Short bouts of stairclimbing throughout the day can boost health

A few minutes of stair climbing, at short intervals throughout the day, can improve cardiovascular health, according to new research from kinesiologists at McMaster University and UBC Okanagan.

The findings, published in the journal Applied Physiology, Nutrition and Metabolism, suggest that virtually anyone can improve their fitness, anywhere, any time.

“The findings make it even easier for people to incorporate ‘exercise snacks’ into their day,” says Martin Gibala, a professor of kinesiology at McMaster and senior author on the study.

“Those who work in office towers or live in apartment buildings can vigorously climb a few flights of stairs in the morning, at lunch, and in the evening and know they are getting an effective workout.”

Previous studies had shown that brief bouts of vigorous exercise, or sprint interval training (SIT), are effective when performed as a single session, with a few minutes of recovery between the intense bursts, requiring a total time commitment of 10 minutes or so.

For this study, researchers set out to determine if SIT exercise snacks, or vigorous bouts of stairclimbing performed as single sprints spread throughout the day would be sufficient enough to improve cardiorespiratory fitness (CRF), an important healthy marker that is linked to longevity and cardiovascular disease risk.

One group of sedentary young adults vigorously climbed a three-flight stairwell, three times per day, separated by one to four hours of recovery. They repeated the protocol three times each week over the course of six weeks. The researchers compared the change in their fitness to a control group which did not exercise.

“We know that sprint interval training works, but we were a bit surprised to see that the stair snacking approach was also effective,” says Jonathan Little, assistant professor at UBC’s Okanagan campus and study co-author. “Vigorously climbing a few flights of stairs on your coffee or bathroom break during the day seems to be enough to boost fitness in people who are otherwise sedentary.”

In addition to being more fit, the stair climbers were also stronger compared to their sedentary counterparts at the end of the study, and generated more power during a maximal cycling test.

In future, researchers hope to investigate different exercise snacking protocols with varying recovery times, and the effect on other health-related indicators such as blood pressure and glycemic control.

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Researchers find brief, intense stair climbing is a practical way to boost fitness

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More information: Elizabeth M. Jenkins et al, Do Stair Climbing Exercise “Snacks” Improve Cardiorespiratory Fitness?, Applied Physiology, Nutrition, and Metabolism (2019). DOI: 10.1139/apnm-2018-0675

https://medicalxpress.com/news/2019-01-short-bouts-stairclimbing-day-boost.html

Fighting deadly drug resistant bacteria in intestines with new antibiotic

A new antibiotic developed by a Flinders University researcher is being heralded as a breakthrough in the war against a drug resistant superbug.

Bacteria are winning the fight against antibiotics as they evolve to fight off traditional treatments, threatening decades of advancements in modern medicine, with predictions they will kill over 10 million people by 2050.

The scientific development of new, effective and safe antibiotics is crucial in addressing the ever-growing threat posed by drug resistant bacteria around the world.

Clostridium difficile infection (CDI) is a potentially deadly infection in the large intestine most common in people who need to take antibiotics for a long period of time, particularly in Australia’s ageing population.

Dr. Ramiz Boulos, adjunct research associate at Flinders University and CEO of Boulos & Cooper Pharmaceuticsals, says the fact CDI is becoming resistant to traditional antibiotics is alarming and highlights the need to develop more effective treatments.

“Cases of CDI disease are rising and the strains are becoming more lethal. If there is an imbalance in your intestines it can begin to grow and release toxins that attack the lining of the intestines which leads to symptoms,” says Dr. Boulos.

Over the past ten years, various strains of C. difficile have emerged, and are associated with outbreaks of severe infections worldwide. One particular strain is easily transmitted between people and has been responsible for large outbreaks in hospitals in the United States and Europe.

“It’s concerning when you consider CDI is one of the most common infections acquired during hospital visits in the Western hemisphere, and the most likely cause of diarrhoea for patients and staff in hospitals.”

But when doses of a new antibiotic called Ramizol were given to hamsters infected with a lethal dose of the bacteria, a significant proportion of hamsters survived the infection.

In a recent safety study in rats evaluating the effect of repeated exposure of the antibiotic, no rats experienced serious side effects or changes in weight.

“Our research indicates Ramizol is an extremely well-tolerated antibiotic in rats, with good microbiology and antioxidant properties. It also has high chemical stability and is scalable because of the low cost of manufacturing, which could make it a viable treatment option.”

Forty-eight rats were given a high dose of a new class of antibiotic for 14 days to assess its safety.

The research, which was undertaken jointly by Boulos & Cooper Pharmaceuticals, US- based Product Safety Labs and ToxStrategies and Flinders University was recently published in journal Scientific Reports.

“We are pleased with these results for two reasons. Firstly, we were able to give the rats a very high dose without mortalities or side effects,”

“Additionally, there were no changes in mean body weight, weight gain, food consumption or food efficiency for male and female rats attributable to Ramizol.”

“We believe Ramizol has the potential to be the standard of care for treating CDI and has the potential to be a blockbuster drug.”

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Antibiotic promise in superbug war

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More information: Katherine Sibley et al, A 14-day repeat dose oral gavage range-finding study of a first-in-class CDI investigational antibiotic, in rats, Scientific Reports (2019). DOI: 10.1038/s41598-018-36690-9

https://medicalxpress.com/news/2019-01-deadly-drug-resistant-bacteria-intestines.html

Nabriva Therapeutics to host analyst and investor meeting

Analyst and Investor Meeting to be held in New York on January 23 at 8:30 am.

Webcast: https://edge.media-server.com/m6/p/r4gw4hec
https://thefly.com/landingPageNews.php?id=2851161

Novavax Nears Maternal Immunization Results for RSV Vaccine

The state of maternal immunization is much different now than from when Gregory M. Glenn, MD, first started in healthcare. It was a widely studied field, but still not as practiced in pregnant women.

Now, Glenn, president of Research & Development for Novavax Inc., and his team of investigators are at the cusp of revolutionary development for maternal vaccines.

The Maryland-based clinical-stage vaccine company intends to share data in the following weeks on its first clinical trial of an investigative respiratory syncytial virus (RSV) vaccine in third-trimester pregnant women. Its findings and eventual successive studies could alter the scope of care for RSV, the most common cause of bronchiolitis and pneumonia in children younger than 1 year old in the US.

The trial—which has been ongoing for 4 years and has assessed the potential vaccine in about 3000 treatment-eligible pregnant subjects in that time—has been carried out by teams comprised of RSV, vaccination, and maternity-care specialists across 11 countries. “This is an incredible number of people working on a trial,” Glenn told MD Magazine®. “And because they’re on the front line, they are extremely excited at the prospect of having a vaccine for infants.”

Glenn also noted at least 1 other party’s particular interest in the development of an RSV vaccine: the Bill & Melinda Gates Foundation granted $89 million for the outside costs of the trial in 2015.

Global Implications

If the phase 3 results indicate the Novavax vaccine was capable of reaching its primary endpoint—reduced incidence of medically significant RSV lower respiratory tract infection (LRTI) with either hypoxemia or tachypnea in infants through 90 days of life—and key secondary endpoints, it could eventually become the first US Food and Drug Administration (FDA) approved RSV vaccine indicated for infants.

Investigator Pedro A. Piedra, MD, a professor in the Department of Molecular Virology and Microbiology, and Pediatrics at Baylor College of Medicine, explained to MD Mag that the international focus of the study was for good purpose—RSV is recognized by the World Health Organization (WHO) as causing significant morbidity and mortality risk in children 5 years and younger, with no vaccines available.

“Children most at risk are under 6 months of age,” Piedra said. “But to target them with vaccination becomes very difficult. We often think about giving children vaccines at 2 to 6 months. This leaves the concept of maternal immunization.”

Investigators randomized pregnant women aged 18 to 40 years 2:1 to receive vaccine or placebo, respectively. Though no data pertaining to the vaccine’s efficacy is yet available, investigators have received some indication of its safety and tolerability. Glenn noted that an FDA-approved safety data monitoring board was granted unblinded observation of the trial results.

Since starting the study, the Novavax team received no notification of unsafe events that would require them to suspend or prematurely end the study. Piedra emphasized this observation spanned the entire four-year duration, as that is how long it took the investigators to fulfill patient participation standards.

“One always has to be cautious, but I’m cautiously optimistic that the vaccine will meet its primary outcome,” Piedra said.

Piedra noted alternative therapies for pediatric RSV are limited. Monoclonal antibodies with extended half-life have shown capability to protect infants from maternal birth through early childhood, yet carry a greater market price and risk of safety than a vaccine would. There’s also something to be said for a vaccine’s potential as a widespread, long-term influencer in pediatric pulmonary health.

“It’s important to understand RSV is a global pathogen,” Piedra explained. “The majority of deaths occur in low-resourced countries, but it’s the number 1 cause of hospitalization in children under the age of 1 in US. It’s also associated with increased asthma risk within a patient’s first decade of life.”

Long Wait, Long-Term Benefits

It would be interesting, he suggested, to see the both the acute and long-term impacts of a vaccination down the road.

Glenn recalled a time when the majority of infants and young children in the intensive care unit could have been practically split by 2 specialties: gastroenterology, and pulmonary. The former is no longer a driver of pediatric disease; the development of a rotavirus vaccine resolved many issues in the field. He projects a similar outcome for the latter with a capable RSV vaccine.

“From a biotech standpoint, it’s got to be one of the biggest pieces of news this year, just because of the impact,” Glenn said.

Beyond a November 2017 futility analysis allowed by the FDA, Glenn, Piedra and the investigators are not aware of any impeding outcome data. But there’s optimism—due to previous results, interim discussion, and the scale of the trial itself.

“It’s been a long wait,” Glenn said.

https://www.mdmag.com/medical-news/novavax-nears-maternal-immunization-results-for-rsv-vaccine

Why the hit to Tyme Technologies

Shares of Tyme Technologies (NASDAQ:TYME) fell 35% on Friday after the biotech released data from a small phase 2 study of its oncology drug SM-88 in patients with advanced pancreatic cancer. The data was scheduled to be presented at the American Society of Clinical Oncology’s 2019 Gastrointestinal Cancers Symposium today.

The headline of the press release sounds great, noting that the drug “improves survival” — but there wasn’t a control group in this midstage trial. All the patients got the drug, and Tyme is just comparing the survival data to historical controls.

Specifically, the company notes that 79% of the 14 third-line patients in the trial — those who had failed two prior therapies — were alive after a median follow-up of 4.7 months, which is more than double the two-month median survival based on a retrospective analysis of third-line patients in 19 historical trials.

The problem with historical controls is that it’s really hard to know if the 14 patients have the same characteristics as the patients who were in the previous clinical trials. And even if the patients were fairly similar, the history of best standard of care has generally improved over time, so historical controls have typically gotten better for most types of cancer.

The company notes that eight of the 17 evaluable patients — which includes some second-line and fourth-line or later patients — had “stable disease or better.” But when you go to the slides of the presentation for more details, it shows that only two of those patients had an actual response at their target lesion (and a partial response at that). The other six had stable disease. And the definition of stable disease is actually pretty broad — three of the six had tumors that grew after two months.

Tyme argues that response rate in pancreatic cancer isn’t a good indicator of survival because there’s substantial scar tissue in the tumor, which will still show up on a scan, even if the drug is working.

To make matters worse, the poster on the company’s website initially had the wrong graph of responses that included extra patients. Tyme said in an SEC statement that the company changed the figure because it included scans of patients who weren’t at two months. It appears to be an honest mistake, but investors may be questioning whether there’s more to it than that.

This year, Tyme plans to advance SM-88 into a clinical trial designed to get the drug approved for third-line pancreatic cancer. Presumably, the Food and Drug Administration will require that study to have a control arm comparing SM-88 to either placebo or perhaps physicians’ choice, as there’s no standard of care for late-line patients.

Based on the small number of patients and lack of responses in the data released today, it’s hard to know whether the drug is actually working well enough to see an increase in survival in a controlled clinical trial.

https://www.fool.com/investing/2019/01/18/heres-why-tyme-technologies-fell-35-on-friday.aspx

Forty Seven to hold KOL breakfast symposium

Key Opinion Leader Breakfast Symposium to discuss the company’s initial development strategy for FSI-174 will be held in New York on January 22 at 8:30 am.

Webcast: https://ir.fortyseveninc.com/events-and-presentations
https://thefly.com/landingPageNews.php?id=2851155

Foamix to host research and development day

Research and Development Day to be held in New York on January 24 at 12 pm.

Webcast: http://lifesci.rampard.com/20190124b/reg.jsp
https://thefly.com/landingPageNews.php?id=2851163