to induce lethal toxicity. Portland, Ore.-based AVI also said it's using its technology to address the avian flu H5N1.

[setravis]

Press Release Source: AVI BioPharma, Inc.


CORRECTING and REPLACING AVI BioPharma Updates Results from Department of Defense Funded Collaborative Programs
Friday October 14, 1:12 pm ET 
NEUGENE Antisense Agents Effective at Combating Ebola and Marburg Viruses and Ricin and Anthrax Toxins


PORTLAND, Ore.--(BUSINESS WIRE)--Oct. 14, 2005--In BW5198 issued Oct. 14, 2005: Tenth graph, second sentence, should read: The anthrax lethal toxin (LT) activates host proteins (sted: The anthrax lethal toxin (LT) activates cellular phosphatases)

The corrected release reads:

AVI BIOPHARMA UPDATES RESULTS FROM DEPARTMENT OF DEFENSE FUNDED COLLABORATIVE PROGRAMS; NEUGENE ANTISENSE AGENTS EFFECTIVE AT COMBATING EBOLA AND MARBURG VIRUSES AND RICIN AND ANTHRAX TOXINS

AVI BioPharma, Inc. (Nasdaq:AVII - News) today announced results from four programs partially funded by The United States Department of Defense (DoD) and in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Md. AVI has successfully used its NEUGENE® antisense technology to combat the Ebola and Marburg viruses and to interrupt the cellular mechanism that ricin and anthrax toxins employ to induce lethal toxicity.

Ebola and Marburg Virus Results

Ebola virus studies in three animal species have been conducted at USAMRIID. The studies provided evidence of robust efficacy in multiple experiments conducted on mice, guinea pigs and nonhuman primates. Previous attempts by USAMRIID to treat Ebola virus with other technologies have demonstrated few successes in treating all three species.

Using Ebola virus mouse and guinea pig models, AVI targeted six of the seven Ebola virus genes with multiple compounds. The compounds were used as single agents and in combinations in prophylactic and therapeutic models. Among these studies, the most effective protocols, where 100 percent survival was observed at low doses of drug, were three-drug combinations targeting different Ebola genes when administered 24-48 hours after virus challenge.

Several of the antisense compounds that were efficacious in the mouse studies were also studied in the guinea pig model as single agents and in combinations. The guinea pig model was employed because it is a more rigorous model for Ebola virus efficacy. Results were similar to what was observed in the mouse studies with therapeutic protocols using combination agents being most effective.

Based on the mouse and guinea pig experience, a three-drug combination was used in initial nonhuman primate studies and also was successful. Consistent with previous preclinical and clinical studies in other disease settings, AVI's NEUGENE compounds were well-tolerated, from a safety perspective, by the NEUGENE-treated nonhuman primates.

In experiments designed to evaluate NEUGENE antisense agents targeting the Marburg virus, the guinea pig animal model was used, and the experimental design was similar to the studies on Ebola virus. More than 20 antisense compounds directed against multiple Marburg genes as single agents have been tested first in vitro, as well as in both prophylactic and therapeutic regimens in a guinea pig model of Marburg virus.

In animals challenged with high doses of the virus that were nearly 100 percent lethal in untreated animals, a high survival rate was observed in single agent protocols targeting distinct Marburg genes. The antisense agents were virus-specific; antisense treatment targeting Ebola virus did not protect animals against Marburg virus. Combination therapeutic studies, such as those that provided the most potent efficacy against Ebola virus, are currently underway for Marburg virus in guinea pigs.

Ricin Toxin Results

Ricin is an enzymatic toxin from the caster bean. It is composed of two peptides, one responsible for cell entry and the other for toxicity. Once inside the cell, the ricin enzyme cuts ribosomal RNA at the crucial initiation site. Without a functional initiation site, the cell cannot produce proteins, and cell death is rapid.

AVI's approach was to use NEUGENE antisense agents designed to block the ricin target site on ribosomal RNA, and therefore interfere with ricin enzymatic activity. Experiments conducted in cell-free systems indicated that ricin activity was inhibited with antisense blocking of the initiation site. In cell culture studies, where ricin was 100 percent lethal, greater than 75 percent cellular viability was achieved with antisense targeting the ricin binding site on ribosomal RNA. These preliminary results indicated that the approach was feasible and proof of principle has been established.

Anthrax Results

Anthrax is caused by toxins produced after infection with Bacillus anthracis. The anthrax lethal toxin (LT) activates host proteins that go on to trigger the apoptotic or cell-death pathway in cells that are infected. The approach that AVI and USAMRIID have taken to counter this cycle was to target host proteins that the anthrax toxin uses. In this manner, if the infected cells are inhibited from expressing the anthrax target, then apoptosis will not be induced and cell death will be reduced or prevented.

Experiments conducted in cell culture indicated that antisense targeting the relevant genes significantly down-regulated its expression, which led to increased cell survival without extensive apoptosis. Preliminary survival experiments in mice showed that almost all antisense-treated mice survived a lethal challenge with anthrax spores. Together, these experiments indicate proof of principal of the approach, and more robust experimentation is planned.

AVI's Partnership with USAMRIID

USAMRIID is the only laboratory in the DoD and one of only a few laboratories in the United States equipped to safely study highly hazardous infectious agents such as Ebola virus. Ebola virus often causes hemorrhagic fever, which historically has killed up to 80 percent of infected humans. As such, Ebola virus requires the maximum biocontainment and security, biosafety level 4 (BSL-4).

"Protecting the military and citizens from a possible bioterror threat remains an urgent and highly critical mission," said Sina Bavari, Ph.D. chief of immunology, target identification, and translational research, USAMRIID. "The results announced today not only represent important progress for the potential treatment of these deadly biothreats, but also evidence of the DoD's ability to rapidly and successfully partner with private industry to enhance our nation's biodefense efforts."

"We believe AVI's technology, which has demonstrated an excellent pharmacokinetic and safety profile in humans, may be directed against a broad range of potential biodefense threats, and we are encouraged by the results we have seen to date," said Denis R. Burger, Ph.D., chief executive officer of AVI. "Our work with the DoD allows us to develop drugs that have an important public health impact, and we are now applying our technology to address the potential emergence of avian influenza H5N1."

About Ebola Zaire and Marburg Viruses

Ebola hemorrhagic fever is a severe, often-fatal disease in humans and nonhuman primates (monkeys, gorillas and chimpanzees) that has appeared sporadically since its initial recognition in 1976. The disease is caused by infection with Ebola virus, named after a river in the Democratic Republic of the Congo (formerly Zaire) in Africa, where it was first recognized. Ebola virus and Marburg virus are the only two members of a family of RNA viruses called the Filoviridae.

Researchers have hypothesized that the first patient becomes infected through contact with an infected animal. After the first case-patient in an outbreak setting is infected, the virus can be transmitted in several ways. People can be exposed to Ebola virus from direct contact with the blood and/or secretions of an infected person.

The disease is a National Institute of Allergy and Infectious Disease (NIAID) priority A pathogen and a bioterrorism suspect agent of interest to the Department of Defense and Project BioShield. There are currently no approved treatments for Ebola.

Marburg virus was first recognized in 1967, when outbreaks of hemorrhagic fever occurred simultaneously in laboratories in Marburg and Frankfurt, Germany, and in what is now Serbia. Marburg hemorrhagic fever is a rare, severe type of hemorrhagic fever that affects both humans and nonhuman primates. Caused by a genetically unique animal-borne RNA virus, its recognition led to the creation of this virus family.

The most recent outbreak of Marburg virus started in October 2004 in Angola. According to the World Health Organization (WHO), as of Aug. 23, 2005, the Ministry of Health (MOH) of Angola had reported a total of 374 cases of Marburg hemorrhagic fever with 329 fatalities. The toll far exceeds the previous worst outbreak recorded in Angola's neighbor country, the Democratic Republic of Congo, in 1998, when 123 people died.

About Ricin Toxin

Ricin, a plant toxin from the seeds of the castor bean, is one of the most poisonous naturally occurring substances known and is poisonous to people, animals and insects.

Ricin inhibits protein synthesis by specifically and irreversibly inactivating ribosomes. These ribosome-inactivating proteins are typically monomers. However, to bind to the cell surface and enter the cell to reach the ribosomes, ricin requires a second monomer. Ricin, therefore, is a heterodimeric protein where the ribosome-inactivating enzyme, known as the A chain, is linked to the cell surface binding peptide, called the B chain. The ricin A chain of the heterodimer is the enzyme that binds and inactivates ribosomal RNA. Just a single ricin molecule that enters the cell can inactivate over 1,500 ribosomes per minute and kill the cell.

About Anthrax

Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Bacillus anthracis is an encapsulated gram-positive, nonmotile, aerobic, spore-forming bacterial rod. Anthrax is most common in agricultural regions where it occurs in animals. When anthrax affects humans, it is usually due to an occupational exposure to infected animals or their products.

Three virulence factors account for majority of the clinical manifestations of Bacillus anthracis and are edema toxin, lethal toxin and an antiphagocytic capsular antigen. The lethal toxin is the most important in pathogenesis and primarily responsible for the primary clinical manifestations of hemorrhage, edema and necrosis.

In terms of bioterrorism, inhalation anthrax is the greatest concern. Case-fatality rates for inhalation anthrax are high, even with appropriate antibiotics and supportive care. Among the 18 cases of inhalation anthrax in the United States during the 20th century, the overall case fatality was greater than 75 percent. Following the bioterrorist attack in fall 2001, the case-fatality rate among patients with inhalation disease (all of whom received antibiotic therapy) was 45 percent (5/11).

About USAMRIID

USAMRIID, located at Fort Detrick, Md., is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, therapeutics and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.

The information contained in this press release does not necessarily reflect the position or the policy of the Government, and no official endorsement should be inferred.

[David Randolph]

I don't have the time to dig a lot inside this company's information, so I'll write what it comes up on a first glance analysis (after all, we should take the same time to buy a stock than to buy a a new refrigerator, and I don't take more than 5 or 10 minutes buying that  )

- In January institutions bought 8 million shares at $3, giving the company $24M in funding.
- The company has a collaborative program withe the Department of Defense
- They never said they're developing a Bird Flu vaccine, but the market is pretty much assure that they are (it is a good thing the company is not talking loud about this)
- Yesterday they had some positive news on their tests on the Ebola virus and anthrax:

AVI BioPharma Updates Results from Department of Defense Funded Collaborative Programs; NEUGENE Antisense Agents Effective at Combating Ebola and Marburg Viruses and Ricin and Anthrax Toxins

I went on looking and reading news from the past, and found this:

«"We've not put out anything public on that, but it's right up our alley," said Michael Hubbard, the company's investor relations director. "It would be a logical assumption that we would look at anything that's in our theater."»

Well, I guess «solid» is too much of an adjective for this company, what I meant by «solid» was that it has businesses outside of the Bird Flu speculation, and those businesses are supported by the Department of Defense.

I will buy AVII for the 3 Stocks on Fire Portfolio at today's open.

[setravis]

Active in the pre-market
+ 10.45%.....Volume @ 186,810

[LiveLife]

Another nice pick David!

I am holding NVAX, so I am transferring more money into Scottrade account to buy AVII.

Keep up the good work! 

[David Randolph]

Another nice pick David!

I am holding NVAX, so I am transferring more money into Scottrade account to buy AVII.

Keep up the good work! 

Thanks LiveLife 

AVII opened too high, then the stock came down to close the opening gap and recovered some ground by the close. I will continue holding this stock.

[David Randolph]

Heavy profit taking on AVII, no surprise, this will be a roller coaster ride, but in the end, 2 months from now, I'm positive that I will be selling these stocks much, much higher than I bought them.

The Bird Flu bubble mania is just starting. I'm on that train and won't be thrown out of the window. I see room for immense speculation and since I am a speculator, I must be in. Buy the rumor, sell the fact, even if later nothing happens one should buy now.

I'm not even a bit worried about today's sell off and I'll continue holding AVII.

[puenthouse]

UGH... cant find anything significant news, but not a fun drop.

[422fwhp]

It's never fun to see the money value go down but just remember, "the trend is your friend."

It's probably just profit taking as usual after a good run.  It will eventually test the trendline support seen in David's previous chart...could be a much higher price or it could happen tomorrow.  I'm not that good so I'll stick with the plan.

If it happens tomorrow just look at it as a buying opportunity.

Good luck and happy trading.

[puenthouse]

Thanks 422fwhp,  I unlike dave  have not learned the lesson to double down and Ibought more when it hit close resistance today.  Why not get it on the bottom?  Daves stocks always or atleast the majority of the time have a histroy of bouncing of resistance numerious times.  and if it falls thru, Ill be there selling with ya.

[Ramsburg]

Good Morning !

David will not be able to post the regular daily updates today. But he gave me instructions to Hold this position on AVII.

I'll just post an updated chart.

[David Randolph]

I see rising days with a lot of volume and interest and falling days with much less volume that look like profit taking. Why this assumption? Because if volume is low on the corrective days, it means not everybody that bought on the strong white candles is selling, just some of them taking profits, the majority of investors are buying for longer term purposes.

I'm on that camp and it looks like the corrective phase is getting to an end (not a new low today). Another powerful white marubozu will probably take AVII to new highs over the coming days/weeks.

My safety net is the ascending trendline (tomorrow at $2.90). If the stock ever closes below that line I have to admit the trend is no longer bullish and I don't want stocks in my portfolio that are not rising in value in trend terms.