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Old 08-13-2014, 05:22 PM   #26
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I know that it's publicly traded so I'm assuming that any trading has been stopped due to the significance of this pending announcement.

I'm looking for more.
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Old 08-13-2014, 05:31 PM   #27
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Got it. Trading was suspended due to earnings announcement. It will resume trading at 5pm ET.

Tekmira Says 'Evaluating Options' For Ebola Drug

Tekmira Pharmaceuticals shares were down 7% after hours after the company announced second quarter earnings that missed expectations.

Tekmira also said it's, "carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols."

Regarding its Ebola treatment, Tekmira said in its earnings press release that:

The single ascending dose portion of the TKM-Ebola Phase I clinical trial has been successfully completed in healthy human volunteers. As per the protocol maximum tolerated dose (MTD) was established to be 0.3 mg/kg for healthy subjects without steroid premedication.

In July, we received notice from the U.S. Food & Drug Administration (FDA) that our TKM-Ebola program was on clinical hold. Subsequently, the company received written notice from the FDA modifying the clinical hold to a "partial clinical hold," allowing for the potential use of TKM-Ebola in individuals who have a confirmed or suspected Ebola infection. The company remains on clinical hold as it relates to the multiple-ascending dose portion of the Phase I clinical study in healthy volunteers with TKM-Ebola. The company expects this matter to be resolved by Q4 2014.

Our therapeutic, TKM-Ebola, is currently an unapproved agent and the regulatory framework to support its use in Africa has not yet been established. Given the severity of the situation, we are carefully evaluating options for use of our investigational drug within accepted clinical and regulatory protocols. This includes discussions with government agencies and NGO's, including the WHO, in various countries on the potential use of TKM-Ebola to treat Ebola virus infected individuals. There can be no assurance that an appropriate framework for the use of this product will be found. We will continue to provide updates as necessary when clinical and regulatory pathways become confirmed.

In the second quarter, the company lost $0.28 per share compared to analyst expectations for $0.26 on revenue of $1.8 million against expectations for $3.69 million...
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Old 08-13-2014, 05:36 PM   #28
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I think you're right - the stock price has doubled since Thursday:

http://www.cbc.ca/news/business/tekm...gain-1.2733134

---------- Post added at 05:36 PM ---------- Previous post was at 05:32 PM ----------

We posted at more or less the same time. If I really wanted to take a flyer & I don't, I'd look at putting a chunk of purely speculative change into their stock. But there's a reason I avoid biotech...
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Old 08-13-2014, 06:07 PM   #29
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Quote:
Originally Posted by CanadaSue View Post
I think you're right - the stock price has doubled since Thursday:

http://www.cbc.ca/news/business/tekm...gain-1.2733134

---------- Post added at 05:36 PM ---------- Previous post was at 05:32 PM ----------

We posted at more or less the same time. If I really wanted to take a flyer & I don't, I'd look at putting a chunk of purely speculative change into their stock. But there's a reason I avoid biotech...
I treat biotech stocks like Ebola itself - I stay far, far away from them. One must remember that these companies have every incentive at the moment to hype up their products as much as possible, and with biotech stocks that is tantamount to pumping up their stock prices because that is all these companies have.
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Old 08-13-2014, 06:09 PM   #30
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Yup. If they hit with something good - awesome!

But the odds of that are ridiculously low.
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Old 08-13-2014, 06:27 PM   #31
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Quote:
Originally Posted by Sysiphus View Post
I treat biotech stocks like Ebola itself - I stay far, far away from them. One must remember that these companies have every incentive at the moment to hype up their products as much as possible, and with biotech stocks that is tantamount to pumping up their stock prices because that is all these companies have.
Not to be mercenary about this but...

From my reading about TKM-Ebola, I knew that their earnings statement was about due, but didn't go to the trouble to see what analysts were forecasting. But I must admit, when I saw that hold on trading, I wondered if it might be because they were getting a cash infusion or loan guarantees or something from a UN-associated organization to help them ramp up production.

I'm kind of looking for the same type of thing for Mapp Biochem and/or BioLeaf, or parent company Dreyfus.

But even so, I wouldn't touch any of these biotech's with a 10 ft. pole. The costs, permit processes and requirements of multi-national regulations that will be needed for a huge increase in production and distribution, and the potential pitfalls and liabilities of use in this current outbreak are going to be massive. And, once this outbreak is over, the market for their Ebola drug will shrink back to what it usually is - small and poor.
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Old 08-13-2014, 06:30 PM   #32
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Your DoD & Monsanto have thrown a bit of cash at them for various reasons. Chump change really & their losses were double the 3rd quarter year on year & their profits half.

Biotech is a very expensive gamble & the 'happy, happy" you very rarely get often proves to be based on wishful thinking & fudged testing.
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Old 08-13-2014, 06:39 PM   #33
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Quote:
Originally Posted by Sysiphus View Post
I treat biotech stocks like Ebola itself - I stay far, far away from them. One must remember that these companies have every incentive at the moment to hype up their products as much as possible, and with biotech stocks that is tantamount to pumping up their stock prices because that is all these companies have.

Quote:
Originally Posted by Catbird View Post
Not to be mercenary about this but...

From my reading about TKM-Ebola, I knew that their earnings statement was about due, but didn't go to the trouble to see what analysts were forecasting. But I must admit, when I saw that hold on trading, I wondered if it might be because they were getting a cash infusion or loan guarantees or something from a UN-associated organization to help them ramp up production.

I'm kind of looking for the same type of thing for Mapp Biochem and/or BioLeaf, or parent company Dreyfus.

But even so, I wouldn't touch any of these biotech's with a 10 ft. pole. The costs, permit processes and requirements of multi-national regulations that will be needed for a huge increase in production and distribution, and the potential pitfalls and liabilities of use in this current outbreak are going to be massive. And, once this outbreak is over, the market for their Ebola drug will shrink back to what it usually is - small and poor.
And ........ Even if they get hold harmless agreements from whomever they provide this to for them to then dispense / treat patients with and then some sort of waiver from the patient / informed consent, and there's any serious side effects........... Might be different in Africa, but here in the US that's a massive class action potential - I would think.

Though personally I'd look at it from this point: I have a disease with between a 50% to 90% mortality rate under the best conditions, without any 'known treatment' ..... I'd be inclined to give this medication a try based on some pretty grim statistics without it.
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Old 08-13-2014, 10:42 PM   #34
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A minor amount of cash but this may be just a beginning.

Governments scramble to develop Ebola drugs
Quote:
Governments and drugmakers are scrambling to develop new treatments for the Ebola virus now that the World Health Organization (WHO) has eased restrictions on untested vaccines.

The United States government is putting cash into experimental treatments, and on Tuesday, gave $4.1 million to the drugmaker BioCryst to advance its Ebola drug BCX4430, the company announced Wednesday.

The North Carolina pharmaceutical company in 2013 had received a five-year, $22 million contract from the National Institutes of Health (NIH) to develop the drug but is now being given extra funding to speed up trials.

"The ongoing Ebola epidemic in West Africa emphasizes the urgent need for safe and effective antiviral agents for hemorrhagic fever virus diseases. With these additional funds, BioCryst can move forward with important non-human primate efficacy studies, an [investigational new drug] filing, and Phase 1 human trials of intramuscular BCX4430," said William Sheridan, chief medical officer at BioCryst...
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Old 08-14-2014, 12:44 PM   #35
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Interesting. There are few details being reported about this drug. I did a quick search and didn't find any references to scientific studies about the use of this drug in treating Ebola.


‘Ebola drug’ arrives Nigeria today

Quote:
An experimental drug for treatment of Ebola has been provided by a Nigerian in diaspora and will arrive the country today, health minister Onyebuchi Chukwu, has said.

The drug, called “Nanosilver”, can now be used following the approval by the World Health Organisation (WHO) that experimental treatments are ethical in the case of the Ebola pandemic.

The Nigerian government authorised the use of experimental drugs on Wednesday.

...According to Chukwu, the experimental drug is a donation from a Nigerian scientist who was concerned about threat of Ebola in his home country.

“The drug will reach Nigeria today,” he said.
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Old 08-14-2014, 04:17 PM   #36
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lol Catbird, I bet you that "nano silver" turns out to be colloidal silver.
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Old 08-14-2014, 05:36 PM   #37
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That's what I assumed too Sonny.

The way I read it, the Nigerian gov't is authorizing the use of "Nanosilver" as an experimental cure because the WHO said it was ethical to use experimental treatments.

I'm watching to see if the WHO makes any comment about the use of colloidal silver as a cure for Ebola.
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Old 08-14-2014, 05:39 PM   #38
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http://www.nano-silver.com/
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Old 08-15-2014, 08:31 AM   #39
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Not exactly vaccine or therapy, but a good article on detection:

Quote:
Ebola control suffers from lack of fast detection tool

Karen Weintraub, Special for USA TODAY
8 a.m. EDT August 15, 2014


Early in August, when doctors worried that a patient at Mount Sinai Hospital in New York had Ebola, it took nearly three days to confirm that he didn't. And that was in one of the richest, most medically advanced cities in the world.

In Sierra Leone and neighboring Liberia, local hospitals have closed because no one can tell the difference between early Ebola and other common ailments. This means no one is getting care for other illnesses like malaria and the even deadlier Lassa fever, multiplying the misery there.

Detection will become particularly crucial when drugs are available to treat the virus, which has killed more than 1,000 people in four West African nations since late last year. No one will want to waste scarce medications on someone unless they are convinced the person has Ebola, said John Connor, a microbiologist at Boston University. and the drugs are more effective the earlier they are given.

"The faster you can diagnose, the better chance you have of giving therapy effectively," Connor said.

But diagnosing diseases in sub-Saharan Africa remains a challenge, despite years of research.

Current systems of detection involve large, expensive machines that depend on water and electricity, and require skilled technicians to operate and maintain. It took so long to diagnose the man at Mount Sinai, because his blood sample had to be shipped to the Centers for Disease Control and Prevention in Atlanta, which has one of the few labs in America that can diagnose Ebola.

Such a process is totally impractical in low-income countries like Sierra Leone and Liberia, which lack basic infrastructure. Liberia, a nation of 3.5 million, reportedly has just 50 doctors.
http://www.usatoday.com/story/news/n...inai/13969031/
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Old 08-15-2014, 09:32 AM   #40
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Never mind diagnostic issues with a suspect case - this just boggles my mind 8 months into the outbreak & 5 months into it becoming pretty widespread over there:

***[2] Temperature screening
Date: Thu 14 Aug 2014
Source: Liberian Observer [edited]
http://www.liberianobserver.com/news...ters-thousands


The Government of Liberia has begun testing citizens of 8 counties [districts] for the deadly Ebola disease. This testing of individuals is meant to control the spread from counties believed to be highly infected with the killer disease. Several counties, including Bomi, Lofa, Grand Cape Mount, Grand Bassa, Margibi Montserrado and Grand Gedeh, have been controlled to regulate the movement of people going in and out of those areas.

The Daily Observer recently discovered that the ... temperatures of those leaving from one area to another were tested by nurses assigned at various checkpoints using only 3 [clinical] thermometers. The testing process has been questioned by some segments of the Liberian society, including foreign nationals who visited Bomi over the weekend. Bomi County is among 8 counties quarantined by the Liberian government.

In an interview with the Daily Observer over the weekend [9-10 Aug 2014], Mr. Shang Guan, a Chinese national, said the intention of the government is good but is also dangerous to the health of citizens and foreigners alike. Mr. Guan refused to be tested with any of the 3 thermometers used by the county health team at the Bomi checkpoint. He said the use of manual thermometers to check the temperature of travelers as a means of containing the spread of the deadly virus was not the right thing to do. Experts have said that one way the deadly Ebola virus is spread is through contact with bodily fluids. Thermometers are either inserted in the mouth or under the arm, both of which involve the transfer of saliva and sweat respectively.

According to him, ... it would be prudent for authorities at the Health Ministry to use advanced rather than standard thermometers that do not involve physical contact with individuals. "I was worried about taking the test because even if you have malaria your temperature will be high and even if that person has EVD, it might spread to the others just by the use of so few thermometers," Mr. Guan said. He disclosed that what was even more scary to him was that all those who were being tested used the same 3 thermometers, with nurses having physical contact with travelers. Such a situation is highly risky for the people of Liberia. The Chinese national hailed Liberians as well as foreigners alike who have cooperated with the testing, but suggested that the limited thermometers being used must be well sanitized to avoid endangering the lives of others.

Another Liberian, Oscar Dolo, who was seen at the checkpoint, said the process was poorly coordinated by the county health authorities. He added that the process was hampering their free movement from one area to another. "I came since this morning and spent over 2 hours at this checkpoint. Those health workers who were to come early were the last to arrive, keeping us here for hours."***


http://www.promedmail.org/?p=2400:1000


Gack!
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Old 08-17-2014, 01:39 PM   #41
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Default Lagos State Will NOT Be Using Nano-Silver

The following article is an excellent description of how the possible use of nano-silver in Nigeria came about as well as a disussion of relevent research into the use of nano-silver. A short statement at the end of the artilce, (at link), simply states Lagos State will not be using nano-silver:

***Is using nano silver to treat Ebola misguided? August 15, 2014

Andrew Maynard

On Thursday this week, the Wall Street Journal reported that Ebola victims in Nigeria’s commercial capital Lagos will receive Nano Silver in an attempt to treat the infection. The news comes hot on the heels of the World Health Organization’s decision to sanction the use of unlicensed Ebola drugs in West Africa on ethical grounds. It also coincides with a US Food and Drug Administration statement released yesterday warning against fraudulent Ebola treatment products.

Is the use of nano silver a legitimate application of on unlicensed treatment, or cynical exploitation of a mounting humanitarian crisis? Having studied and written about the biological impacts of nano silver for some years now, I must confess I was surprised by the Nigerian decision.


Silver as an antimicrobial

Silver has been used as an antimicrobial agent for thousands of years – the Romans used to use silverware to reduce food and drink-borne infection. More recently, nanoparticles of silver have been used in everything from food containers to socks in an attempt to imbue them with microbe-killing properties.

When used in the right way, the material certainly does exhibit antimicrobial properties. But there’s a massive jump from odor-resistant socks to curing Ebola patients.



An Open Letter on Ebola Treatment to Nigeria’s President

The Nigerian decision to treat patients with nano silver seems to stem from an open letter to President Goodluck Jonathan from one Dr Rima E. Laibow.

As Dr. Laibow writes in her letter,

“There is, in fact, a well-established, non-toxic anti-microbial, without any known side effects, available at remarkably low cost which – • Requires no refrigeration • Is self-sterilizing. • Is readily available • Has a very long shelf life • Is not subject to degradation under temperature and humidity extremes. That nutrient substance is Nano Silver.”

Dr. Laibow is Medical Director of an organization called the Natural Solutions Foundation. And one of the products this organization sells is colloidal nano silver...***

more at link:



http://www.riskscience.umich.edu/nan...ctims-nigeria/
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Old 08-17-2014, 02:20 PM   #42
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Silver is an antimicrobial, i.e., antibacterial. I am aware of no evidence that it has reliable broad spectrum antiviral properties, especially in the doses which would be used in in humans. There is some patchy research on a few viruses, and some breathless promotion on the web (http://www.colloidalsilverkillsviruses.com), but I wouldn't feel very protected with a bottle of "colloidal" silver in Ebola territory.
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Old 08-18-2014, 09:21 AM   #43
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I'm very disappointed that World Heath Organization is not going to use any of the 1000 doses of Canadian made VSV-EBOV Ebola Vaccine to treat Doctors and Nurses who are being exposed to Ebola patients every day.

Are they saving it just in case there's a breakout somewhere outside of Africa? My understanding was it would be used to protect HCW's on the front lines NOW.

The World Health Organization says more than 170 healthcare workers have been infected and at least 81 have died. The death toll from Ebola is still climbing.

The Free vaccine gift from Canada should have come attached with a
"use it or loose it" clause.

The silence is deafening. the message is," You're not worthy"

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Old 08-22-2014, 11:14 AM   #44
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Approval of Ebola vaccine, Not this Year,
and Not next year ether.




Clinical trial to start soon on GSK Ebola vaccine

A clinical trial of an experimental vaccine against the deadly Ebola virus is set to start shortly, according to British drugmaker GlaxoSmithKline, which is co-developing the product with U.S. scientists.

GSK's experimental vaccine has already produced promising results in animal studies involving primates and it is now due to enter initial Phase I testing in humans, pending approval from the U.S. Food and Drug Administration.

A company spokeswoman said on Sunday that the trial should get underway "later this year", while GSK's partner the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement on its website it would start "as early as fall 2014", implying a potential September launch of testing.

Even if is fast-tracked, however, and emergency procedures are put in place, the new vaccine could not be ready for widespread deployment before 2015 - even assuming it works as well as hoped.
...

The U.S. NIAID - part of the National Institutes of Health - is also supporting work on other early-stage Ebola vaccines, including one from Johnson & Johnson's Crucell unit that should enter Phase I clinical testing in late 2015 or early 2016
~~~~~~~

Another related news article
Experimental Drugs Could See Action
...
There are at least three vaccines in development for Ebola that are garnering attention. One of the vaccines, developed by a government laboratory in Canada, has already been shipped to the World Health Organization, presumably for use in Africa. About 1,000 doses of the vaccine, licensed to NewLink Genetics, a company in Ames, Iowa, may be tested in first responders, including healthcare providers, according to reports. Charles Link, the chief executive, said NewLink could manufacture tens of thousands of doses over the next couple of months.

The NIH and GlaxoSmithKline (a company I advise on unrelated matters as a member of GSK’s Product Investment Board) are developing another vaccine. There are 400 doses available now, according to reports — enough for a clinical trial in healthy adults, federal official are saying.

The United Kingdom’s Telegraph reports that GSK is planning to test the vaccine on a small group of people at the NIH Vaccine Research Centre in Maryland later this year. As part of this process, the NIH will recruit health volunteers to inject them with the experimental vaccine. The aim of this early stage testing is see if the product is safe and helps people mount an immune response that would confer protection against a future exposure to Ebola. This process normally takes up to six months. GSK is hoping to report the results by the end of the year.

Bavarian-Nordic, a biotechnology company located in Denmark, also has a vaccine in development that can protect against multiple hemorrhagic fevers, including Ebola. The vaccine is based on the same platform that the company used to develop its smallpox vaccine Imvamune.

Among the companies developing therapeutics, a lot of the early attention has focused on Mapp Pharmaceutical’s product ZMAPP. This is a antibody drug (developed in a tobacco plant) that directly attacks the virus. It has already been studied in monkeys. In those trials, macaque monkeys were able to survive infection with Ebola, and develop a robust and durable immune response against the virus.
...
FDA issued a so-called “animal rule” almost a decade ago (amid fears of bioterrorism after the deadly anthrax attacks) outlining how a drug could be approved on the basis of only efficacy studies in animals. It was rightly acknowledged that animal testing alone would have to form the basis of approval when we were dealing with therapeutics that targeted rare and deadly diseases that could be used as weapons.

The same challenges surround drugs targeted to Ebola.
...
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Old 08-22-2014, 05:14 PM   #45
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WHO tempers hopes for experimental
Ebola drugs
and Vaccines


Kelly Grant and Geoffrey York
JOHANNESBURG — The Globe and Mail


The World Health Organization is warning against “unrealistic expectations” that experimental Ebola drugs – including vaccines offered by Canada – will be able to halt the spread of a West African outbreak whose death toll the agency says it has vastly underestimated.

The public health arm of the United Nations moved to tamp down hope about the efficacy and availability of untested treatments just days after its own ethics panel gave such tools a green light, a decision that accelerated the race to put experimental treatments into the hands of people on the front lines of a crisis that has killed at least 1,145 in four countries.

The WHO said it welcomed Canada’s offer of several hundred doses of an experimental Ebola vaccine. Neither the Public Health Agency of Canada nor the WHO offered any new information Friday about who might get those doses or when they might be used.

[The Canadian Vaccine knows as]
VSV-EBOV has protected the “hundreds” of primates on which it was been tested without adverse side effects, said Thomas Giesbert.

“There’s nobody in my lab that wouldn’t take this vaccine if they were allowed to,” said Thomas Giesbert, a professor of microbiology and immunology at the University of Texas Medical Branch and one of the scientists who played a key role in developing the vaccine.

The Public Health Agency of Canada did not respond to e-mailed questions about the vaccine Friday.
...

http://www.theglobeandmail.com/news/...ticle20086931/

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Old 08-25-2014, 10:57 AM   #46
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Default An Influenza drug sold in Japan?

The Japanese government said it is willing to provide a drug developed in its laboratories to treat Influenza.

Google translation from:
http://www.bbc.co.uk/afrique/monde/2...ola_t705.shtml

Favipiravir
called (or "T-705") and marketed under the name Avigan, it could be offered to patients in accordance with the manufacturer, Toyama Chemical.

Compared to the experimental treatment ZMapp, the T-705 has the advantage of having been approved in Japan in March as qu'antiviral against influenza.

It is currently undergoing clinical testing in the United States.
Experts say his administration as tablets may facilitate treatment in areas with limited medical facilities.

Japanese authorities want to make available to patients in countries affected by Ebola country

The secretary general of the Japanese government Yoshihide Suga said that Tokyo is "willing to deliver the drug in cooperation with the manufacturer if the World Health Organization (WHO) so requests"

There is currently no vaccine or antiviral approved against the Ebola virus, which is among the most contagious and deadly in humans which can cause death within a few days.

The ZMapp has cured two American doctors, but a Spanish priest who had benefited died.

The World Health Organization has approved mid-August the use of unapproved treatments.

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Old 08-25-2014, 11:15 AM   #47
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First time I've heard of it. I wonder what's it's mechanism of actrion is that would lead the Japanese to think it might be worth a shot against Ebola?
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Old 08-25-2014, 11:21 AM   #48
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ZMAPP

Recipients of ZMAPP:

Dr. Abraham Borbor, Deputy Chief Medical Doctor - John F. Kennedy Medical Center
Dead
Black

Dr. Aroh Cosmos Izchukwu, "a Nigerian Doctor"
Alive
Black

Ugandan doctor, "assisting at JFK"
Alive
Black

2 White American Doctors
Alive/Alive
Spanish priest,
White
Dead

Last edited by andy; 08-25-2014 at 11:26 AM.
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Old 08-25-2014, 11:29 AM   #49
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Here's an Ebola specific small animal study using the Japanses drug:

http://www.sciencedirect.com/science...66354214000576
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Old 08-25-2014, 11:40 AM   #50
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Quote:
Originally Posted by CanadaSue View Post
First time I've heard of it. I wonder what's it's mechanism of actrion is that would lead the Japanese to think it might be worth a shot against Ebola?
The mechanism of its actions is thought to be related to the selective inhibition of viral RNA-dependent RNA polymerase.





http://www.ncbi.nlm.nih.gov/pubmed/?term=Favipiravir

Results: 2, for Favipavir and Ebola




Select item 245831231.
Successful treatment of advanced Ebola virus infection with T-705 (favipiravir) in a small animal model.
Oestereich L, Lüdtke A, Wurr S, Rieger T, Muñoz-Fontela C, Günther S.
Antiviral Res. 2014 May;105:17-21. doi: 10.1016/j.antiviral.2014.02.014. Epub 2014 Feb 26.

PMID:24583123[PubMed - in process] Free Article








Select item 244626972.
Post-exposure efficacy of oral T-705 (Favipiravir) against inhalational Ebola virus infection in a mouse model.
Smither SJ, Eastaugh LS, Steward JA, Nelson M, Lenk RP, Lever MS.
Antiviral Res. 2014 Apr;104:153-5. doi: 10.1016/j.antiviral.2014.01.012. Epub 2014 Jan 24.

PMID:24462697[PubMed - in process]

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