The Drugmaker Merck Says Its Antiviral Pill Is Effective Against Coronavirus

The drug maker says its pill was shown in a clinical trial to cut the risk of hospitalization or death from the virus in half. Australia is accelerating plans to ease international travel restrictions for its citizens and permanent residents.

The drug maker Merck said on Friday that it would seek authorization for the first antiviral pill for Covid after its drug, known as molnupiravir, was shown in a clinical trial to cut the risk of hospitalization or death in half when given to high-risk people early in their infections.

The treatment could become the first in a wave of antiviral pill products, which experts say could offer a powerful new tool in efforts to tame the pandemic, as they could reach more people than the antibody treatments that are being widely used in the United States for similar patients.

I think it will translate into many thousands of lives being saved worldwide, where there’s less access to monoclonal antibodies, and in this country, too,” said Dr. Robert Shafer, an infectious disease specialist and expert on antiviral therapy at Stanford University.

Late-stage study results of two other antiviral pills, one developed by Pfizer and the other by Atea Pharmaceuticals and Roche, are expected within the next few months.

The Merck drug, which is designed to stop the coronavirus from replicating, is to be taken as four capsules twice a day for five days.

Merck said an independent board of experts monitoring its study data had recommended that its trial be stopped early because the drug’s benefit to patients had proved so convincing. The company said that the Food and Drug Administration had agreed with that decision.

For the research, the monitors looked at data through early August, when the study had enrolled 775 volunteers in the United States and overseas. For volunteers who received the drug, their risk of being hospitalized or dying fell 50 percent, without any concerning side effects, compared with those who received placebo pills, Merck said in a news release announcing the findings.

Seven percent of volunteers in the group that received the drug were hospitalized, and none of them died, compared with a 14 percent rate of hospitalization and death — including eight deaths — in the group that received the placebo.

The Merck pill’s efficacy was lower than that of monoclonal antibody treatments, which mimic antibodies that the immune system generates naturally when fighting the virus. Those drugs have been in high demand recently, but they are expensive, are typically given intravenously, and have proved cumbersome and labor-intensive for hospitals and clinics to administer. Studies have shown that they reduce hospitalizations and deaths 70 to 85 percent in similar high-risk Covid patients.

Source: https://www.nytimes.com/

World’s First COVID-19 DNA Vaccine

 India‘s drug regulator has granted emergency use approval for Zydus Cadila‘s COVID-19 vaccine, the world’s first DNA shot against the coronavirus, in adults and children aged 12 years and above. The approval gives a boost to India’s vaccination programme, which aims to inoculate all eligible adults by December, and will provide the first shot for those under 18, as the country still struggles to contain the virus spread in some states. The vaccine, ZyCoV-D, uses a section of genetic material from the virus that gives instructions as either DNA or RNA to make the specific protein that the immune system recognises and responds to. Unlike most COVID-19 vaccines, which need two doses or even a single dose, ZyCoV-D is administered in three doses.

The generic drugmaker, listed as Cadila Healthcare Ltd, aims to make 100 million to 120 million doses of ZyCoV-D annually and has already begun stockpiling the vaccineZydus Cadila‘s vaccine, developed in partnership with the Department of Biotechnology, is the second home-grown shot to get emergency authorization in India after Bharat Biotech‘s Covaxin. The drugmaker said in July its COVID-19 vaccine was effective against the new coronavirus mutants, especially the Delta variant, and that the shot is administered using a needle-free applicator as opposed to traditional syringes. The regulatory nod makes ZyCoV-D the sixth vaccine authorized for use in the country where only about 9.18% of the entire population has been fully vaccinated so far, according to Johns Hopkins data.

The firm had applied for the authorization of ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of over 28,000 volunteers nationwide.

https://www.reuters.com/

How to Use mRNA Technology in Vaccines to Fight Cancer

Until recently, most of the world had never heard of mRNA vaccines. To combat COVID-19, the United States Food and Drug Administration issued emergency use authorization in December 2020 for mRNA vaccines developed by Pfizer-BioNTech and Moderna. While the pandemic brought mRNA vaccines into the limelight, melanoma patient Bobby Fentress had experience with mRNA technology nearly a year prior. mRNA vaccines hold promise for fighting infectious diseases beyond the SARS-CoV-2 virus, including fighting cancer. At age 68, Bobby was an early participant in a clinical trial intended to see whether a vaccine made with mRNA could destroy his cancer cells and prevent recurrence.

Bobby’s story began in 2019. He found an odd bump on his middle finger and assumed it was a wart. After his wife urged him to be seen by a dermatologist, he received a call that he would need a biopsy – which ultimately revealed that he had stage 2c melanoma. Several months later, Bobby had most of his middle finger amputated and was told that there was a 50% possibility that the cancer would reoccur.  That’s when Bobby decided to enroll in a clinical trial with HCA Healthcare’s Sarah Cannon Research Institute in Nashville, Tennessee. He received his first shots of a personalized mRNA vaccine created by Moderna in April 2020. These vaccines are developed from a patient’s specific tumor DNA. The DNA of the tumor is analyzed to determine the differences between the tumor and a patient’s own cells and which proteins might elicit the best immune response. The mRNA vaccine is then developed to instruct the body to make these proteins and stimulate an immune response. Patients such as Bobby then receive a series of these vaccine treatments.

Bobby finished his year of treatment earlier this spring. While it is too early to know if the therapy will work, Bobby’s oncologist, Dr. Meredith McKean, is optimistic.  Immunotherapy has been a game changer for melanoma. With mRNA, the hope is that personalized therapy would offer additional treatment benefit above our standard treatments that we offer for patients broadly. Even for patients like Bobby that had surgery, ten years ago we wouldn’t be able to give him anything but highly toxic therapy options. It’s refreshing to offer a clinical trial like this. While the trial is not yet complete, we have enough data to be hopeful. It’s a very encouraging area that I’m excited about as a provider,” says Dr McKean, associate director of the melanoma and skin cancer research program at Sarah Cannon Research Institute.

https://hcahealthcaretoday.com/

New Disinfectant Protects Against Covid for Up 7 Days

An alum and several researchers at the University of Central Florida (UCF) have used nanotechnology to develop the cleaning agent, which protects against seven viruses for up to seven days.

UCF researchers have developed a nanoparticle-based disinfectant that can continuously kill viruses on a surface for up to seven days – a discovery that could be a powerful weapon against COVID-19 and other emerging pathogenic viruses. The findings, by a multidisciplinary team of the university’s virus and engineering experts and the leader of an Orlando technology firm, were published this week in  ACS Nano, a journal of the American Chemical Society.

Christina Drake ’07PhD, founder of Kismet Technologies, was inspired to develop the disinfectant after making a trip to the grocery store in the early days of the pandemic. There she saw a worker spraying disinfectant on a refrigerator handle, then wiping off the spray immediately.

Initially my thought was to develop a fast-acting disinfectant,” she says, “but we spoke to consumers, such as doctors and dentists, to find out what they really wanted from a disinfectant. What mattered the most to them was something long-lasting that would continue to disinfect high-touch areas like doorhandles and floors long after application.”

Drake partnered with Sudipta Seal, a UCF materials engineer and nanoscience expert, and Griff Parks, a College of Medicine virologist who is also associate dean of research and director of the Burnett School of Biomedical Sciences. With funding from the U.S. National Science Foundation, Kismet Tech and the Florida High Tech Corridor, the researchers created a nanoparticle-engineered disinfectant.

Its active ingredient is an engineered nanostructure called cerium oxide, which is known for its regenerative antioxidant properties. The cerium oxide nanoparticles are modified with small amounts of silver to make them more potent against pathogens.

It works both chemically and mechanically,” says Seal, who has been studying nanotechnology for more than 20 years. “The nanoparticles emit electrons that oxidize the virus, rendering it inactive. Mechanically, they also attach themselves to the virus and rupture the surface, almost like popping a balloon.”

Most disinfecting wipes or sprays will disinfect a surface within three to six minutes of application but have no residual effects. This means surfaces need to be wiped down repeatedly to stay clean from a number of viruses, like COVID-19. The nanoparticle formulation maintains its ability to inactivate microbes and continues to disinfect a surface for up to seven days after a single application.

The disinfectant has shown tremendous antiviral activity against seven different viruses,” says Parks, whose lab was responsible for testing the formulation against “a dictionary” of viruses. “Not only did it show antiviral properties toward coronavirus and rhinovirus, but it also proved effective against a wide range of other viruses with different structures and complexities. We are hopeful that with this amazing range of killing capacity, this disinfectant will also be a highly effective tool against other new emerging viruses.

The scientists are confident the solution will have a major impact in health care settings in particular, reducing the rate of hospital acquired infections, such as Methicillin-resistant Staphylococcus Aureus (MRSA), Pseudomonas aeruginosa and Clostridium difficile – which affect more than one in 30 patients admitted to U.S. hospitals. And unlike many commercial disinfectants, the formulation has no harmful chemicals, which indicates it will be safe to use on any surface. Regulatory testing for irritancy on skin and eye cells, as required by the U.S. Environmental Protection Agency, showed no harmful effects.

Many household disinfectants currently available contain chemicals that can be harmful to the body with repeated exposure,” Drake says. “Our nanoparticle-based product will have a high safety rating will play a major role in reducing overall chemical exposure for humans.”

Source: https://www.ucf.edu/

How To Reverse Cell Aging

A team of scientists has found why elderly people are more susceptible to COVID-19 and are working to reverse the aging process of the body’s immune system.

Scientists from the Technion-Israel Institute of Technology say they have found a way to rejuvenate the aging process of the body’s immune system. Prof. Doron Melamed and doctoral student Reem Dowery sought to understand why the elderly population is more susceptible to severe cases of COVID-19 and why the vaccines seem to be less effective and wane faster among this population. The results of their work were published this month in the peer-reviewed, online medical journal Blood.
The secret begins with B cells, also known as B lymphocytes. These are the cells that produce antibodies against any pathogen that enters the body. They play a key role in protecting people from viruses and diseases.
B cells do not just disappear. They turn into “memoryB cells so that if the body is exposed to a previous pathogen, the individual will not get sick. That is because the immune response will be fast and robust, and it will eliminate the pathogen, often without the individual knowing he or she had been exposed to it.


Imagine you are growing into adulthood, and you become an adult and then an older person,” Melamed said. “You accumulate in your body many memory cells. You are exposed all the time to pathogens, and hence you make more and more memory cells. Because these are so long-lived, there is no room left for new B cells.
What happens when a new pathogen, such as the coronavirus, comes along? There are no young B cells that can recognize it. That is one of the reasons why older people are more susceptible to severe COVID-19 and many other diseases. As noted, this happens because of the body’s need for homeostasis, something that Melamed’s lab discovered a decade ago. But this year, they took the discovery another step and figured out a mechanism to override the system.
We found specific hormonal signals produced by the old B cells, the memory cells, that inhibit the bone marrow from producing new B cells,” Melamed said. “This is a huge discovery. It is like finding a needle in a haystack.”

It also means that, over time, specific drugs or treatments can be found to inhibit one of the hormones in the signaling pathway and get the bone marrow to produce new B cells.

Source: http://www.jpost.com/

mRNA Vaccines will Soon Prevent Cancer

In the early 1990s, mRNA technology emerged as an alternative to traditional vaccine development, building on research conducted by Wolff et al. involving direct gene transfer into mouse muscle in vivo. Initially, mRNA technology came with drawbacks as it caused severe inflammation upon administration, degraded quickly in the body and was difficult to move across the membrane into the cell. However, breakthroughs using nanotechnology overcame some of these challenges; scientists encased the RNA and used synthetic RNA that the body’s immune system recognizes.

Other major technological innovation and research investment has improved the delivery, translation and stability, enabling mRNA to become a promising tool for vaccine development. These breakthroughs have allowed further research and development of mRNA vaccines, particularly against viruses such as HIV and influenza. In 2020, when the COVID-19 pandemic hit, several human clinical trials were underway to test mRNA vaccines against influenza and HIV. As a result of the pandemic, research efforts, funding and facilities prioritized the development of mRNA vaccines for COVID-19. Combined efforts of global research teams working on COVID-19 mRNA vaccinations accelerated the field of research, improving the knowledge, understanding and methods of mRNA vaccine technology. This allowed the progression of mRNA vaccines for other diseases, such as cancer, and clinical trials for mRNA cancer vaccinations are now underway. The MD Anderson Cancer Center (TX, USA) is conducting a clinical trial to test whether mRNA technology can be used to prevent the recurrence of colorectal cancer.


A B cell displays antibodies specific to antigens on a colorectal cancer cell and signals killer T cells to destroy it.

People with colorectal cancer often undergo surgery to remove the cancerous tumor; however, cancer cells remain in the body and shed DNA into the bloodstream, which is known as circulating tumor DNA (ctDNA) and can cause further complications and metastasis. Van Morris and Scott Kopetz are leading the Phase II trial (NCT04486378) for a personalized mRNA cancer vaccine. People who have stage II or III colorectal cancer are given a blood test after their surgery to check for ctDNA. The patient’s tumor tissue is genetically profiled to identify mutations that fuel cancer growth. The tumor mutations are then ranked from the most to the least common to create a personalized mRNA vaccine for the patient. “We’re hopeful that with the personalized vaccine, we’re priming the immune system to go after the residual tumor cells, clear them out and cure the patient,” explains Morris.

Source: https://www.future-science.com/

The Drug Masitinib Effective in Treating COVID-19

A new University of Chicago study has found that the drug masitinib may be effective in treating COVID-19. The drug, which has undergone several clinical trials for human conditions but has not yet received approval to treat humans, inhibited the replication of SARS-CoV-2 in human cell cultures and in a mouse model, leading to much lower viral loads.

Researchers at UChicago’s Pritzker School of Molecular Engineering (PME), working with collaborators at Argonne National Laboratory and around the world, also found that the drug could be effective against many types of coronaviruses and picornaviruses. Because of the way it inhibits replication, it has also been shown to remain effective in the face of COVID-19 variants.

Inhibitors of the main protease of SARS-CoV-2, like masitinib, could be a new potential way to treat COVID patients, especially in early stages of the disease,” said Prof. Savas Tay, who led the research. “COVID-19 will likely be with us for many years, and novel coronaviruses will continue to arise. Finding existing drugs that have antiviral properties can be an essential part of treating these diseases.”

The results were published  in Science.

Source: https://pme.uchicago.edu/

3 Existing Drugs Fight Coronavirus with ‘almost 100%’ Success

Israeli scientists say they have identified three existing drugs that have good prospects as COVID-19 treatments, reporting that they illustrated high ability to fight the virus in lab tests.

They placed the substances with live SARS‑CoV‑2 and human cells in vitro. The results “showed that the drugs can protect cells from onslaught by the virus with close to 100 percent effectiveness, meaning that almost 100% of the cells lived despite being infected by the virus,” Prof. Isaiah Arkin, the Hebrew University biochemist behind the research, told The Times of Israel.

By contrast, in normal circumstances, around half the cells would have died after two days following contact with the virus.” He added there are strong indications that the drugs will be robust against changing variants.

Arkin, part of a Hebrew University center that specializes in repurposing existing drugs, said that he screened more than 3,000 medicines for suitability, in what he describes as a needle-in-a-haystack search. This approach can provide a fast track to find treatments as the drugs have already been tried and tested, and he hopes to work with a pharmaceutical company to quickly get the medicines he identified clinically tested for COVID-19.

We have the vaccine, but we shouldn’t rest on our laurels, and I would like to see these drugs become part of the arsenal that we use to fight the coronavirus,” he said. When confronting SARS‑CoV‑2, the drugs in question — darapladib, which currently treats atherosclerosis; the cancer drug Flumatinib; and an HIV medicine — don’t target the spike protein. Rather, they target one of two other proteins: the envelope protein and the 3a protein. These proteins — especially the envelope proteinhardly change between variants, and even between diseases from the coronavirus family. As such, drugs that target them are likely to remain effective in spite of mutations, Arkin said.

Source: https://www.timesofisrael.com/

Nearly All COVID Deaths in US Are Now among Unvaccinated

Nearly all COVID-19 deaths in the U.S. now are in people who weren’t vaccinated, a staggering demonstration of how effective the shots have been and an indication that deaths per day — now down to under 300 — could be practically zero if everyone eligible got the vaccine.

An Associated Press analysis of available government data from May shows that “breakthroughinfections in fully vaccinated people accounted for fewer than 1,200 of more than 853,000 COVID-19 hospitalizations. That’s about 0.1%. And only about 150 of the more than 18,000 COVID-19 deaths in May were in fully vaccinated people. That translates to about 0.8%, or five deaths per day on average.

The AP analyzed figures provided by the Centers for Disease Control and Prevention. The CDC itself has not estimated what percentage of hospitalizations and deaths are in fully vaccinated people, citing limitations in the data.

https://apnews.com/

New Treatment Against Covid-19

The Institut Pasteur de Lille (France) will implement the protocol to perform clinical tests of a promising treatment against Covid-19. An authorization from the National Agency for the Safety of Medicines and Health Products (ANSM) which nevertheless comes eight months after the announcement of the discovery of this molecule by the teams of researchers.

On September 29, the Institut Pasteur de Lille confirmed to 20 Minutes have found an effective molecule against Covid-19.

It remains to conduct a clinical trial to definitively validate the antiviral activity of this molecule”, then underlined a member of the research team. This molecule had already received marketing authorization from the ANSM under the name Clofoctol for a pathology other than Covid-19. It was therefore a question of “repositioning” it as a Covid-19 treatment since “the in vitro tests have shown the effectiveness of this molecule in inhibiting the replication of the virus”, assures the Institute.

The file presented by Pasteur was validated by the Committee for the Protection of Persons (CPP) and, on Thursday, it also received the approval of the ANSM.

The clinical trial to test this experimental treatment in the early management of Covid patients, double-blind against placebo” will be able to start, “all the logistics are ready”, continues at Pasteur Lille. This test will take place in Hauts-de-France, in five centers. To be able to be included in this clinical trial, it is necessary to have made “a recent positive test, to be more than 50 years old, to have at least one symptom and not to have been vaccinated”.

If the administration of the drug will be done in the different centers, the patients will not be hospitalized. The follow-up will be provided at home thanks to the collaboration of general practitioners.

Source: https://news.in-24.com/