Clinical Trial

UC San Diego These Tiny Robots Can Swim Through Acid to Deliver Stomach Ulcer Drugs Directly

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A fleet of micromotor bots, each measuring half the width of a human hair, have been used to heal stomach ulcers in mice, the first time such bots have been used in experiments in living organisms.

Conventional antibiotic drugs taken orally can get blitzed and blunted by acids in the stomach, but these miniature bots have been shown to withstand the conditions in the gut and pilot themselves towards bacterial infections.

Five days of micromotor antibiotic treatment proved to be slightly more effective than using regular medicine, according to the team from the University of California, San Diego, and the next target is to investigate whether the approach could work for humans too.

“It’s a one-step treatment with these micromotors, combining acid neutralisation with therapeutic action,” says one of the researchers, Berta Esteban-Fernández de Ávila.

One of the smartest parts of the approach is that the tiny bots use the gastric acid for power – their magnesium cores react with the acid, producing hydrogen bubbles that propel the micromotors to their target.

The little bacteria busters are coated with other materials to offer protection and stick to stomach walls.

Not only does the chemical reaction give power to the micromotors, it also reduces acidity in the stomach. The antibiotic layer on board the bots is sensitive to that drop in acid levels, and gets released as a result.

The pH levels in the stomach then go back to normal after 24 hours, and the biodegradable micromotors are dissolved without any harmful residues left behind.

With regular stomach ulcer drugs taken through the mouth, patients are often also given proton pump inhibitors to suppress gastric acid so the drugs can do their work. The problem is, these inhibitors are linked to side effects like headaches, diarrhoea, and even depression.

Having something like this microscopic robot army working against disease would seem to be a much better solution, taking care of both the gastric acid and the bacterial infections at the same time.

It’s going to take a while before the treatment can be safely adapted for humans to use, but many other scientists are also investigating how super-small robots can help and heal the human body – work that could help move the field forward in general.

The researchers behind this new study say there’s still a “significant gap” between testing micromotors and other types of nanobots in a test tube, and actually getting them into living organisms, which is why this study is so significant.

At the same time the researchers are also keen to emphasise that it’s early days for the technique, and they plan to run future tests using different combinations of drugs and different parts of the digestive system.

Other, larger animals could also be in line for tests before the all-clear is given for clinical trials with human patients.

“There is still a long way to go, but we are on a fantastic voyage,” one of the team, Joseph Wang, told Timothy Revell at New Scientist.

The research has been published in Nature Communications.

The scientists also produced a video alongside their work, which you can see below:

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USFDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia

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The U.S. Food and Drug Administration approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

“For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “These patients have few treatments available and today’s approval provides a new, targeted treatment option.”

B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximately 5,970 people in the United States will be diagnosed with ALL this year and approximately 1,440 will die from the disease.

Besponsa is a targeted therapy that is thought to work by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells.

The safety and efficacy of Besponsa were studied in a randomized trial of 326 patients with relapsed or refractory B-cell ALL who had received one or two prior treatments. Patients were randomized to receive treatment with Besponsa or an alternative chemotherapy regimen. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR). Of the 218 evaluated patients, 35.8 percent who received Besponsa experienced CR for a median 8.0 months; of the patients who received alternative chemotherapy, 17.4 percent experienced CR for a median 4.9 months.

Common side effects of Besponsa include low levels of platelets (thrombocytopenia), low levels of certain white blood cells (neutropenia, leukopenia), infection, low levels of red blood cells (anemia), fatigue, severe bleeding (hemorrhage), fever (pyrexia), nausea, headache, low levels of white blood cells with fever (febrile neutropenia), liver damage (transaminases and/or gamma-glutamyltransferase increased), abdominal pain and high levels of bilirubin in the blood (hyperbilirubinemia).

The prescribing information for Besponsa includes a boxed warning that severe liver damage (hepatotoxicity), including blockage of veins in the liver (veno-occlusive disease [VOD] or sinusoidal obstruction syndrome), occurred in some patients who took Besponsa. If hepatotoxicity occurs, doctors should pause treatment or reduce the dose of Besponsa. If VOD occurs, patients should stop taking Besponsa and be given standard VOD treatment, if severe.The boxed warning also includes an increased risk of death for patients who take Besponsa after receiving a certain type of stem cell transplant.

Other serious side effects of Besponsa include a decrease in blood cell and platelet production (myelosuppression), infusion-related reactions and problems with the heart’s electrical pulses (QT interval prolongation). Women who are pregnant or breastfeeding should not take Besponsa because it may cause harm to a developing fetus or a newborn baby.

The FDA granted this application Priority Review and Breakthrough Therapy designations. Besponsa also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of Besponsa to Pfizer Inc.

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Scientists Just Discovered New Kinds of Cells in The Human Brain

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Neuroscientists have discovered a new way to categorise neurons at a molecular level. This will help scientists to compose a ‘parts list’ of the brain and, perhaps, create interfaces that improve its functionality.

Mapping exactly how the human brain functions is, perhaps, the most promising step when it comes to transforming how humans operate on a fundamental level. Discerning brain functions at a molecular level could help us find new ways to combat neurological diseases and even allow us to enhance human intelligence.

Already, a host of innovators are working to develop technology that intertwines with the brain to enhance its functionality; however, before we can deploy such technologies, we need to fully understand how the brain works.

And we just got a little bit closer. Recently, a team of researchers from the Salk Institute and the University of California San Diego announced that they have made a major discovery that could aid us in this effort.

Through a relatively new process, the scientists were able to discover new kinds of brain cells.

According to the co-senior author, Joseph Ecker, professor and director of Salk’s Genomic Analysis Laboratory and an investigator of the Howard Hughes Medical Institute, “Decades ago, neurons were identified by their shape. Now we are taking a molecular approach by looking at this modification of the methylation profile between cells and that tells us what type of cell it is pretty accurately.”

In short, by sequencing the molecular structure of neurons that look the same under a microscope, we can begin to sort them into subgroups to give a better understanding of each subgroup’s functionality.

“We think it’s pretty striking that we can tease apart a brain into individual cells, sequence their methylomes, and identify many new cell types along with their gene regulatory elements, the genetic switches that make these neurons distinct from each other,” Ecker notes.

This research will allow scientists to get a complete “parts list” of each neuron and its function.

According to Chongyuan Luo, a Salk research associate, and co-first author of the research paper, such mapping will open a host of new doors: “There are hundreds, if not thousands, of types of brain cells that have different functions and behaviours and it’s important to know what all these types are to understand how the brain works.”

As previously mentioned, these findings could have a profound impact on how we study and treat neurological disorders. Ecker’s next move is to research molecular differences in the brains of healthy subjects versus those with brain disease.

“If there’s a defect in just one percent of cells, we should be able to see it with this method,” he says. “Until now, we would have had no chance of picking something up in that small a percentage of cells.”

Researchers will be able to pin point the exact cell types that may be responsible for a particular disease. With that knowledge, future research would be able to focus on correcting that abnormality.

“…we can develop, from this information, new tools to be able to study particular cell populations once we know they exist,” says Ecker.

Understanding the brain on this minute of a level will certainly open up a wide range of possibility for the future of treating disease, as well as preparing us for a new level of bionic integration.

This article was originally published by Futurism.

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US FDA issues draft guidance on Child-Resistant Packaging, paediatrics calls for immediate adoption

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US FDA has circulated norms on Child-Resistant Packaging (CRP) in DRUG PRODUCT LABELLING. Paediatricians have appreciated the move and called for its speedy implementation. The guidance is intended to help ensure that such labeling is clear, useful, informative, and to the extent possible, consistent in content and format. The regulator has called to comment on these norms before October this year.

The guidance is intended to assist pharma industry that chooses to include CRP statements in their labeling. It provides information to be included to support CRP statements for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements. In addition for non prescription drug products and those that are marketed under the Over-the-Counter (OTC) Drug Review.

One of the most popular trends in the pharma packaging currently is the ‘Child Resistant Closure Caps’. Keeping in mind the increase in demand for the PET bottles, companies are making an effort to move from their neck finish to a child resistant and squeeze loc enabled finish, said Vimal Kedia, managing director, Manjushree Technopack.

According to junior doctors at the Indira Gandhi Institute of Child Health, Bengaluru, CRP is a critical public health safety aspect. There are scores of children being rushed to hospitals for having consumed drugs mistaking it for a confectionary.

“A child resistant package usually requires a special knack to open it. It is complicated for most children to open the lid. For example, users might have to push or squeeze a lid at the same time to unlock the bottle. It is also possible to make non-re-closable packs, such as blister packs, child resistant by using very strong material or covers that have to be peeled off. The parents should be counseled to keep the medicines out of sight and reach of children, preferably in a locked cupboards which children cannot access it. All brands should have warning labels as a caution to parents, said Dr Radhakrishna Hegde S, Senior Paediatric Consultant Apollo Hospitals, Bannerghatta Road, Bengaluru.

The guidance is recognized by public health experts as only one component of preventing these events. Public health campaigns emphasize the need for consumer education on safe storage practices for medications. When medications are stored in reach and sight of children, these kids are able to gain access to and this defeat CRC in some instances, thereby reducing the effectiveness of the packaging measure. Therefore, FDA advocates that all drugs, irrespective of the type of packaging, be stored safely out of reach and sight of children to further the overall public health efforts to address this safety issue.

FDA regulates certain aspects of drug products’ container closure systems related to safety and efficacy. But it does not include evaluation of testing reports to determine whether a product meets the applicable standards for special packaging as set forth in the Poison Prevention Packaging Act (PPPA) to protect children from unintentional exposure to household substances including food, drugs, and cosmetics.

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There’s a Reason Probiotics Do Very Little – But a New Type of Pill Could Change That

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Probiotics – pricey supplements designed to support the trillions of bacteria blossoming in our guts – have become a big business, with a market that is projected to exceed US$57 billion in the next five years.

“Probiotics are probably the single most important new food category to emerge in the last 20 years,” Scott Bass, the head of the Global Life Sciences team at law firm Sidley Austin LLP and an adviser for the FDA on its first dietary supplement website, told Business Insider.

The idea behind the pills is simple: foster the growth of beneficial bacteria in the gut and curb the growth of the bad bacteria to improve digestion, boost the immune system, and even lower rates of certain diseases.

Putting that idea into practice, however, has proven a bit more complicated than some scientists initially envisioned.

So far, the effects of existing probiotic supplements have been all over the map – sometimes they help, but most of the time, they don’t.

Nevertheless, supplement-makers continue to advertise their pills as beneficial for everything from weight loss to treating lactose intolerance.

The problem is that while most probiotic formulas contain tens of millions of beneficial bacteria, like Lactobacillus acidophilus, fewer than a hundred or so of those bacteria actually make it into your gut.

“Thirty billion Lactobacillus sounds good, but after going through the stomach acid, only about 43 of them survive,” Ian Orme, a distinguished professor of microbiology and pathology at Colorado State University, told Business Insider.

These “good” bacteria are supposed to replace the “bad” bacteria (like Bifidobacteria) and help you feel better.

“In other words these 43 or so bacteria politely ask the million or so anaerobic Bifidobacteria to please leave,” said Orme. “Yeah, sure.”

There are some specific incidences where the research suggests that the pills could actually help.

A rigorous 2014 review of probiotics research concluded that the supplements could be especially helpful for newborns with intensive needs.

Adding “good” bacteria to the guts of infants at risk of developing the life-threatening gut disease necrotising enterocolitis, for example, significantly reduced the chances that they’d come down with the disease.

More recently, researchers have been experimenting with supplements called synbiotics, which combine a probiotic bacterial strain with what’s called a prebiotic – essentially a type of sugar designed to feed the beneficial bacteria and help it thrive in the gut.

The idea is that the pre- and the pro-biotic would work together to provide a combined benefit – while the probiotic settles in and pushes out the “bad” bacteria, the prebiotic hangs around and acts as its food supply, ensuring that the supplement sticks around and does its job.

Just this month, as part of the first large-scale clinical trial of its kind, researchers working in rural India found that newborns who were given a synbiotic were at a substantially lower risk of developing sepsis, a potentially fatal condition characterised by severe infection.

Some small studies have suggested that synbiotics could provide benefits to a range of other conditions influenced by the gut microbiome as well, including obesity, diabetes, and non-alcoholic fatty liver disease, but larger-scale clinical trials focusing on each of those conditions are needed.

So if you see a probiotic – or a synbiotic – for sale at your local health-foods store, know that the existing research backing up its claims is very limited.

This article was originally published by Business Insider.

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