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Japanese Flu Drug Favipiravir 'Clearly Effective' In Treating Coronavirus, Claims China
Thursday, 19 March 2020
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Japanese media said that Zhang Xinmin has claimed that favipiravir, developed by a subsidiary of Fujifilm, had produced good encouraging outcomes in clinical trials conducted on 340 patients in Wuhan and Shenzhen, reported Guardian.
An official at China's Science and Technology Ministry said on Wednesaday that a Japanese flu drug to treat new strains of influenza has proved 'clearly effective' in treating coronavirus patients.
Japanese media said that Zhang Xinmin has claimed that favipiravir, developed by a subsidiary of Fujifilm, had produced good encouraging outcomes in clinical trials conducted on 340 patients in Wuhan and Shenzhen, reported Guardian.
“It has a high degree of safety and is clearly effective in treatment,” Zhang told reporters.
Japanese public broadcaster NHK reported that patients who were given the medicine in Shenzhen turned negative for the virus nearly four days after testing postive for the virus.
The X-rays of these patients also showed improvements in lung condition in about 91% of the patients, while it was 62% on those without the drug.
The drug which is also known as Avigan is developed by uFujifilm Toyama Chemical. The pharma company has preferred not to comment on this matter.
Guardian reported that Avigan is being used by Japanese doctors in clinical studies on coronavirus patients with mild to moderate symptoms.
A Japanese health ministry source, however, said that 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.
Notably, favipiravir was used by the Japanese government in 2016 as an emergency aid to counter the Ebola virus outbreak in Guinea.
It is learnt that Favipiravir would need approval from Japanese government for full-scale use on Covid-19 patients and the drug could be approved as early as May. “But if the results of clinical research are delayed, approval could also be delayed.”
TRUTH
Cuba’s Contribution To Combatting COVID-19
by HELEN YAFFE-MARCH 17, 2020
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Photograph Source: NatalieMaynor – CC BY 2.0
COVID-19 surged in the Chinese city of Wuhan in late December 2019 and by January 2020 it had hit Hubei province like a tidal wave, swirling over China and rippling out overseas. The Chinese state rolled into action to combat the spread and care for those infected. Among the 30 medicines the Chinese National Health Commission selected to fight the virus was a Cuban anti-viral drug Interferon Alpha 2b. This drug has been produced in China since 2003, by the enterprise ChangHeber, a Cuban-Chinese joint venture.
Cuban Interferon Alpha 2b has proven effective for viruses with characteristics similar to those of COVID-19. Cuban biotech specialist, Dr Luis Herrera Martinez explained that ‘its use prevents aggravation and complications in patients, reaching that stage that ultimately can result in death.’ Cuba first developed and used interferons to arrest a deadly outbreak of the dengue virus in 1981, and the experience catalysed the development of the island’s now world-leading biotech industry.
The world’s first biotechnology enterprise, Genetech, was founded in San Francisco in 1976, followed by AMGen in Los Angeles in 1980. One year later, the Biological Front, a professional interdisciplinary forum, was set up to develop the industry in Cuba. While most developing countries had little access to the new technologies (recombinant DNA, human gene therapy, biosafety), Cuban biotechnology expanded and took on an increasingly strategic role in both the public health sector and the national economic development plan.
It did so despite the US blockade obstructing access to technologies, equipment, materials, finance and even knowledge exchange. Driven by public health demand, it has been characterised by the fast track from research and innovation to trials and application, as the story of Cuban interferon shows.
Interferons are ‘signalling’ proteins produced and released by cells in response to infections which alert nearby cells to heighten their anti-viral defences. They were first identified in 1957 by Jean Lindenmann and Aleck Isaacs in London. In the 1960s Ion Gresser, a US-researcher in Paris, showed that interferons stimulate lymphocytes that attack tumours in mice. In 1970s, US oncologist Randolph Clark Lee, took up this research.
Catching the tail end of US President Carter’s improved relations with Cuba, Dr Clark Lee visited Cuba, met with Fidel Castro and convinced him that interferon was the wonder drug. Shortly afterwards, a Cuban doctor and a haematologist spent time in Dr Clark Lee’s laboratory, returning with the latest research about interferon and more contacts. In March 1981, six Cubans spent 12 days in Finland with the Finnish doctor Kari Cantell, who in the 1970s had isolated interferon from human cells, and had shared the breakthrough by declining to patent the procedure. The Cubans learned to produce large quantities of interferon.
Within 45 days of returning to the island, they had produced their first Cuban batch of interferon, the quality of which was confirmed by Cantell’s laboratory in Finland. Just in time, it turned out. Weeks later Cuba was struck by an epidemic of dengue, a disease transmitted by mosquitos. It was the first time this particularly virulent strand, which can trigger life-threatening dengue haemorrhagic fever, had appeared in the Americas.
The epidemic affected 340,000 Cubans with 11,000 new cases diagnosed every day at its peak. 180 people died, including 101 children. The Cubans suspected the CIA of releasing the virus. The US State Department denied it, although a recent Cuban investigation claims to provide evidence that the epidemic was introduced from the US.
Cuba’s Ministry of Public Health authorised the use of Cuban interferon to halt the dengue outbreak. It was done at great speed. Mortality declined. In their historical account, Cuban medical scientists Caballero Torres and Lopez Matilla wrote: ‘It was the most extensive prevention and therapy event with interferon carried out in the world. Cuba began to hold regular symposia, which quickly drew international attention’. The first international event in 1983 was prestigious; Cantell gave the keynote speech and Clark attended with Albert Bruce Sabin, the Polish American scientist who developed the oral polio vaccine.
Convinced about the contribution and strategic importance of innovative medical science, the Cuban government set up the Biological Front in 1981 to develop the sector. Cuban scientists went abroad to study, many in western countries. Their research took on more innovative paths, as they experimented with cloning interferon.
By the time Cantell returned to Cuba in 1986, the Cubans had developed the recombinant human Interferon Alfa 2b which has benefited thousands of Cubans since then. With significant state investment, Cuba’s showpiece Centre for Genetic Engineering and Biotechnology (CIGB) was opened in 1986. By then Cuba was submerged in another health crisis, a serious outbreak of Meningitis B, which further spurred Cuba’s biotechnology sector.
Cuba’s Meningitis Miracle
In 1976, Cuba was struck by meningitis B and C outbreaks. Since 1916 only a few isolated cases had been seen on the island. Internationally, vaccines existed for Meningitis A and C, but not for B. Cuban health authorities secured a vaccine from a French pharmaceutical company to immunise the population against type C Meningitis. However, in the following years, cases of type B Meningitis began to rise. A team of specialists from different medical science centres was established, led by a woman biochemist, Concepción Campa, to work intensively on finding a vaccine.
By 1984 Meningitis B had become the main health problem in Cuba. After six years of intense work, Campa’s team produced the world’s first successful Meningitis B vaccine in 1988. A member of Campa’s team, Dr Gustavo Sierra recalled their joy: ‘this was the moment when we could say it works, and it works in the worst conditions, under pressure of an epidemic and among people of the most vulnerable age.’ During 1989 and 1990, three million Cubans, those most at risk, were vaccinated.
Subsequently, 250,000 young people were vaccinated with the VA-MENGOC-BC vaccine, a combined Meningitis B and C vaccination. It recorded 95% efficacy overall, with 97% in the high-risk three months to six years age group. Cuba’s Meningitis B vaccine was awarded a UN Gold Medal for global innovation. This was Cuba’s meningitis miracle.
‘I tell colleagues that one can work 30 years, 14 hours a day just to enjoy that graph for 10 minutes,’ Agustin Lage, Director of the Centro for Molecular Immunology (CIM) told me, referring to an illustration of the rise and sudden fall of Meningitis B cases in Cuba. ‘Biotechnology started for this. But then the possibilities of developing an export industry opened up, and today, Cuban biotechnology exports to 50 countries.’
Since its first application to combat dengue fever, Cuba’s interferon has shown its efficacy and safety in the therapy of viral diseases including Hepatitis B and C, shingles, HIV-AIDS and dengue. Because it interferes with viral multiplication within cells, it has also been used in the treatment of different types of carcinomas. Time will tell if Interferon Alfa 2b proves to be the wonder drug as far as COVID-19 goes.
TRUTH
COVID-19: Could Hydroxychloroquine Really Be the Answer?
By Aude Lecrubier-March 18, 2020
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Could the old generic malaria drug hydroxychloroquine (Plaquenil, Sanofi-Aventis, among others), which is also used for the treatment of rheumatic disease, be an essential treatment for COVID-19?
This hypothesis, put forward by some, including Professor Didier Raoult of the IHU Méditerranée Infection in Marseille, was dismissed by other eminent infectious disease specialists and dismissed as fake news recently by the Ministry of Health.
Yet it resurfaced yesterday with the presentation on YouTube by Prof Raoult of positive results in a non-randomised, unblinded trial of 24 patients.
This follows encouraging in vitro results obtained by a Chinese team led by Xueting Yao, from Peking University Third Hospital, Beijing, China, which were published online by the journal Clinical Infectious Diseases on March 9th. However, the data were deemed insufficient by the infection community to recommend the compound as a treatment.
Moreover, chloroquine is not listed among the four treatments studied as part of the recently launched European clinical trial piloted by Inserm, which includes 3200 severe hospitalised patients, including 800 French patients.
Chloroquine was ruled out due to the risk of interactions with other medications for common comorbidities in infected patients, and because of possible adverse effects in patients undergoing resuscitation.
The Marseille Study
The European Union Clinical Trials Register shows that the Marseille study was accepted on 5th March by the National Medicines Safety Agency (ANSM). It could include up to 25 COVID-19 positive patients, comprising five aged 12–17 years, 10 aged 18–64 years, and 10 more aged 65 years or over.
While the data have not yet been published, and should therefore be interpreted with caution, this non-randomised, unblinded study showed a strong reduction in viral load with hydroxychloroquine.
After 6 days, the percentage of patients testing positive for COVID-19 who received hydroxychloroquine fell to 25% versus 90% for those who did not receive the treatment (a group of untreated COVID-19 patients from Nice and Avignon).
In addition, comparing untreated patients, those receiving hydroxychloroquine and those given hydroxychloroquine plus the antibiotic azithromycin, the results showed there was "a spectacular reduction in the number of positive cases" with the combination therapy, said Prof Raoult.
At 6 days, among patients given combination therapy, the percentage of cases still carrying SRAS-CoV-2 was no more than 5%.
Azithromycin was added because it is known to be effective against complications from bacterial lung disease but also because it has been shown to be effective in the laboratory against a large number of viruses, the infectious disease specialist explained.
"Everyone who died from COVID-19 were still carriers of coronavirus. To no longer have the virus changes the prognosis," Prof Raoult said.
More detailed results of the study have been submitted for publication in the International Journal of Antimicrobial Agents.
Study Splits Infectious Disease Community
The announcement of positive results from this small study split medical opinion.
Professor Gilles Pialoux, an infectious disease specialist at Tenon Hospital, was cautious in his response. He told Medscape's French Edition: "The idea is interesting but we need large, randomised, controlled trials. We should not communicate this kind of information on YouTube, it is not meaningful.
"Don’t forget, this compound has not been included in Inserm’s trial because there are more interesting avenues, such as remdesivir or Kaletra [lopinavir/ritonavir]. We must be careful not to repeat the story with cyclosporin in HIV."
Christian Perronne, head of infectious diseases, University Hospital Raymond Poincaré, Garches, Paris, was more enthusiastic.
"I really believe in hydroxychloroquine. It is a drug I find rather fascinating, that has been used for decades. There have been positive results in an in vitro study and a preliminary Chinese study in 100 patients which showed that hydroxychloroquine reduced the viral load, the symptoms lasted for less time, and they are not as severe. This could reduce the number of carriers, which I find interesting from an epidemiological perspective.
"I think from an ethical point of view, we should suggest it to all patients with severe disease who are hospitalised, under surveillance and on short treatment, paying attention to drug interactions, especially with drugs that prolong the QT interval. Afterwards, in terms of adverse effects, at increased doses, it is possible that patients will have pain or fever, but it seems that the treatment is effective at lower doses, according to the Chinese data. In any case, the adverse effects of this compound are not dangerous."
On the adverse effects, Professor Thomas Papo, from Bichat Hospital, the University of Paris, confirmed via email: "Hydroxychloroquine (Plaquenil, which is not chloroquine), vaunted by Didier Raoult as an anti-viral, has been used for decades in tens of thousands of patients, for several decades, so we have a huge follow-up and lots of data. This drug is remarkably well tolerated and we give it to all patients with lupus (for example), including in pregnant women. The main complication (retinal toxicity) is rare and does not last beyond 5 years of continuous use."
Hydroxychloroquine Tested in Other Hospitals
At the end of Tuesday’s Council of Ministers, Sibeth Ndiaye, a government spokesperson, discussed the results published by Prof Raoult. "The clinical trial in Marseille is a promising start; we are extending it because science requires the experience to be validated and repeated several times to be able to say whether or not it works," she warned. Other tests will be carried out at Lille Hospital to confirm, or not, Prof Raoult’s results.
Chloroquine is currently being examined in a number of clinical studies in China and elsewhere, and some in France have also decided to suggest it following Prof Raoult’s findings.
This is the case for Dr Alexandre Bleibtreu, an internal medicine specialist at Pitié Salpêtrière Hospital, Paris, who was initially not persuaded by the in vitro data but has changed his opinion after having seen the results of the study carried out by Didier Raoult.
Contacted by CheckNews, the on-demand journalism service from Liberation, he explained that the compound was now used in almost all (approximately 50) hospitalised patients in their service, except those who refuse it or who have contraindications.
"I heard about the results, which changed my mind. We followed the Marseille protocol, and there are surely others who will use it. It is not the most obvious treatment; it works in vitro but we didn’t have data in vivo.
"The aim is not to be right but that our patients get better. No treatment is magic and the publication of the results raises questions but between doing nothing and repositioning drugs based on their adverse effects, interactions, etc, we try things as we go."
Scientific Rationale
In the UK, Robin May, Professor of Infectious Disease at the University of Birmingham, explained that there is a scientific rationale for the use of hydroxychloroquine in the treatment of COVID-19, based on its mode of action in malaria.
In a statement through the Science Media Centre, he explained that, as chloroquine is a "weak base" and so helps to neutralise acids, it makes the environment "less suitable" for the malaria parasite to live in when it diffuses into red blood cells.
While the mode of action against COVID-19 is not established, Prof May said, he pointed out that many viruses enter host cells via endocytosis, as a result of which they are initially taken up into an intracellular 'compartment that is "typically fairly acidic”.
"Chloroquine would alter the acidity of this compartment, which can interfere with the ability of viruses to escape into the host cell and start replicating.”
He continued: "Another possibility is that chloroquine may alter the ability of the virus to bind to the outside of a host cell in the first place,” adding that the drug "has subtle effects on a wide variety of immune cells…and it may be that one of these effects helps stimulate the body’s ability to fight off COVID-19.”
Crucially, the drug is also "cheap and relatively easy to manufacture" and so could easily be put into clinical trials and, eventually, treatment, May underlined.
The study by Yao et al was supported by the "13th Five-Year" National Major New Drug Projects of China, Ministry of Science and Technology of the People’s Republic of China, and Bill & Melinda Gates Foundation.
Two of its authors have patents pending for an anti-microbial infection pharmaceutical composition and its application.
Professor Pialoux has been a board member or attended meetings for Gilead, MSD, Bristol-Myers Squibb, Janssen, Abbvie, AstraZeneca.
Clin Infect Dis. 2020 Mar 9. pii: ciaa237. doi: 10.1093/cid/ciaa237
Translated and adapted from Medscape's French edition.
Editor's note, 18th March 2020: This article was updated to include Prof May's comments.
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