‘Drug Factory’ Implants Could Eliminate Specific Lung Cancer

Rice University and Baylor College of Medicine researchers have shown they can seradicate advanced-stage mesothelioma tumor in mice in just a few days with a treatment combining Rice’s cytokinedrug factoryimplants and a checkpoint inhibitor drug.

The researchers administered the drug-producing beads, which are no larger than the head of a pin, next to tumors where they could produce continuous, high doses of interleukin-2 (IL-2), a natural compound that activates white blood cells to fight cancer. The study, published online today in Clinical Cancer Research, is the latest in a string of successes for the drug-factory technology invented in the lab of Rice bioengineer Omid Veiseh, including Food and Drug Administration (FDAapproval to begin clinical trials of the technology this fall in ovarian cancer patients.

From the beginning, our objective was to develop a platform therapy that can be used for multiple different types of immune system disorders or different types of cancers,” said Rice graduate student Amanda Nash, who spent several years developing the implant technology with study co-lead author Samira Aghlara-Fotovat, a fellow student in Veiseh’s lab.

The cytokine factories consist of alginate beads loaded with tens of thousands of cells that are genetically engineered to produce natural IL-2, one of two cytokines the FDA has approved for treatment of cancer. The factories are just 1.5 millimeters wide and can be implanted with minimally invasive surgery to deliver high doses of IL-2 directly to tumors. In the mesothelioma study, the beads were placed beside tumors and inside the thin layer of tissue known as the pleura, which covers the lungs and lines the interior wall of the chest.

I take care of patients who have malignant pleural mesothelioma,” said Dr. Bryan Burt, professor and chief of Baylor’s Division of Thoracic Surgery in the Michael E. DeBakey Department of Surgery. “This is a very aggressive malignancy of the lining of the lungs. And it’s very hard to treat completely by surgical resection. In other words, there is often residual disease that is left behind. The treatment of this residual disease with local immunotherapy — the local delivery of relatively high doses of immunotherapy to that pleural space — is a very attractive way to treat this disease.”

Veiseh said the mesothelioma study began when Burt and Baylor surgeon and associate professor Dr. Ravi Ghanta heard about the early results of ovarian cancer animal tests Veiseh’s team was conducting with collaborators at the University of Texas MD Anderson Cancer Center. In March, Veiseh and MD Anderson collaborators published a study showing IL-2-producing beads could eradicate advanced-stage ovarian and colorectal tumors in mice in less than a week.

They were really impressed by the preclinical data we had in ovarian cancer,” Veiseh said of Burt and Ghanta. “And they asked the question, ‘Could we actually leverage the same system for mesothelioma?’

Source: https://blogs.bcm.edu/

No More Glasses for Blurry Vision

New eye drops can limit the use for reading glassesVuity has just been approved by the Food and Drug Administration (FDA), and local ophthalmologists say it can be a life-changerThe drops are meant for people dealing with Presbyopia, an age-related eye issue that causes blurry vision

We all know the reading glasses are annoying,” said Dr. Ella Faktorovich, an ophthalmologist with Pacific Vision Institute. “Within 15 minutes you can see your computer, you can see your phone so you can really improve the range of vision. I think it is huge.” She says the drops target the focusing mechanism in the eye. The drops shrink the pupils and increase focus on theeye.

There are many kinds of this medicine in trials, but this is the first to be approved,” she said. “It is pretty remarkable.” It can help people like Lovester Law, who is currently writing a book. He says he spends hours looking at a screen to write“After I read too much or write to long, I just have to close my eyes and relax,” he explained.

“If we live long enough our eyes are going to age, they are not going to be like they used to be.” People who want the drops will have to consult an eye doctor, because they are only available through a prescription. Doctors at UCSF say this breakthrough can be a catalyst for future eye treatment. The data we have shows that it really really works,” stated Julie Schallhorn, Associate Professor of ophthalmology at UCSF. “It is an exciting time to be in this field, and an exciting time for our patients.

The FDA approval of VUITY was based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety and tolerability of VUITY for the treatment of presbyopia.

Source: https://news.abbvie.com/

The FDA Approved the First Online Vision Test

The Food and Drug Administration (FDA) on August 16 approved the first online visual acuity test made by the telehealth company Visibly. This clearance will allow adults ages 22 to 40 to evaluate their vision from the convenience of their homes. The FDA approval may increase access for people who are in need of a renewed prescription for glasses or contacts but cannot travel to an appointment. However, it’s not a replacement for an in-person eye exam.

During the pandemic, a lot of people delayed elective health care that was really important,” said Yuna Rapoport, MD, MPH, a board-certified ophthalmologist at Manhattan Eye. “Overall, this remote vision test is helpful. If you really want an accurate prescription, and there’s a way to get to a doctor’s office, I would still say that that’s a better option.”

A visual acuity test is one of the most important components of an eye exam. It measures how well you can see by testing the smallest letters or images you can read clearly.

According to Visibly, the online visual test is best for “people whose vision has not changed, have recently completed a comprehensive eye exam,” and are looking to renew an expired prescription. The test is not a substitute for, nor does it provide screening or diagnosis for eye health or eye diseases, which should be performed by a licensed provider, according to the FDA.

Paul Foley, Visibly’s chief operating officer, said in a press release that the online vision test will increase at-home use and complement in-person eye care. The test takes about six minutes to complete and 90% of the prescriptions are issued within 24 hours, according to the company.

Source: https://www.govisibly.com/
AND
https://www.verywellhealth.com/

Obesity Drug Achieves Weight Loss of 24 kg

People with obesity lost 24 kilograms on average when they were treated with the highest dose of a new hunger-blocking drug in a large clinical trial. “It’s really exciting. The weight loss they’re showing is dramatic – it’s as much as you get with successful bariatric surgery,” says Michael Cowley at Monash University in Melbourne, Australia, who wasn’t involved in the research.

The drug used, called tirzepatide, combines synthetic mimics of two hormones known as GLP-1 and GIP that our guts naturally release after we eat to make us feel full. In a late-stage clinical trial, more than 2500 people in nine countries, who weighed 105 kilograms on average at baseline, were asked to give themselves weekly injections of tirzepatide at low, medium or high doses or a placebo for 72 weeks, without knowing which one they were taking.

The highest dose of tirzepatide was most effective, resulting in 24 kilograms of weight loss on average, equivalent to a 22.5 per cent reduction in body weight. In comparison, participants taking the placebo lost just 2 kilograms on average. The results were announced on 28 April by US pharmaceutical giant Lilly, which is developing the drug.

In June 2021, the US Food and Drug Administration approved another obesity drug called semaglutide, which contains a GLP-1 mimic on its own, without the addition of GIP. Semaglutide also promotes weight loss, but by about 15 per cent on average, suggesting that the added GIP component in tirzepatide gives an extra boost, says Cowley. Like semaglutide, tirzepatide can trigger side effects such as nausea, vomiting, diarrhoea and constipation that seem worse at higher doses. However, doctors’ experience withsemaglutide has revealed that starting patients on low doses and gradually increasing them can avoid these side effects, and the same may be true for tirzepatide, says Joseph Proietto at the University of Melbourne in Australia. One advantage of obesity drugs is that they can be discontinued if necessary, says Proietto. “The downside of bariatric surgery is that you can never ever have a normal meal again, not even for a special occasion,” he says. “With medication, you can still do this.”

Source: https://www.monash.edu/
AND
https://www.newscientist.com/

Successful Transplant of Porcine Heart into Adult Human

In a first-of-its-kind surgery, a 57-year-old patient with terminal heart disease received a successful transplant of a genetically-modified pig heart and is still doing well three days later. It was the only currently available option for the patient. The historic surgery was conducted by University of Maryland School of Medicine (UMSOM) faculty at the University of Maryland Medical Center (UMMC), together known as the University of Maryland Medicine.

This organ transplant demonstrated for the first time that a genetically-modified animal heart can function like a human heart without immediate rejection by the body. The patient, David Bennett, a Maryland resident, is being carefully monitored over the next days and weeks to determine whether the transplant provides lifesaving benefits. He had been deemed ineligible for a conventional heart transplant at UMMC as well as at several other leading transplant centers that reviewed his medical records.

 “It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice,” said Mr. Bennett, the patient, a day before the surgery was conducted. He had been hospitalized and bedridden for the past few months.  I look forward to getting out of bed after I recover.

The U.S. Food and Drug Administration granted emergency authorization for the surgery on New Year’s Eve through its expanded access (compassionate use) provision. It is used when an experimental medical product, in this case the genetically-modified pig’s heart, is the only option available for a patient faced with a serious or life-threatening medical condition. The authorization to proceed was granted in the hope of saving the patient’s life.

“This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis. There are simply not enough donor human hearts available to meet the long list of potential recipients,” said Bartley P. Griffith, MD, who surgically transplanted the pig heart into the patient. Dr. Griffith is the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery at UMSOM. “We are proceeding cautiously, but we are also optimistic that this first-in-the-world surgery will provide an important new option for patients in the future.”

Considered one of the world’s foremost experts on transplanting animal organs, known as xenotransplantation, Muhammad M. Mohiuddin, MD, Professor of Surgery at UMSOM, joined the UMSOM faculty five years ago and established the Cardiac Xenotransplantation Program with Dr. Griffith. Dr. Mohiuddin serves as the program’s Scientific/Program Director and Dr. Griffith as its Clinical Director.

“This is the culmination of years of highly complicated research to hone this technique in animals with survival times that have reached beyond nine months. The FDA used our data and data on the experimental pig to authorize the transplant in an end-stage heart disease patient who had no other treatment options,” said Dr. Mohiuddin.The successful procedure provided valuable information to help the medical community improve this potentially life-saving method in future patients.

Source: https://www.medschool.umaryland.edu/

Viagra Users Are 69% Less Likely to Develop Alzheimer’s

Viagra could be a useful treatment against Alzheimer’s disease, according to a US study. Alzheimer’s disease, the most common form of age-related dementia, affects hundreds of millions of people worldwide. Despite mounting numbers of cases, however, there is currently no effective treatment.

Using a large gene-mapping network, researchers at the Cleveland Clinic integrated genetic and other data to determine which of more than 1,600 Food and Drug Administration-approved drugs could be an effective treatment for Alzheimer’s disease. They gave higher scores to drugs that target both amyloid and tau – two hallmarks of Alzheimer’s – compared with drugs that targeted just one or the other.

US scientists say users of sildenafil – the generic name for Viagra – are 69% less likely to develop the form of dementia than non-users

“Sildenafil, which has been shown to significantly improve cognition and memory in preclinical models, presented as the best drug candidate,” said Dr Feixiong Cheng, the study lead.

Researchers then used a database of claims from more than 7 million people in the US to examine the relationship between sildenafil and Alzheimer’s disease outcomes by comparing sildenafil users to non-users.

They found sildenafil users were 69% less likely to develop Alzheimer’s disease than non-sildenafil users after six years of follow-up. To further explore the drug’s potential effect on Alzheimer’s disease, researchers developed a lab model that showed that sildenafil increased brain cell growth and targeted tau proteins, offering insights into how it might influence disease-related brain changes. Cheng cautioned that the study does not demonstrate a causal relationship between sildenafil and Alzhemer’s disease. Randomised clinical trials involving both sexes with a placebo control were needed to determine sildenafil’s efficacy, he said.

Dr Ivan Koychev, a senior clinical researcher at the University of Oxford, who was not involved in the study, said it was “an exciting development” because “it points to a specific drug which may offer a new approach to treating the condition”.

Prof Tara Spires-Jones, deputy director of the Centre for Discovery Brain Sciences at the University of Edinburgh, said there were several important limitations to consider. “While these data are interesting scientifically, based on this study, I would not rush out to start taking sildenafil as a prevention for Alzheimer’s disease.”

Dr Susan Kohlhaas, director of research at Alzheimer’s Research UK, said: “Being able to repurpose a drug already licensed for other health conditions could help speed up the drug discovery process and bring about life-changing dementia treatments sooner. “Importantly, this research doesn’t prove that sildenafil is responsible for reducing dementia risk, or that it slows or stops the disease. The only way to test this would be in a large-scale clinical trial measuring sildenafil effect against the usual standard of care.”

The findings were published in Nature Aging.

Source: https://www.theguardian.com/

Pfizer CEO: “Very High Level of Confidence” that the Covid Treatment Pill Is Effective Against the Omicron Variant

Pfizer CEO Albert Bourla said he expects the company’s Covid-19 treatment pill to be effective against the omicron variant of the virus causes Covid-19.

The good news when it comes to our treatment, it was designed with that in mind, it was designed with the fact that most mutations are coming in the spikes,” Bourla explained.  “So that gives me very high level of confidence that the treatment will not be affected, our oral treatment will not be affected by this virus.”

Pfizer submitted its application earlier this month to the Food and Drug Administration (FDA) to authorize the pill, Paxlovid, for emergency use. In a clinical trial of people age 18 and over, Pfizer found the pill reduces hospitalization and death by 89% when taken with a widely used HIV drug within three days of the start of symptoms. The pill blocks an enzyme the virus needs to replicate. It is used in combination with HIV drug ritonavir, which slows the human metabolism to allow the Paxlovid to remain active in the body longer at a higher concentration to combat the virus.

https://www.cnbc.com/

Virtual Reality System to Ease Back Pain

A 3-D virtual reality system to treat back pain was approved by the U.S. Food and Drug Administration (FDA) this week. The EaseVRx system is a prescription device for at-home use that combines cognitive behavioral therapy and other behavioral methods to treat patients 18 and older with chronic lower back pain.

Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life,” said Dr. Christopher Loftus, acting director of the Office of Neurological and Physical Medicine Devices in the FDA‘s Center for Devices and Radiological Health.

Pain reduction is a crucial component of living with chronic lower back pain. Today’s authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain,” Loftus said in an agency news release.

A treatment program includes 56 VR sessions that are 2 to 16 minutes long as part of a daily eight-week treatment program. The FDA approval is based on a clinical trial that included 179 patients with chronic lower back pain assigned to one of two eight-week VR programs: the EaseVRx 3-D program or a control 2-D program that did not feature CBT methods.

At the end of treatment, 66% of EaseVRx participants reported a greater than 30% reduction in pain, compared to 41% of those in the control groupA greater than 50% pain reduction was reported by 46% of the EaseVRx users, compared with 26% of those in the control group, according to the FDA.

One, two and three months after treatment, all EaseVRx users still reported a 30% reduction in pain, which was higher than in the control group. Nearly 21% of EaseVRx users reported discomfort with the headset and about 10% reported motion sickness and nausea, but there were no serious side effects associated with the system, which is made by AppliedVR.

Source:  https://www.upi.com/

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/

FDA-approved Drugs Slow or Reverse Alzheimer’s

A research team at Washington University School of Medicine in St. Louis has identified potential new treatment targets for Alzheimer’s disease, as well as existing drugs that have therapeutic potential against these targets.

The potential targets are defective proteins that lead to the buildup of amyloid in the brain, contributing to the onset of problems with memory and thinking that are the hallmark of Alzheimer’s. The 15 existing drugs identified by the researchers have been approved by the Food and Drug Administration (FDA) for other purposes, providing the possibility of clinical trials that could begin sooner than is typical, according to the researchers.

In addition, the experiments yielded seven drugs that may be useful for treating faulty proteins linked to Parkinson’s disease, six for stroke and one for amyotrophic lateral sclerosis (ALS).

Scientists have worked for decades to develop treatments for Alzheimer’s by targeting genes rooted in the disease process but have had little success. That approach has led to several dead ends because many of those genes don’t fundamentally alter proteins at work in the brain. The new study takes a different approach, by focusing on proteins in the brain, and other tissues, whose function has been altered.

In this study, we used human samples and the latest technologies to better understand the biology of Alzheimer’s disease,” said principal investigator Carlos Cruchaga, the Reuben Morriss III Professor of Neurology and a professor of psychiatry. “Using Alzheimer’s disease samples, we’ve been able to identify new genes, druggable targets and FDA-approved compounds that interact with those targets to potentially slow or reverse the progress of Alzheimer’s.”

The scientists focused on protein levels in the brain, cerebrospinal fluid (CSF) and blood plasma of people with and without Alzheimer’s disease. Some of the proteins were made by genes previously linked to Alzheimer’s risk, while others were made by genes not previously connected to the disease. After identifying the proteins, the researchers compared their results to several databases of existing drugs that affect those proteins.

The new study, funded by the National Institute on Aging of the National Institutes of Health (NIH), is published in the journal Nature Neuroscience.

Source: https://source.wustl.edu/