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

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

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setravis

Reversal..... ;D    Breakout.....


PORTLAND, Ore., Jan 04, 2006 (BUSINESS WIRE) -- AVI BioPharma, Inc. (AVII, Trade), today announced that President Bush has approved the final version of the 2006 defense appropriations act, which includes an allocation of $11 million to fund AVI's ongoing defense-related programs. AVI's NEUGENE(R) technology is being used to develop therapeutic agents against Ebola, Marburg and dengue viruses, as well as to develop countermeasures for anthrax exposure and antidotes for ricin toxin.

"This funding allocation is evidence of the success of our antiviral and biodefense programs," said Alan P. Timmins, president and COO of AVI. "We're pleased that the government has increased the funding of our programs so substantially over last year's allocation. While this allocation is less than the Senate Appropriations Committee announced in early October, the difference is understandable given the huge financial impact of Hurricane Katrina. Still, this final funding level more than doubles the funding we received through the congressional defense spending bill for FY2005, and thus demonstrates the ongoing commitment to our programs."

In 2004, AVI received a $5 million allocation for fiscal year 2005 through the Department of Defense. The funds were used to evaluate AVI's NEUGENE antisense agents against Ebola and Marburg viruses and anthrax and ricin toxins in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). AVI also signed a collaborative research agreement with the Centers for Disease Control and Prevention (CDC) last year to test the company's NEUGENE antisense agents against all four serotypes of the dengue virus. This successful program will continue under the funding allocation for 2006.

NEUGENE antisense compounds are synthetic polymers that mirror a critical portion of a disease-causing organism's genetic code, which bind to specific portions of the target genetic sequence. Like a key in a lock, NEUGENE compounds are designed to match up perfectly with a specific gene or viral sequence, blocking the function of the target gene or virus.

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 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 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. It is caused by a genetically unique animal-borne RNA virus, whose 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, the Democratic Republic of Congo, in 1998, when 123 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, in order 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 B. anthracis: edema toxin, lethal toxin, and an antiphagocytic capsular antigen. The lethal toxin is the most important in pathogenesis and is 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%. Following the bioterrorist attack in fall 2001, the case-fatality rate among patients with inhalation disease (all of whom received antibiotic therapy) was 45% (five of 11).

 
Technicals
Percentage Gainer

Last Price Quote is:
15.65%above 13-day EMA
20.50%above 50-day EMA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $152.44 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 03/07/2006
Last Analyst Rating: Sell
"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

Quote from: metro on January 06, 2006, 11:12:14 AM
Real nice break out today! First the bottom level and all the way to the top


Very Nice indeed ! ;D
I have other on this thread


  http://www.3stocksonfire.org/trading/index.php?topic=3160.new#new

"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

fous

Nice job on this one setravis Applauds. Close above 4.04 and you can count me in ;D

-fousc

P.S. my chart should say 4.04 :P

trade it like you mean it!

fous

In today just before the close at 4.08.

Broke out of an ascending triangle with above average volume confirmation. Like to see this one ride next week.

Are you in Setravis?

-fousc
trade it like you mean it!

setravis

Quote from: fousc on January 06, 2006, 12:11:09 PM
Nice job on this one setravis Applauds. Close above 4.04 and you can count me in ;D

-fousc

P.S. my chart should say 4.04 :P


Quote from: fousc on January 06, 2006, 05:09:54 PM
In today just before the close at 4.08.

Broke out of an ascending triangle with above average volume confirmation. Like to see this one ride next week.

Are you in Setravis?

-fousc

Surging today!
Oh yes...I'm in. Been holding for some time now. ;)
Thanks for the chart work and the vote of confidence = return Applaud.
Good luck with your trade...make some $greens$ ! ;D
Chart does look nice. MACD bounced off center, north bound.
IMHO,Looks like $5 is an easy target now.
Volume was good.
Volume: 2,827,980
Avg Vol (3m): 1,242,000

Technicals
MACD - Bullish
Percentage Gainer

Last Price Quote is:
14.25%above 13-day EMA
19.04%above 50-day EMA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $152.44 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 03/07/2006
Last Analyst Rating: Sell


"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

AP
AVI BioPharma Posts Good Study Results
Tuesday January 10, 10:36 am ET 
AVI BioPharma Says Its Hepatitis C Drug Proved Safe and Active in First Phase of Study


PORTLAND, Ore. (AP) -- Drug developer AVI BioPharma Inc. said Tuesday that its experimental hepatitis C treatment appeared active and safe in the first stage of a study.
The company said similar drugs developed by other companies have often been limited by serious side effects at higher doses.

AVI's shares jumped 28 cents, or 7 percent, to $4.33 in morning trading on the Nasdaq.

The drug firm tested the treatment, called Neugene, on 30 healthy volunteers at three dosage levels. AVI said there were no serious side effects, adding that the drug reached its heaviest blood concentration in about four hours after injection.

AVI said it plans to continue the study with a target dose between 100 milligrams and 300 milligrams. The company tested doses of 50 milligrams, 100 milligrams and 300 milligrams.

The second phase of the study will include up to 40 patients with chronic, active hepatitis C. The disease is characterized by liver inflammation and can eventually lead to liver cancer or failure.



"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

Breakout...... 8)
+8.15%......Volume @.......1,452,838

Technicals
Record Price High
Gap Up
Percentage Gainer

Last Price Quote is:
16.73%above 13-day EMA
24.27%above 50-day EMA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $180.71 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 03/07/2006
Last Analyst Rating: Sell
"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.


AVI BioPharma Reports Favorable Safety and Pharmacokinetic Data From Its Clinical Trial Targeting Hepatitis C Virus
Tuesday January 10, 9:00 am ET 
NEUGENE Antisense Compound Was Well-Tolerated and Exhibited Favorable Pharmacokinetic Parameters


PORTLAND, Ore.--(BUSINESS WIRE)--Jan. 10, 2006--AVI BioPharma, Inc. (Nasdaq:AVII - News), today announced favorable safety and pharmacokinetic results from the first phase of its clinical trial for chronic active hepatitis C virus (HCV). The multicenter study is designed to assess the safety, tolerability, pharmacokinetics (PK) and viral response to daily subcutaneous administration of its proprietary NEUGENE® antisense compound AVI-4065 among healthy volunteers and patients with HCV.


"There is a large, unmet medical need for effective HCV treatments, as the current therapy is successful in less than half of the patients infected with genotype 1 HCV, the most common form of the virus in the U.S.," said Denis R. Burger, Ph.D., chief executive officer of AVI. "In addition, the current treatment regimen with interferon and ribavirin is expensive, has a plethora of side effects, and is not well-tolerated by many patients. The favorable safety and PK data reported today provide further evidence for the large potential therapeutic window for NEUGENE antisense drugs. This is in sharp contrast to previous antisense failures by other companies with other antisense chemistries, which have been primarily due to dose-limiting toxicity."

The first phase of this study has been completed by enrolling and evaluating approximately 30 healthy volunteers at three dosage levels of AVI-4065. Trial participants have received 50 mg, 100 mg or 300 mg of study drug by subcutaneous injection daily for 14 days, with each dose level evaluated for safety and tolerability, and a PK analysis conducted.

No serious drug-related adverse events occurred at any dosage level. All dosages were well-tolerated with no injection site reactions or events that required intervention. The apparent plasma elimination half-life ranged from 10 hours to 12 hours with a peak concentration at about four hours after subcutaneous injection. The PK profile suggests that the target dosage for efficacy phase of this trial will fall between the 100 mg and 300 mg dosages.

Dr. Mark Holodniy, FACP, professor of medicine at Stanford University School of Medicine and director of the Department of Veterans Affairs Public Health Research & Consultation Program in Palo Alto, Calif., principal investigator for the trial, said, "I am pleased to participate as an investigator at one of many study sites in the rigorous clinical testing of AVI's lead compound targeted to the HCV virus. The study should provide a better understanding of the compound's safety, pharmacokinetics and potential biological effects against HCV."

In addition to this clinical trial, a supporting safety and PK study has been completed in nonhuman primates. Groups of primates received daily injections of up to 40 mg/kg AVI-4065 for 28 days or about 15 times the largest human dose used, and for twice the duration. No serious adverse events, toxicities or tolerability issues were observed. Importantly, the liver accumulation of AVI-4065 was found to be approximately three times the plasma concentration. These data allowed for a direct calculation of the potential liver concentration of drug in humans from the clinical cohorts.

Together with the primate data, calculations from the first phase of the clinical study provide the basis for a dosage regimen for the second efficacy phase. The second phase will include up to 40 patients with chronic active HCV, stratified into two cohorts, one composed of patients who have not received previous treatment and the other composed of patients who have failed conventional interferon and ribavirin treatment.

The study will continue to assess the safety, tolerability and pharmacokinetics in addition to efficacy, as measured by HCV virological responses over a minimum of 14 days of treatment. Patients will also be monitored following treatment to assess the duration of the HCV virological response to AVI-4065. Preliminary data from the second phase of this program are expected in the first quarter of 2006.

HCV is a single-stranded RNA virus. Because HCV and other single-stranded RNA viruses have relatively simple genetic structures, they are attractive targets for AVI's NEUGENE antisense, which is designed to target conserved portions of the viral genetic code that are not likely to mutate over time.

About Hepatitis C Infection

Chronic HCV infection causes an inflammation of the liver that can result in the development of cirrhosis, liver cancer or liver failure. According to the World Health Organization, approximately 170 million people worldwide are chronically infected with HCV. It is the most common chronic blood-borne infection in the developed world and the leading cause of liver transplants in the U.S. The Centers for Disease Control estimates that approximately 3.9 million Americans have been infected with HCV, of whom 2.7 million are chronically infected.

The Hepatitis Foundation International estimates that between 8,000 and 10,000 people die annually in the U.S. from HCV-related cirrhosis or liver cancer. The current treatment for HCV, 24 to 48 weeks of therapy with pegylated interferon alpha and ribavirin, is successful in less than half of the patients infected with genotype 1 HCV, the most common form of the virus in the U.S. Furthermore, this treatment has numerous side effects, some of them severe, which make it difficult for nearly half of initially treated patients to tolerate the recommended dosages and duration of treatment.

"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

fous

nice strong close today :) still holding.

-fousc
trade it like you mean it!

setravis

Looking good Fousc ..... ;)
Congrats on the Stock Picking Contest....Job well done! Applaud!!!!  ;D
Good Luck with your trade on AVII....

Thanks for the chart work update on AVII.
There is more to AVII than meets the eye,bird flu stocks are pretty much flat on their back now.AVII is in phase I and II trials on their hepatitis C drug and finishing phase I on a cancer drug.The results of those tests are expected anytime now. IMHO, I think that a lot of this runup is because of the expected release of trials news very soon. If the trials are successful, AVII could jump again Only MHO of course.
AVII is pulling in substantial revenues and revenue growth has increased several hundred % over the last year.This is not a fly-by-night company, but a solid growth company.

Support @ $4.20...4.00...3.74
Resistance...Have to look at a 3 year chart to see the longer term resistance.
Somewhere around the areas of $5.00...5.50...6.00 I will post that chart here.

Volume: 2,777,578
Avg Vol (3m): 1,265,540

Technicals
MACD is Bullish
Stochastic is Bearish
Record Price High
Gap Up
Percentage Gainer

Last Price Quote is:
21.31%above 13-day EMA
29.15%above 50-day EMA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $180.71 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 03/07/2006
Last Analyst Rating: Sell
"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 gets good results from drug test
Tuesday January 10, 2:36 pm ET


AVI BioPharma Inc. said Tuesday that its experimental hepatitis C treatment is active and safe in the first stage of a study.
Portland-based AVI (NASDAQ: AVII - News) tested the treatment, called Neugene, with three dosage levels -- 50 milligrams, 100 milligrams and 300 milligrams -- on 30 healthy volunteers.

AVI said there were no serious side effects.

The second phase of the study will include up to 40 patients with chronic, active hepatitis C.

The disease causes liver inflammation and can eventually lead to liver cancer or failure.

Published January 10, 2006 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

stocks2watch2

AVII AVI BioPharma's NEUGENE shows success against deadly ebola virus; results published in Online Journal Public Library of Science Pathogens (4.62 ) 

Co announces the publication of significant research carried out in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases. The report, published today in Public Library of Science Pathogens demonstrates success using AVI's proprietary NEUGENE antisense technology as a countermeasure to Ebola virus infection. The extensive study results showed that a combination of Ebola-specific NEUGENE agents protected rodents in both pre- and post-exposure therapeutic regimens. In addition, in a proof-of-principle trial the investigators showed that administration of Ebola-specific NEUGENE agents before lethal exposure to the Ebola virus protected 75 percent of rhesus macaque monkeys in the trial.

phabrux

Some news for AVII today:

PORTLAND, Ore., Jan 13, 2006 (BUSINESS WIRE) -- AVI BioPharma, Inc. AVII, today announced publication of significant research carried out in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The report, published today in Public Library of Science (PLoS) Pathogens, a peer-reviewed monthly journal published by the Public Library of Science, demonstrates success using AVI's proprietary NEUGENE(R) antisense technology as a countermeasure to Ebola virus infection.

"Gene-Specific Countermeasures against Ebola Virus Based on Antisense Phosphorodiamidate Morpholino Oligomers" is publicly available and can be accessed from the PLoS Pathogens Web site at http://pathogens.plosjournals.org.

The extensive study results showed that a combination of Ebola-specific NEUGENE agents protected rodents in both pre- and post-exposure therapeutic regimens. In addition, in a proof-of-principle trial the investigators showed that administration of Ebola-specific NEUGENE agents before lethal exposure to the Ebola virus protected 75 percent of rhesus macaque monkeys in the trial.

"This is the first successful antiviral intervention against this class of viruses in nonhuman primates," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "These findings serve as the basis for development of a whole class of gene-specific drugs that can be quickly produced in response to known, emerging or genetically engineered bioterrorism threats."

Earlier this month, AVI announced that President Bush has approved the final version of the 2006 Department of Defense Appropriations Act, which includes an allocation of $11 million to fund AVI's ongoing defense-related programs. AVI's NEUGENE technology is being used to develop therapeutic agents against Ebola, Marburg and dengue viruses, as well as to develop countermeasures for anthrax exposure and antidotes for ricin toxin.

"We are making great strides in building the credibility for our third-generation NEUGENE antisense as a highly specific gene-targeting therapy," said Alan P. Timmins, president and COO of AVI. "Today's report shows not only how effective this approach can be, but it is also encouraging for our work in treating additional viral diseases, such as chronic hepatitis C infection, which currently affects an estimated 170 million people worldwide."

NEUGENE antisense compounds are synthetic polymers designed to mirror a critical portion of a disease-causing organism's genetic code and bind to specific portions of the target genetic sequence. Like a key in a lock, NEUGENE compounds are designed to match up perfectly with a specific gene or viral sequence, blocking the function of the target gene or virus.

About Ebola Zaire

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 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.

Ebola Zaire 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 infection.

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.

SOURCE: AVI BioPharma, Inc.


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

Copyright Business Wire 2006

stocks2watch2

UP .46  new 52 week high,on high volume.
Bid-5.08
Ask-5.09
Volume-4,264,000

setravis

AP.............................................................. ;D
AVI BioPharma Hits New 52-Week High
Friday January 13, 11:32 am ET 
AVI BioPharma Hits Fresh 52-Week High After Neugene Animal Ebola Virus Data Published

PORTLAND, Ore. (AP) -- AVI BioPharma Inc. shares hit a new 52-week high Friday after the drug developer said a published study showed that its Neugene antisense treatments protected animals against the fatal Ebola virus.
 
Shares of AVI rose 30 cents, or 6.5 percent, to $4.92 in morning trading on the Nasdaq, at more than double their average volume. Shares surpassed a previous 52-week high of $4.81 to peak at $5.15 earlier in the day.

Published on the peer-reviewed Public Library of Science Pathogen Web site, the study shows that mice given Neugene treatments before and after exposure were protected from the Ebola virus. Also, researchers found that 75 percent of rhesus macaque monkeys given Neugene treatments after exposure to the virus survived.

The company is researching Neugene in collaboration with the Army Medical Research Institute of Infectious Diseases. AVI reported earlier that the Defense Department had budgeted $11 million to fund the company's ongoing defense-related programs. Neugene is being developed to combat Ebola, Marburg and dengue viruses, anthrax exposure, and ricin toxin exposure.

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

• Health Stocks in Motion
at TheStreet.com (Fri 2:42pm)
 
• AVI therapy effective against Ebola
bizjournals.com (Fri 12:38pm)

• AVI BioPharma Hits New 52-Week High
AP (Fri 11:32am)
 
• AVI BioPharma's NEUGENE Shows Success Against Deadly Ebola Virus
Business Wire (Fri 9:00am) 


Headline News Link: To all articles today.
http://finance.yahoo.com/q/h?s=AVII

Up in the After Hours :
AVI BIOPHARMA INC (NasdaqNM:AVII) Delayed quote data 
After Hours (RT-ECN): 5.63  0.25 (+4.65%)

"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