COVID 19 - Japanese flu drug 'clearly effective' in treating coronavirus, says China

 

Patients given the medicine in Shenzhen turned negative in a median of four days 

Photograph: John Minchillo/AP

Japanese flu drug 'clearly effective' in treating coronavirus, says China

Shares in Fujifilm Toyama Chemical, which developed favipirav

Medical authorities in China have said a drug used in Japan to treat new strains of influenza appeared to be effective in coronavirus patients, Japanese media said on Wednesday.

Zhang Xinmin, an official at China’s science and technology ministry, said favipiravir, developed by a subsidiary of Fujifilm, had produced encouraging outcomes in clinical trials in Wuhan and Shenzhen involving 340 patients.

“It has a high degree of safety and is clearly effective in treatment,” Zhang told reporters on Tuesday.

Patients who were given the medicine in Shenzhen turned negative for the virus after a median of four days after becoming positive, compared with a median of 11 days for those who were not treated with the drug, public broadcaster NHK said.

In addition, X-rays confirmed improvements in lung condition in about 91% of the patients who were treated with favipiravir, compared to 62% or those without the drug.

Fujifilm Toyama Chemical, which developed the drug – also known as Avigan – in 2014, has declined to comment on the claims

Shares in the firm surged on Wednesday following Zhang’s comments, closing the morning up 14.7% at 5,207 yen, having briefly hit their daily limit high of 5,238 yen.

Doctors in Japan are using the same drug in clinical studies on coronavirus patients with mild to moderate symptoms, hoping it will prevent the virus from multiplying in patients.

But a Japanese health ministry source suggested the drug was not as effective in people with more severe symptoms. 

“We’ve given Avigan to 70 to 80 people, but it doesn’t seem to work that well when the virus has already multiplied,” the source told the Mainichi Shimbun.

The same limitations had been identified in studies involving coronavirus patients using a combination of the HIV antiretrovirals lopinavir and ritonavir, the source added.

In 2016, the Japanese government supplied favipiravir as an emergency aid to counter the Ebola virus outbreak in Guinea.

Favipiravir would need government approval for full-scale use on Covid-19 patients, since it was originally intended to treat flu.

A health official told the Mainichi the drug could be approved as early as May. 

“But if the results of clinical research are delayed, approval could also be delayed.”

Justin McCurry in Tokyo

theguardian

inngeniar

Microchip 'could improve detection of substandard drugs'

A new way of detecting substandard drugs will be put to field tests soon

Flickr/AnoLobb@healthyrx

A microchip tailored to detect a specific active ingredient in a drug that costs only a few US cents to produce could help in efforts to detect counterfeit and substandard medicines in the developing world, researchers say.

The replaceable microchip comes in a portable, shoebox-sized device, known as 'PharmaCheck'. It is equipped with a fluorescent probe that binds to an active ingredient in a drug sample and the strength of its glow indicates the quality and quantity of a specific ingredient inside a drug.

"It is like a light bulb being switched on or increasing in brightness, and this can be measured by something as simple as an iPhone," said Muhammad Zaman, an associate professor of biomedical engineering at Boston University, United States, and head of the team behind the chip. It is expected to complete field trials over the next two years and to cost 20 per cent less than existing technologies for detecting substandard drugs.

Zaman said the new approach is better than a one-size-fits-all strategy, because the probes for each type of drug are more accurate, sensitive and reliable, and chips have multiple channels for testing different ingredients. For example, they could be used to test combination therapies common in the treatment of malaria.

It is also possible to repeat tests and confirm results in the field, without sending results to a well-equipped laboratory, which may be far from rural communities.

Unlike existing 'lab in a van' technologies, the probe can measure both how a drug binds to the probe — to ensure it is not toxic or inactive — as well as the concentration of the active ingredient.

In many developing countries, legitimate medicines may become substandard due to manufacturing failure, poor storage facilities, exposure to sunlight or degradation, Zaman said.

Boston University is working on the new product in collaboration with the US government-funded 'Promoting the Quality of Medicines (PQM)' programme, which provides technical assistance to developing countries to ensure the safety of drugs, and is implemented by the US Pharmacopeial Convention (USP).

"We want to take the current technology to the next level," said Kennedy Chibwe, a senior programme advisor at USP. "At the moment we only get qualitative data on drug quality; we don't know the exact amount of drug in the medicines."

From the project's outset, the PharmaCheck team has ensured that the technology was suitable to implementation in the developing world, in relation to cost, access, mobility and available infrastructure, said Zaman. "Most competing technologies fail on one or more of these parameters."

But Zaman cautioned that "the limitation is not with the technology — as this works — but the issues at point-of-use, such as how much training is required and how fragile the chip might be".

Jamie Barras, a research fellow at King's College London, agreed that the training of practitioners will be integral to ensuring a sample is prepared according to strict protocols, to ensure reliability.*

*This article was ammended on 14 August to remove a comment by one of the commentators upon his request.

Rachel Mundy

scidev.net

For the First Time, Lab-Grown Blood Is Pumped Into a Human's Veins

Artificial blood may become a common reality, thanks to the first successful transfusion of lab-grown blood into a human.

Luc Douay, of Pierre and Marie Curie University, Paris, extracted hematopoietic stem cells from a volunteer's bone marrow, and encouraged these cells to grow into red blood cells with a cocktail of growth factors. 

Douay's team labeled these cultured cells for tracing, and injected 10 billion of them (equalling 2 milliliters of blood) back into the marrow donor's body.

After five days, 94 to 100 percent of the blood cells remained circulating in the body.

After 26 days, 41 to 63 percent remained, which is a normal survival rate for naturally produced blood cells. 

The cells functioned just like normal blood cells, effectively carrying oxygen around the body. 

"He showed that these cells do not have two tails or three horns and survive normally in the body," said Anna Rita Migliaccio of Mount Sinai Medical Center in New York.

This is great news for international health care.

"The results show promise that an unlimited blood reserve is within reach," says Douay. 

The world is in dire need of a blood reserve, even with the rising donor numbers in the developed world. 

This need is even higher in parts of the world with high HIV infection rates, which have even lower reserves of donor-worthy blood.

Other attempts to synthesize blood have focused on creating an artificial blood substitute, rather than growing natural blood with artificial means. 

For example, Chris Cooper of the University of Essex in Colchester, UK, is working on a hemoglobin-based blood substitute that is less toxic than the protein in its unbound state. 

Artificial blood substitutes present a solution for transfusions after natural disasters and in remote areas. 

The artificial substitutes do not require refrigeration, unlike fresh and stem cell-grown blood.

The stem cell method has its own pros, though. 

"The advantage of stem cell technology is that the product will much more closely resemble a red cell transfusion, alleviating some of the safety concerns that continue around the use of the current generations of artificial products," says Cooper.

While Douay's results, published in the medical journal Blood, are a major step forward, mass-produced artificial blood is still a long way away. 

A patient in need of a blood transfusion would require 200 times the 10 billion cells that Douay and his colleagues used in the test. 

Robert Lanza, one of the first people to grow red blood cells in a lab on a large scale, suggests using embryonic stem cells, which could generate 10 times the amount grown by Douay.

Sean Kane

popsci.com

[New Scientist]

Thousands of possible malaria drugs found

Scientists have discovered thousands of potential new drug compounds for tackling malaria.

Malaria, caused by a parasite carried by mosquitoes, kills hundreds of thousands of people each year, with the highest disease burden in Sub-Saharan Africa, and resistance to existing drugs threatens to make it even deadlier.

But now, two papers in Nature report on a variety of chemicals, each active against malaria parasites, and thus with the potential to be developed into a future drug.

Armand Guiguemde, of St Jude's Children's Research Hospital, United States, and his team screened some 310,000 chemicals and found more than 1,100 with promising anti-malarial effects [1].

Many of these targeted places on the malarial parasite different from the places targeted by current drugs. This means there is unlikely to be pre-existing resistance to the new compounds. In models, two worked well alongside artemisins.

In the second paper, Francisco-Javier Gamo of drug company GlaxoSmithKline's (GSK) Tres Cantos Medicines Development Campus in Spain, and his team screened nearly 2 million compounds from GSK's library, identifying 13,500 antimalarial chemicals [2].

Some 8,000 worked well against multi drug-resistant Plasmodium falciparum parasites, and some 11,000 that were previously property of GSK are now available to researchers for further study.

From today, the structures of the compounds will be available on public websites for the scientific community to use. It is the first time that a drug company has made public the structures of so many molecules

The research comes at a time when the first signs of resistance to the only fully effective antimalarial drugs — artemisins — are starting to emerge in South-East Asia.

Link to article in Nature
Link to first paper in Nature
Link to second paper in Nature

African countries should unite for drug development

African nations must pool resources to promote local pharmaceutical innovation, say Ibrahim Assane Mayaki and Carel IJsselmuiden.

Africa bears a quarter of the world's disease burden, yet accounts for less than one per cent of global expenditure on health.

About half of the continent's population lacks access to essential medicines and the few drugs that are available often come from outside — Sub-Saharan Africa imports nearly 90 per cent of its medicines.

A lack of pharmaceutical innovation and access to essential medicines within Africa is severely hampering the continent's ability both to discover and develop medicines that meet local public health needs, as well as to deliver drugs in a timely manner, at an affordable cost.

To invest in national pharmaceutical innovation, countries can focus on generating long-term economic benefits by strengthening their science and technology sectors and adjacent sectors, such as drug delivery infrastructure. Or they can focus on improving universal access to essential medicines.

Both approaches are viable and countries often mix the two objectives when considering innovation strategies. In the end, decision makers must be clear on the balance they want to achieve and craft a strategy that meets their goals — economic development, improved access, or both.

In either case, investing in pharmaceutical innovation would enable the continent to target drug development at diseases specifically affecting local populations, and to explore and use its wealth of traditional medicines.

Hints of promise

There are signs that African leaders are waking up to the need for local pharmaceutical innovation and production.

Thirty-seven countries on the continent now engage in some form of medicine production. Egypt and Tunisia, for example, have been particularly successful, meeting 60–95 per cent of their own drug needs.

But capacity for local production elsewhere in Africa is generally low and most 'production' consists simply of packaging, or reformulating existing active ingredients. South Africa is the only country to produce new active pharmaceutical ingredients.

The global health community — including multilateral health programmes, donors and UN agencies — has proved critical in providing affordable medicines to fight diseases neglected by profit-driven pharmaceutical manufacturers.

For example, the Onchocerciasis Control Programme (OCP) has significantly reduced river blindness in the past 40 years, and various initiatives to develop antiretrovirals for HIV/AIDS have dramatically increased the number of people treated in the past five years.

But for too long, international players have set the African agenda for health research and drug development.

It is imperative that countries be allowed to set their own priorities and formulate their own strategies to meet the needs of their people.

Taking control

Several African countries are now working to make this a reality. Kenya, Nigeria, South Africa and Tanzania, among others, have policies to guide investment in developing, producing and delivering medicines for their populations. These include Tanzania's national drug regulatory authority and the traditional medicines policies of Nigeria and South Africa.

Local pharmaceutical innovation is a principle agreed across the continent. All 55 members of the African Union (AU) have signed the Gaborone and Abuja Declarations supporting the development of an African pharmaceutical innovation plan.

And a recent initiative led by the New Partnership for Africa's Development (NEPAD), Strengthening Pharmaceutical Innovation in Africa, marks the first attempt to put African pharmaceutical innovation into practice.

At a February meeting convened by the AU and the Council on Health Research for Development in Pretoria, South Africa, African research, political and industry leaders approved an action plan to build countries' expertise in pharmaceutical innovation (see Africa plans leap into drug R&D).

At its meeting in March, the African Ministerial Council on Science and Technology (AMCOST) recognised this initiative as a key ingredient in implementing the AU's Pharmaceutical Manufacturing Plan for Africa.

It will also prove indispensable in implementing the WHO's Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, which will be discussed next month by representatives of 193 countries at the World Health Assembly.

But limited infrastructure and skills mean that the prospect of lab-to-patient innovation systems remains a distant dream for many African countries.

Team effort

Much quicker progress could be achieved by pooling resources across regions. Working through 'Regional Economic Committees', individual countries could decide which skills to develop and craft strategies to attract investment to the region, calling on international expertise as needed.

Opportunities for regional cooperation include sharing medicines registration, quality control, clinical trials, education and professional training for pharmacists. This would reduce investment costs and create economies of scale in innovation and production.

Last month's endorsement by AMCOST of the Strengthening Pharmaceutical Innovation in Africa initiative opens the way for joint action — between policymakers, pharmaceutical producers and development partners — to make country-driven pharmaceutical strategies a reality for Africa.

It marks the beginning of a real movement to create a new cadre of African research and innovation managers to take on the challenge of developing pharmaceutical innovation on the continent.

Ibrahim Assane Mayaki is chief executive officer of the New Partnership for Africa's Development (NEPAD).

Carel IJsselmuiden is director of the Council on Health Research for Development (COHRED).

Ibrahim Assane Mayaki and Carel IJsselmuiden

SciDev

First promising TB drug in decades, say researchers

Mycobacterium tuberculosis
Flickr/AJC1
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The first new tuberculosis drug in 40 years has successfully treated multidrug-resistant tuberculosis (MDR-TB) patients in a clinical trial in South Africa.
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Diarylquinoline TMC207 works differently from other anti-tuberculosis drugs by targeting an enzyme of Mycobacterium tuberculosis, the agent that causes TB.
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"This is an exciting new development and the first new TB drug in over forty years," says Alexander Pym, one of the researchers and a chief specialist scientist at the South African Medical Research Council's Clinical and Biomedical TB Research Unit based in Durban, South Africa.
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The researchers gave the drug to 20 patients in addition to standard therapy for MDR-TB for eight weeks.
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Twenty-one patients received a placebo plus standard treatment.
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About half the patients on TMC207 were successfully treated compared to about ten per cent on the placebo. The patients are being monitored to see if treatment remains effective.
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TMC207 was discovered using an old method of drug discovery that has not been used in the last 40 years.
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Modern approaches use computer software to identify drug targets and then design the desired drug, while this approach tests compounds on a rapidly growing relative of M. tuberculosis.
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"What we saw over the eight weeks was a significant difference in the rate in which tuberculosis disappeared," Andreas Diacon, one of the researchers, and the director of the Centre of Clinical Tuberculosis Research at the University of Stellenbosch, told SciDev.Net.
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The drug works on both drug-susceptible and drug-resistant TB in the laboratory and the implications are that this new drug might shorten treatment time for all tuberculosis patients, says Diacon.
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MDR-TB patients take five drugs for up to 18 months and patients with standard tuberculosis take four drugs for six months.
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Diacon adds that because this is a new drug with a new way of working patients will not have developed a resistance — potentially increasing the proportion of people who could be cured.
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A second group of MDR-TB patients is now undergoing a longer, six-month trial of TCM207 in South Africa.
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The research was published in the New England Journal of Medicine this month (4 June).
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Sharon Davis
CAPE TOWN
SciDev
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full abstract

http://content.nejm.org/cgi/content/full/360/23/2397

Promising microbicide can be produced by plants

Fields of genetically modified tobacco could produce large quantities of microbicide
Flickr/perrykm5
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Scientists have developed an anti-HIV microbicide that can be mass-produced in plants — in quantities large enough to make it affordable for people in developing countries, they say.
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The microbicide, which has been found to prevent HIV transmission in cells, is a combination of two promising microbicide compounds — monoclonal antibody b12 and the protein cyanovirin-N.
Together the compounds are "more potent at neutralising HIV than its single components", Amy Sexton, lead author of the study and a researcher at the University of Melbourne, Australia, told SciDev.Net.
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The researchers also showed that the microbicide can be mass-produced by transferring the gene constructed for the microbicide into tobacco plant cells.
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"This way the plant expresses the gene and produces the microbicide in the same way it produces its own proteins," says Sexton.
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Scaling-up production simply requires growing acres of the plants from genetically modified seeds, she adds.
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Microbicide gels and creams are a great hope for female-initiated protection from HIV/AIDS but so far trials have had mixed results
(see Drugs may be the next frontier for HIV prevention and
Anti-HIV gel fails to prevent infection).
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In February this year, research suggested that the anti-HIV gel PRO 2000 might protect against infection
(see Microbicide hope at last, say researchers)
but the results were not completely certain.
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The results of a larger PRO 2000 study are due in December 2009.
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"The success of microbicides depends not only on the identification of a broad-acting effective product, but also on the issue of cheap and easy production at a huge scale for global availability.
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We have demonstrated the potential for overcoming both of these hurdles," says Sexton.
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But Morad Ahmed Morad, a professor of medicine at Tanta University, Egypt, is more cautious, saying that potential health issues such as allergic reaction to a plant-produced microbicidal cream and environmental concerns about the spread of the inserted gene to other plants need to be considered.
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He adds that developing countries may not be able to produce such a microbicide themselves because its production will be controlled by patents.
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The research was published online in The FASEB Journal.

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Link to abstract in The FASEB Journal

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Wagdy Sawahel
SciDev