China firm eyes quick approval of drug to cure Ebola

[TaiShang]

China firm eyes quick approval of drug to cure Ebola

This picture taken on Aug 19, 2014 shows quarantine officers inspecting the Alpha Friendship, a bulk carrier registered in Greece that carries ores from the Pepel port in Sierra Leone, one of the Ebola-hit area in Western Africa, as the ship berths in the quarantine anchorage waiting for its entry in the port at Qingdao, in East China's Shandong province. [File photo]

A Chinese drug maker is seeking fast-track approval for a drug that it says can cure Ebola, as China joins the race to help treat a deadly outbreak of a disease that has spread from Africa to the United States and Europe.

Sihuan Pharmaceutical Holdings Group Ltd has signed a tie-up with Chinese research Academy of Military Medical Sciences (AMMS) last week to help push the drug called JK-05 through the approval process in China and bring it to market. The drug, developed by the academy, is currently approved for emergency military use only.

"We believe that we can file to the Chinese Food and Drug Administration (CFDA) before the end of the year," Sihuan's chairman Che Fengsheng said during an investor call last week.

"They are looking at this very seriously... and we could get on the 'green light' track," he added.

Sihuan's drug is only one contender among a number of experimental cures worldwide to treat Ebola, although if successful it would be a huge boon for China's developing pharmaceutical sector and the country's soft power in Africa, an increasingly important partner for the world's No 2 economy.

The current outbreak, the worst on record of the disease, has killed more than 4,000 people, mostly in West Africa.

Tested on mice

China's Ebola cure bid still lags some way behind US-developed ZMapp and TKM-Ebola, but Sihuan management said the drug has proven effective during animal testing on mice.

The drug, which AMMS has been studying and developing already for five years, is similar to Japanese flu drug favipiravir, developed by Fujifilm Holdings Corp, which has been used effectively to treat patients with Ebola.

ZMapp and TKM-Ebola have been tested on monkeys, which give a closer immune response to that of humans, and have been used to treat human patients with the disease.

JK-05 has not yet undergone clinical trials, but Sihuan management said the firm was actively working towards clinical tests of the drug, which could be shorter than normally required. The drug has also shown promise against diseases such as influenza and yellow fever.

Chinese doctor Wang Hongquan, credited with inventing the drug, said on the investors call that JK-05 would first be used to treat Chinese nationals working in Africa with the disease, but treating non-Chinese would require further international approvals.

There are millions of Chinese nationals living in Africa, with around 10,000 in the worst affected countries - Sierra Leone, Guinea and Liberia.

JK-05 could also be used if Ebola spreads to China.

"We can't rule out the possibility that it will spread to Asia. Particularly in China now we have lots of connections with different international cities and many people coming and going across our borders," he said on the call.

 

[vietnamese_sausage]

Strange, the common flu kill 36000 US citizen per year yet no one is looking into a cure.

 

[TaiShang]

Strange, the common flu kill 36000 US citizen per year yet no one is looking into a cure.

Maybe financial foes?

Ebola vaccine research stalled by budget cuts - NIH director
Published time: October 13, 2014 16:29

Reuters / James Akena

The United States would have had an Ebola vaccine ready by the time the virus had traveled across the Atlantic Ocean from West Africa if not for budget cuts that prevented scientific research, according to a top US health official.

"Frankly, if we had not gone through our 10-year slide in research support, we probably would have had a vaccine in time for this that would've gone through clinical trials and would have been ready,” National Institutes of Health (NIH) Director Dr. Francis Collins told The Huffington Post. NIH is the United States government’s primary biomedical and health research arm

Insufficient funding has not only hindered efforts for a vaccine - which Collins said NIH has worked on since 2001. Therapeutic measures to fight the virus, also "were on a slower track than would've been ideal, or that would have happened if we had been on a stable research support trajectory."

"We would have been a year or two ahead of where we are, which would have made all the difference,"Collins told Huffington Post on Friday, two days before a Dallas nurse who had treated Ebola patient Thomas Eric Duncan at Texas Health Presbyterian Hospital wasconfirmed to have contracted the virus.

Funding for the NIH has gone up just over $1 billion in the past decade, before adjusting for inflation, from $28.03 billion in fiscal year 2004 to $29.31 billion in FY 2013. Meanwhile, spending for a sub-agency known as the National Institute of Allergy and Infectious Diseases has fallen slightly since FY 2004 to $4.25 billion.

Francis Collins, director of the National Institutes of Health (Reuters / Danny Moloshok)


Stagnant budgeting on research for the likes of infectious-disease vaccines has left NIH and other health agencies grasping for viable solutions as the current Ebola outbreak that began in West Africa threatens to spread further.

Emergency funding?
The latest Ebola crisis - which has claimed at least 4,000 lives, mostly in the West African countries of Liberia, Guinea, and Sierra Leone - has yet to compel lawmakers in Washington to approve emergency funding.

“Nobody seems enthusiastic about that,” Collins said, thoughlegislation has been introduced to boost the NIH budget up to $46.2 billion by 2021.

In the meantime, he said NIH has had to "take dollars that would've gone to something else and redirect them to [Ebola].”

Collins said the best outlook now would be for a clinical trial to begin in December, which it would then take another few months to determine if the drug actually worked.

"If we wait that long to solve this, we will have basically failed with the more traditional measures of contact-tracing to get this epidemic under control," he said, referring to efforts outside of vaccine research.

NIH’s current Ebola vaccine has had positive test results, Huffington Post reported, yet research has been conducted on monkeys, not humans. Limited trials on people have begun in earnest. A vaccine is also being developed in Canada, though it is not quite as far along as NIH’s drug.

The two “candidate” vaccines "have given very promising results in monkeys, but monkeys are not humans," Marie-Paule Kien, assistant director general for the World Health Organization, said last month according to AFP.

NIH headquarters (Image from wikipedia.org)


Collins said, though, that trials for potential vaccines cannot be rushed.

"Sometimes vaccines not only don't work, they make things worse," he said. "Look at the HIV step trial, where that vaccine not only did not protect HIV, it increased susceptibility because it did something to the immune system that made it more vulnerable. That could happen here too."

The experimental drug mixture known as ZMapp has been used to treat patients that have contracted Ebola, yet a low supply of it can be blamed on, again, a lack of funding.

"Had it not been for other shortages, we might very well by now know that it works and have a large stock of it," he said.

Other options like Brincidofovir, used to treat some virus carriers, including Duncan before he died on Oct. 8, could help some in the short-run, Collins said, but it is yet to pass adequate clinical trials.

Russia, meanwhile, recently announced that it will soon send to West Africa an experimental drug with 70 to 90 percent efficiency in fighting Ebola.

 

[bobsm]

Strange, the common flu kill 36000 US citizen per year yet no one is looking into a cure.

Case fatality rate for Ebola can reach as high as 90%.

 

[vietnamese_sausage]

Case fatality rate for Ebola can reach as high as 90%.

Only 4000 has died so far from Ebola.

 

[liall]

Only 4000 has died so far from Ebola.

During 1347-1350 black death wiped out half the population of Europe. If the rest of the world wasnt helping Africa right now 100s of millions would be dead in that continent.

 

[SvenSvensonov]

I wish the best of luck to our Chinese friends, but hope they take caution to avoid rushing needlessly. More competition is great for global prices and supply, though I don't think supply will become an issue as Ebola isn't too virulent, but as drugs can cause harm as well as help, I hope these firms test, test and retest to ensure they are presenting the best possible product.

SvenSvensonov

 

[Aepsilons]

During 1347-1350 black death wiped out half the population of Europe. If the rest of the world wasnt helping Africa right now 100s of millions would be dead in that continent.

There are many independent variables that are linked to the high mortality in Africa; 1) poor hygiene, 2) poor use of contraception, 3) backwards thinking that negates modern health care, for one of shamanism, witchcraft.

So long as these variables are not addressed, we're only playing a cyclic game with Africa.

 

[bobsm]

Only 4000 has died so far from Ebola.

The point is not how many have died, but how many are still alive after contraction. Let's take the common flu as an example. There are approximately 20k to 40k deaths annually, but that is out of millions(5 to 20% of population) infected. As you can see, the chances of you not dying, after contracting the common flu, is quite high. For ebola, it is the opposite. Once contracted, you have up to 90% chance of not surviving, hence the large effort in finding a cure.