Tenet sees patient volume returning, has $2.7B excess cash

Dallas-based Tenet Healthcare is starting to see patient volume return to pre-COVID-19 levels, the 65-hospital system said in an investor presentation July 16.

The system saw its patient volume drop most significantly in April, with a 33 percent drop in admissions, 55 percent drop in hospital surgical cases and 80 percent drop in its USPI surgical cases. The drop in volume occurred after elective procedures were suspended amid the COVID-19 pandemic.

However, in the first week of June, Tenet said patient admissions have recovered to 90 percent of pre-pandemic levels, hospital surgeries have recovered to 95 percent of pre-pandemic levels and USPI surgical cases have rebounded to 85 percent of pre-pandemic levels.

The patient volume return signals a positive step for Tenet, according to the presentation.
To help mitigate losses from the pandemic, Tenet took several steps, including furloughing 10 percent of its workforce, slashing capital spending and adding liquidity by offering $1.3 billion in secured notes and boosting its line of credit.

The system also received more than $2.5 billion total from various federal relief programs.

“We do appreciate the stimulus we’ve received so far because we did lose a significant amount of revenue in April,” Tenet CEO Ron Rittenmeyer told investors July 16.

As of July 15, the system had about $2.7 billion in excess cash on hand and a credit line of $1.9 billion with no borrowing.

However, Tenet noted that it needs to repay by April 2021 $1.5 billion to Medicare that was received in the form of advance payments.

https://www.beckershospitalreview.com/finance/tenet-sees-patient-volume-returning-has-2-7b-excess-cash.html

Eloxx Pharma up on restart of cystic fibrosis study

Thinly traded micro cap Eloxx Pharmaceuticals (NASDAQ:ELOX) announces the resumption of enrollment in its Phase 2 clinical trial evaluating ELX-02 in cystic fibrosis (CF) patients. It suspended enrollment about three months ago in the Europe and Israel-based study due to COVID-19 disruptions.

ELX-02 is a eukaryotic ribosomal selective glycoside, a molecule that modulates the ribosome, a part of the cell that plays a major role in protein production. It is designed to increase the read-through activity in patients with nonsense mutations, enabling the production of enough full-length protein to restore biochemical activity. CF is caused by the absence of or dysfunction in a protein called CFTR resulting from mutations in the gene that encodes the protein.

Shares up 51% after hours.

https://seekingalpha.com/news/3583971-eloxx-pharma-up-big-on-restart-of-cystic-fibrosis-study

More Publication By Press Release, This Time From Sinovac On A Covid Vaccine

Spreading almost as fast as Covid-19 itself are “publications by press release”. The latest comes from Sinovac, the same company that previously withheld comment on animal studies of its candidate Covid vaccine until the supporting data was available for review.
Not so this time, for what they describe as phase I/II safety trials for their whole killed SARS-CoV-2 candidate called CoronaVax. The company says it expects “to share the data through academic publications.” Until then, we must rely on their credibility for evaluation of the data—an unfortunate state of affairs in the face of a crisis of such magnitude as the one now affecting many millions of people and entire economies. Sinovac does not tell us why they chose to comment on their results before the data can be viewed. Data transparency should be the rule, not the exception, for public announcements.

The vaccine was administered in two doses two weeks apart and blood samples examined 14 days after the second dose. Sinovac claims that in studies of more than 700 hundred people, the vaccine was safe. This claim is made without supporting data regarding adverse events. It would be surprising if there were none. They also claim that more than 90% of those vaccinated as part of the phase II trial made neutralizing antibodies to SARS-CoV-2. They do not report the range of antibody response not discuss the antibody status of those who did not make neutralizing antibodies.
Sinovac also announced that it is building new manufacturing facilities and has reached agreements to test the vaccine in Brazil, a seemingly good choice as infection in that country is high and accelerating.
The most we can conclude from this report is that Sinovac is fully engaged in human trials of its Covid-19 vaccine. We must await the data which underlies any specific claim.

William A. Haseltine is

a scientist, businessman, author, and philanthropist. For nearly two decades, he was a professor at Harvard Medical School and Harvard School of Public Health where he founded two academic research departments, the Division of Biochemical Pharmacology and the Division of Human Retrovirology. He is perhaps most well known for my work on cancer, HIV/AIDS, and genomics.
https://www.forbes.com/sites/williamhaseltine/2020/06/17/more-publication-by-press-release-this-time-from-sinovac-on-a-covid-vaccine/#187fbe93c2e7

Can ‘Nanosponges’ Help Treat Patients With Coronavirus?

With news yesterday out of the UK that the inexpensive and widely available steroid dexamethasone significantly reduced deaths in coronavirus patients who are intubated and those requiring oxygen, following published evidence last month that the antiviral Remdesivir shortened time to recovery, the search for a breakthrough drug or approach that improves survival before approval of a viable vaccine remains illusive.
Add to this the potential for the virus to mutate—already with multiple strains— the search for a new approach would be ideal.
Now, researchers at UC San Diego have pioneered a novel pathway for treating infections using “nanosponges”—a technology that may hold promise for treating patients with SARS-CoV-2, the virus responsible for Covid-19.

Their aim is to use the nanosponges—biodegradable polymers coated with cell membranes and 1000 times smaller than the width of a human hair—as a decoy, ultimately preventing the coronavirus from infecting human cells and then reproducing.
Their research was published today in the Journal Nano Letters.

As opposed to an antiviral drug that works by targeting and trying to stop the virus itself, nanosponges act as a decoy to shield cells, so that the virus cannot infect them. The virus then binds with the nanosponge, rendering it ineffective.
The Rationale for using Nanosponges
This is the way it works: the researchers created tiny nanosponges which are biodegradable polymers and cover them with membranes or coverings that mimic human cells. In this way, the virus or even a toxin will be interested in binding with their surface. As opposed to a virus infecting cells in the body which could multiply and spread the infection, the virus is tricked into infecting the nanosponges which are then unable to multiply, reducing the viral load and hence the opportunity to spread an infection.
A significant aspect of the current SARS-CoV-2 research, Zhang explains, involves approaches to block the interaction of the SARS-CoV-2’s spike protein with 2 key receptors that allow it to attach to, enter and infect human cells: ACE2 and CD147.
“Traditionally, drug developers for infectious diseases dive deep on the details of the pathogen in order to find druggable targets. Our approach is different. We only need to know what the target cells are. And then we aim to protect the targets by creating biomimetic decoys,” said Liangfang Zhang, PhD, lead author of the study, Professor, Department of Nanoengineering, Director Chemical Engineering Program, University of California San Diego.
Zhang, who has been conducting research on nanosponges over the past 10 years, realized that when the coronavirus pandemic began to accelerate, his technology may have the potential to target SARS-CoV-2.
Zhang was able to successfully design 2 types of nanosponges using membranes from human lung cells and specialized white blood cells known as macrophages, each coated with ACE2 and CD147 receptors and infected by the SARS-CoV-2 virus. They were able to successfully develop a nanoparticle decoy with the virus’ natural targets (ACE2 and CD147) to lure SARS-CoV-2 away from normal cells in cell culture.
Their results were quite promising: the nanosponges were shown to be quite effective in cell culture, reducing the infectivity of the virus by up to 90%. These results were achieved in collaboration with Boston University’s National Emerging Infectious Disease Laboratories (NEIDL) using live SARS-CoV-2 virus.
In addition, Zhang’s approach using nanosponges covered with the membranes of macrophages—key white blood cells involved in the inflammatory response to COVID-19 (or other viral infections)—might also be able to bind inflammatory cytokines that are present with “cytokine storm”, an overactive or exaggerated immune response by the body that is potentially fatal.
“Another interesting aspect of our approach is that even as SARS-CoV-2 mutates, as long as the virus can still invade the cells we are mimicking, our nanosponge approach should still work. I’m not sure this can be said for some of the vaccines and therapeutics that are currently being developed,” added Zhang.
Beyond this, Zhang expects that nanosponges would work against any type of virus, especially a new coronavirus—or any virus for that matter—which may be the source of another pandemic.
Zhang predicts that a typical treatment might involve infusion of “trillions of sponges—a huge number, but small volume [about 10 cc]”, but the exact dose would have to be determined by animal and human trials, he added. This would expose the lung with a trillion or more tiny nanosponges that could draw or distract the virus away from healthy cells. Once the virus binds with a nanosponge, “it loses its viability and is not infective anymore, and will be taken up by our own immune cells and digested,” explained Zhang.
The role of using the nanosponge prophylactically, or even as a treatment post- exposure seems attractive to Zhang.  “I think the nanosponges can be used in both a prophylactic manner and a treatment post exposure for SARS-Cov-2. When patients are infected by SARS-CoV-2, as long as the viruses are still in the body such as in the lungs, the nanosponges can bind and neutralize viruses and induce clinical induce clinical improvement.”
Zhang’s team has already conducted some preliminary safety testing in mice but larger scale trials in animal models will soon follow. Human trials are also being planned in the near future, according to Zhang.
Applications for Nanosponges
Over 10 years ago, Zhang’s created the first membrane-cloaked nanoparticles in his lab at UC San Diego. The initial nanosponges he and his team developed were covered with fragments of red blood cell membranes, with the goal to treat bacterial pneumonia. These sponges have now completed the  stages of pre-clinical testing by Cellics Therapeutics, the San Diego startup cofounded by Zhang. The company is currently in the process of submitting an investigational new drug (IND) application to the FDA using red blood cell (RBC) nanosponges to treat patients with methicillin-resistant staphylococcus aureus (MRSA) pneumonia. Cellics estimates that they will begin treating patients next year, according to a press release.
Zhang’s team at UC San Diego have also demonstrated that nanosponges can accomplish targeted delivery of drug to a wound site, bind bacterial toxins that are the mechanism linked to sepsis, as well as bind HIV viral particles before it can infect human T cells.
Zhang explains that nanosponge construction is predicated on the same basic principle. It involves a biodegradable, FDA-approved polymer core coated in a specific type of cell membrane, so that it might be disguised as a red blood cell, or an immune T cell or a platelet cell. The coating or cloaking prevents the immune system from spotting and attacking the particles as dangerous invaders.
“I think of the cell membrane fragments as the active ingredients. This is a different way of looking at drug development,” offered Zhang. “For COVID-19, I hope other teams come up with safe and effective therapies and vaccines as soon as possible. At the same time, we are working and planning as if the world is counting on us.”
Zhang believes a particularly relevant aspect of his current research about SARS-CoV-2 is the fact that “cellular nanosponges are potentially agnostic to viral mutations and new viral species,” potentially shifting the way we approach treatment of the deadly virus.
https://www.forbes.com/sites/robertglatter/2020/06/17/can-nanosponges-help-treat-patients-with-coronavirus/#1668989c5709

Walmart Opening More Healthcare ‘Super Centers’

Walmart Health’s first “super center for basic healthcare services” opened Sept. 13, 2019 in Dallas.  Walmart

Walmart disclosed plans to open more “Walmart Health” centers that feature an array of primary medical services, dental care, and behavioral health services as part of a new model being replicated beyond Georgia into other markets.
Walmart says the new health centers opening this month will be located in Loganville, Georgia, and Springdale, Arkansas. They will be the third and fourth such centers to open in less than a year.
Executives said the new centers build on the first 10,000 square foot facility that opened last fall in Dallas, Georgia, where Walmart shoppers and patients in the community have taken to the concept. A Calhoun, Ga., center already opened and the new Loganville center are about 6,800 square feet, a Walmart spokeswoman confirmed.

The new centers, like the first “Walmart Health” brand center in Dallas, Georgia, offer more services than the 19 “Care Clinics” that take up about 1,500 square feet inside stores elsewhere in Georgia, South Carolina and Texas. The retailer says the Care Clinics remain an important part of their healthcare offerings, but are more limited in service.
“Our existing Walmart Health Centers in Dallas and Calhoun, Georgia, have created a real impact in the months since opening,” Walmart’s senior vice president of health and wellness, Sean Slovenski said in a blog post Wednesday.

“Patients have responded favorably to our low, transparent pricing for key healthcare services, regardless of insurance status,” Slovenski added. “They’re also appreciative of the convenience of our facilities that offer primary and urgent care, labs, x-ray and diagnostics, counseling, dental, optical and hearing services all in one central facility. But don’t just take my word for it.”
The move by Walmart comes as CVS Health opens hundreds of “HealthHubs” which include additional health and wellness items and services beyond what’s already available in the drugstore chain’s MinuteClinics. Meanwhile, Walgreens Boots Alliance has been partnering with an array of companies, testing everything from urgent care in attached centers operated by UnitedHealth Group’s Optum MedExpress unit to Partners in Primary Care Clinics for Medicare beneficiaries that are operated by Humana.
In an interview last year, Slovenski decribed the new Walmart Health centers as “a super center for basic healthcare services.”
The larger Walmart Health Center puts “key health services under one roof,” a first for the world’s largest retailer when it comes to offering primary care, dental, optometry, counseling, laboratory tests, X-rays, hearing, wellness education and behavioral health.
“It’s clear our model is working, but there’s also more to be done to ensure every family has access to care,” Slovenski said. “Walmart Health will continue to expand with additional locations opening in Georgia this year. We owe it to our communities to continue our mission to bring quality care to those who need it, now more than ever.”
https://www.forbes.com/sites/brucejapsen/2020/06/17/walmart-rolling-out-more-healthcare-services-super-centers/#6fcc141f202f

Nursing Homes Account For Over 40% Of U.S. Coronavirus Deaths

Of the U.S.’s more than 116,000 Covid-19 deaths, over 50,000 died in nursing homes or other long-term care facilities, according to a Tuesday analysis by The Wall Street Journal, reaffirming concerns that the country’s oldest and most vulnerable have not been adequately protected during the pandemic.

KEY FACTS

The WSJ reported more than 250,000 residents and staffers at long-term care facilities contracted Covid-19, resulting in at least 50,919 deaths (the death toll is likely higher due to lags and differences in state reporting).

As for how the pandemic claimed so many from nursing homes, fingers are being pointed on both sides of the aisle.

Trump has sourced the issue to facilities with low federal ratings for infection control and some Democratic governors who required nursing homes to take recovering Covid-19 patients.

Democrats have criticized the Trump administration’s response while advocates for the elderly say the federal government hasn’t provided sufficient virus testing and protective gear to allow nursing homes to operate safely.

POLITICO reported Monday that only a little more than half of the nation’s nursing homes received inspections to make sure staff are following proper procedures to prevent coronavirus transmission, a lapse that critics say prevented states from identifying issues at a crucial time.

Key background

The Trump administration hit pause on annual nursing home inspections in March and the Centers for Medicare and Medicaid Services instead tasked state agencies with inspecting facilities for adequate pandemic response practices. However, POLITICO reports that many states affected heavily by the virus chose to prioritize frontline health workers rather than inspectors, delaying in-person checks and leading nearly half of the country’s homes to remain unchecked for more than two months. “If you’re not going in, you’re essentially taking the providers’ word that they’re doing a good job,” said Richard Mollot, the executive director of the Long Term Care Community Coalition, which experts say led to oversights or lapses in appropriate pandemic care.

Key quote

“The lack of federal coordination certainly has impeded facilities’ ability to identify infected persons and to provide care,” Eric Carlson, an expert with the care advocacy group Justice in Aging, said to lawmakers. “That absence remains important as facilities are attempting to open up, which requires an extensive reliance on testing.”

Shocking number

A closely watched academic model from the Institute for Health Metrics and Evaluation is forecasting more than 201,000 coronavirus deaths in the U.S. by October 1.
https://www.forbes.com/sites/jemimamcevoy/2020/06/16/nursing-homes-account-for-over-40-of-us-coronavirus-deaths/#54d56a44300b

Investor’s rude awakening on clinical trials spurs work to speed them for Covid

When Sam Altman, the CEO of artificial intelligence firm OpenAI and a well-known tech investor, saw the pandemic coming, he started investing in biotech companies that could combat it, and fast. Eventually, he had funded roughly 20 different efforts, a mix of investments and philanthropy.
“I think people always try to help in any situation the way they know how,” Altman said. “The one thing I know how to do is fund companies.”
But as he talked to these companies, the tech veteran, who ran the legendary accelerator YCombinator until 2019, was in for a shock. One executive told him a trial would cost about “two.” Two million dollars, Altman asked? That didn’t sound bad. No, the exec said. He meant $200 million.

The fruit of Altman’s frustration: a new effort to speed up Covid-19 clinical trials that is being unveiled Tuesday. As part of that effort, TrialSpark, a startup that is aimed at lowering the cost — and increasing the speed — of clinical trials, will work with companies and researchers seeking to accelerate Covid-19 research.

TrialSpark’s model is based on finding patients digitally, often through social media, and using telemedicine, remote data collection, and even at-home testing and specimen collection to test drugs at home.

“We’re pushing ourselves … to think about things for Covid differently, more urgently,” said Mark Fishman, a Harvard Professor who was the founding president of the Novartis Institutes for Biomedical Research, who has come on board to help with the project. “You know, this is not your standard trial. It has to be done quickly, but it has to be done well. And you’ve seen already the problems of trials being done or reported in a slipshod fashion.”
The effort, known as Project Covalence, got its start on March 21, when Altman fired off a tweet asking for help setting up clinical trials. This is the most expensive and time-consuming part of the process of drug development.
Among the people he connected with was Benjamine Liu, the CEO and co-founder of TrialSpark, which has raised $87 million from investors including Sequoia Capital, Thrive Capital, and John Doerr. Soon, it enticed Michael Mina of the Harvard T.H. Chan School of Public Health to use the platform.
The project’s first study, run by Mina, will be an effort to understand how Covid-19 has moved through Massachusetts using diagnostic tests that check for both the presence of the SARS-CoV-2 virus, which causes Covid-19, and the presence of antibodies to the virus, which indicate that patients have been exposed to the virus and recovered.
Mina said the research will differ from other so-called “serological studies” because it will use sampling methods analogous to political polling techniques to get a representative group of people.
“We all understand that you can’t go to one small community and extrapolate how that population is going to vote, because it can be very biased,” Mina said. The study, he said, “will give us a measure of the effectiveness of all the strategies various policymakers are putting in place.”
Liu, the TrialSpark founder, said the company uses Facebook and Instagram to recruit patients among other methods. For Mina’s trial, large databases akin to this that might be used for political polling are being used.

“We want to be deliberate as the information is collected to make sure we continue to expand the cohort in a way that it’s demographically quite representative,” Liu said.
Part of the advantage, Liu said, is that the platform can remove the need to “reinvent the wheel” every time a trial is started. Also, TrialSpark, he said, can conduct studies outside a hospital, which is important during outbreaks when hospitals are overburdened and patients do not want to go to the hospital because it could increase their risk of becoming infected.
For grant-funded and not-for-profit efforts, like Mina’s and a study sponsored by the biotech resTORbio that will be included in Project Covalence, Liu says that TrialSpark will run studies at cost. For for-profit efforts, TrialSpark will charge its normal rate.
But it won’t always mean that things speed up, Fishman said. “Some of what we’re trying to do is actually put the brakes on things and tell people, look, I’m sorry, that’s going to take you two more months.” That’s another reality of drug development: haste makes waste.

A tech investor’s rude awakening on clinical trials sparks an effort to make them faster for Covid-19