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AstraZeneca enters late-stage COVID-19 vaccine trial

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Aug. 31 (UPI) — Multinational pharmaceutical company AstraZeneca announced it has started Phase III clinical trials in the United States of its COVID-19 candidate vaccine as the World Health Organization warned against prematurely approving drugs to fight the pandemic.

The company said in a statement Monday that it will enroll up to 30,000 adults in the United States to assess the safety, efficacy and immunogenicity of its candidate coronavirus prevention drug, AZD1222, which it co-invented with Britain’s Oxford University.

The U.S. trial centers are recruiting the tens of thousands of participants “from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from SARS-CoV-2 virus,” AstraZeneca said, referring to COVID-19 by its technical name.

Participates in the trial will receive two doses of either the candidate vaccine or a placebo saline control separated by four weeks and while all will be assessed for the drug’s safety and efficacy a subset of 3,000 volunteers will be checked for local and systemic reactions and immune responses, it said.

The company is also continuing with late-stage clinical trials in Britain, Brazil and South Africa with further trials planned to begin for Japan and Russia.

“These trials, together with the U.S. Phase III clinical trial, will enroll up to 50,000 participants globally,” the press release said.

Results from the late-stage trial are expected later this year.

The announcement came as the World Health Organization’s Dr. Soumya Swaminathan warned that authorizing a vaccine prematurely could hamper research and introduce a drug to the public that doesn’t work.

“What is going to be really important, I think, is to make decisions based on science, and have a scientific group that’s constituted, that’s above all conflicts of interests, that’s not influenced by any interests, that looks at the data and makes a recommendation on whether and when a vaccine should be licensed for use,” she said Monday during a WHO briefing on the coronavirus.

The risks of releasing an understudied vaccine, she said, are not only limited to producing a drug that doesn’t protect against COVID-19 but that it could be unsafe.

AstraZeneca released a second statement on Monday reiterating its core values as to “follow the science” and “put patients first.”

“At the heart of AstraZeneca’s core values is to ‘follow the science’ and adhere to the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance,” it said. “The company’s submissions for market authorization will meet the stringent requirements established by regulators everywhere around the world.”

At least two other companies — Moderna and Pfizer/BioNtech — have vaccine candidates in late state trials.



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Healthy diet, exercise good for heart regardless of medication use

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No matter how many medications you take, eating a healthy diet, not smoking and getting plenty of exercise will help keep you alive, a new study finds.

“We’ve long known about the benefits of leading a healthy lifestyle. The results from our study underscore the importance of each person’s ability to improve their health through lifestyle changes even if they are dealing with multiple health issues and taking multiple prescription medications,” said researcher Neil Kelly. He’s a medical student at Weill Cornell Medicine of Cornell University in New York City.

For the study, Kelly’s team collected data on more than 20,000 people who took part in a study on racial differences in stroke.

At the start of the study, 44% of participants were taking four or fewer prescription medications, 39% were taking five to nine, and 17% were taking 10 or more medications.

After about 10 years, the researchers found that a healthy lifestyle reduced the risk of death during the study period regardless of the number of medications a person was taking, and the more healthy lifestyle habits one had, the lower the risk of death.

The findings were scheduled for presentation at the American Heart Association’s virtual annual meeting, Nov. 13 to 17. Such research should be considered preliminary until published in a peer-reviewed journal.

“It’s especially important for health care professionals to counsel patients and develop interventions that can maximize healthy lifestyle behaviors, even among patients with several prescription medications,” Kelly said in an AHA news release.

“It’s important for the public to understand that there is never a bad time to adopt healthy behaviors. These can range from eating a healthier diet to taking a daily walk in their neighborhood,” he added. “A healthier lifestyle buys more time.”

More information

For more on a healthy lifestyle, head to the American Heart Association.

Copyright 2020 HealthDay. All rights reserved.



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Bacteria in lungs may play role in cancer development, study says

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Lung cancer patients who harbor certain bacteria in the airways may have a poorer prognosis, a new study finds, adding to evidence that the body’s “microbiome” may play a role in cancer patients’ outlook.

The microbiome refers to the trillions of bacteria and other microbes that naturally dwell in the body. Research in recent years has been revealing how important those bugs are to the body’s normal functions, including immune system defenses.

When it comes to cancer, studies have hinted that the microbiome can influence tumor progression, and patients’ likelihood of responding to certain treatments.

For example, a number of cancers can be treated with immunotherapy — various approaches to boosting the immune system’s natural tumor-fighting capacity. Research has found that patients who respond well to immunotherapies tend to have a different makeup in the gut microbiome, compared to patients who do not respond.

The new study, published this week in Cancer Discovery, took a different view. Instead of focusing on the gut microbiome, researchers analyzed lung microbes of patients with newly diagnosed lung cancer.

In microbiome research, “the lung has really been ignored,” said lead researcher Dr. Leopoldo Segal, director of the Lung Microbiome Program and an associate professor at New York University Grossman School of Medicine in New York City.

Traditionally, he explained, the lungs were believed to be “sterile.” But recent research has shown that even in healthy people, the lungs can harbor low amounts of bacteria — drawn in from the air or the mouth.

Segal’s team wanted to see whether lung bacteria corresponded to lung cancer patients’ prognosis.

Looking at tissue samples from 83 patients, the researchers found that those with advanced-stage cancer carried more microbes than patients in the early stage of disease.

And when patients did have “enrichment” with certain bacteria types, their odds of survival were lower — even those with earlier-stage cancer.

Specifically, patients harboring Veillonella, Prevotella and Streptococcus bacteria had a worse prognosis. They also showed signs of an inflammatory immune response that, based on past research, may worsen lung cancer patients’ outlook.

None of that proves the bacteria, themselves, were to blame, Segal said. The cancer itself might make the lungs more “receptive” to being colonized with bacteria.

So the researchers turned to lab mice. They transferred Veillonella bacteria into mice with lung cancer and found that the microbes revved up “bad” inflammation, fed tumor growth and shortened the animals’ survival.

That suggests lung bacteria might modulate the immune response in a way that affects lung cancer progression, according to Segal.

But the microbiome is complicated, and it’s hard to draw conclusions from mouse findings, according to Dr. Thomas Marron of Mount Sinai’s Tisch Cancer Institute in New York City.

Right now, he said, there is a “huge interest” in understanding the microbiome’s influence in cancer.

“Studies like this are really interesting,” said Marron, who was not involved with the research, “but we’re probably a few decades away from being able to alter the microbiome to treat cancer.”

Individuals vary in their microbiome makeup, and that’s determined by things like genetics and the immune system, Marron explained. So even if the body’s microbial communities directly affect cancer prognosis, he said, it will be a long time before researchers can turn that into therapy.

“We still don’t know how we could effectively target the microbiome,” Marron said.

He pointed to one question from the new findings: Is there any link between the lung microbiome and patients’ likelihood of responding to immunotherapy?

Segal said his team plans to study that.

Dr. John Heymach chairs thoracic/head and neck medical oncology at M.D. Anderson Cancer Center in Houston. He called the findings “a compelling starting point,” but also emphasized the long research road ahead.

“At this point, we’re not ready to directly act on this in the clinic, by either trying to kill ‘bad’ bacteria, or add back ‘good’ bacteria,” said Heymach, who was not part of the study.

So far, he noted, studies have reached different conclusions as to exactly which types of bacteria are related to better cancer outcomes — which might be due to differences in how studies look for the microbes.

And like Marron, Heymach pointed to the microbiome’s complexity: It generally differs from one large population to the next and among individuals — based on numerous factors.

Still, Heymach said the recent “explosion” in microbiome research could eventually lead to applications in cancer treatment. Besides the possibility of altering the microbiome, he said doctors might be able to use patients’ microbiome makeup as a “biomarker” of their risk of progression.

More information

The American Cancer Society has more on cancer immunotherapy.

Copyright 2020 HealthDay. All rights reserved.



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Study: More than 4 million potential years of life lost to cancer in the U.S.

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Nov. 13 (UPI) — Deaths from cancer accounted for more than 4 million potential years of life lost in 2017 in the United States, striking down young adults in particular well before average life expectancy, an analysis published Friday by the journal Cancer Epidemiology, Biomarkers & Prevention found.

There were 599,099 cancer deaths nationally in 2017, based on death certificate data from the National Center for Health Statistics.

Lung cancer, the most deadly cancer in the United States, accounted for approximately 24% of cancer deaths nationally and 21% of potential years of life lost, while colon and rectal cancer made up 9% of deaths and 10% of potential years of life lost, the data showed.

In addition, pancreatic cancer was the cause of just over 7% of cancer deaths nationally and 7% of potential years of life lost and breast cancer accounted for 7% of deaths and 9% of potential years of life lost.

“Potential years of life lost is a useful complementary measure to cancer mortality rates,” study co-author Dr. Minkyo Song said in a statement.

“Together, they provide a more detailed picture of the social and economic toll of cancer,” said Song, a research fellow at the National Cancer institute, part of the National Institutes of Health.

More than 600,000 people in the United States have died or will die from cancer in 2020, according to the National Cancer Institute.

Potential years of life lost is an estimate of the average years a person would have lived if he or she had not died prematurely.

Average life expectancy in the United States is about 79 years, and cancer is the leading cause of death in those younger than 80 years.

For this study, the researchers used national mortality data from the U.S. National Center for Health Statistics, and defined potential years of life lost as the number of years lost prior to age 75 to quantify how many years of life were prematurely lost.

Nearly 4.3 million years of life were prematurely lost due to cancer in 2017, the data showed.

Ethnic and racial minority groups account for a disproportionate share of the burden of premature cancer death in 2017, with 78% occurring in non-Hispanic Whites with only 70% of potential years of life lost.

Conversely, Hispanic people accounted for 7% of cancer deaths and 10% of potential years of life lost, while Black people made up 12% of cancer deaths and 15% of potential years of life lost, the data showed.

Testicular cancer had the highest potential years of life lost per death, with an average of 34 years lost, followed by bone cancer, with an average of 26 years lost and endocrine cancers including thymus cancer, with an average of 25 years lost, the researchers said.

The total number of potential years of life lost increased slightly from 1990, despite an overall decrease in cancer deaths, researchers said.

In 1990, 4.26 million potential years of life were lost, compared with the 4.28 million in 2017, the data showed, with the increase likely due to the growth of the U.S. population.

For the most part, potential years of life lost mirrored overall U.S. cancer mortality trends, but one exception to this pattern was prostate cancer — which caused about 5% of U.S. cancer deaths in 2017 but only 2% of potential years of life lost.

“Potential years of life lost can be used to estimate the impact of cancer death in younger populations,” Song said. “This metric highlights the enormous loss of life due to certain cancers that occur at younger ages, even if they occur infrequently.”



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