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Was there any HemoDefend update? I messed the end of the Q1 call.
Cytosorb was granted FDA Breakthrough Device for removal of Brilinta last month.
How long would it typically take to get approval via FDA Breakthrough Device?
Haywire Immune Response Eyed In Coronavirus Deaths, Treatment
Researchers are looking at treatments to suppress ‘cytokine storm,’ increasingly linked to the most severe Covid-19 cases
A laboratory at Regeneron Pharmaceuticals, whose anti-inflammatory drug is being tested to treat Covid-19.By Joseph Walker and Jared S. Hopkins
April 9, 2020 7:00 am ET
An immune system gone haywire may be doing more damage than the coronavirus itself in patients with the severest forms of Covid-19, doctors and scientists say, a growing theory that could point the way to potential treatments.
Much remains unknown about the path the virus takes in the sickest patients, but an increasing number of experts believe a hyperactive immune response, rather than the virus, is what ultimately kills many Covid-19 patients.
The out-of-control immune response eventually causes the patients’ lungs to stop delivering oxygen to the rest of organs, leading to respiratory failure and in some cases death, the experts say. The malfunctioning immune system may be driving the rapid decline in lung function experienced by some patients, including younger and relatively healthy ones, after the initial onset of symptoms, doctors say.
Anatomy of a Cytokine Storm
An overactive immune response is thought to play a role in the disease progression of the sickest Covid-19 patients.
Coronavirus infects lung cells.
1
Coronavirus
Immune cells, including macrophages, identify the virus and produce cytokines, part of the body's inflammatory response against infection.
2
Lung Cells
Cytokines attract more immune cells, such as white blood cells, which in turn produce more cytokines, creating a cycle of inflammation that damages the lung cells.
Macrophage
3
Fibrin
Alveoli
Damage can occur through the formation of fibrins, scar tissue that impede oxygen from passing into the bloodstream.
Cytokines
Weakened blood vessels allow fluid to seep in and fill the lung cavities, leading to respiratory failure.
5
As scientists race to better understand the phenomena, pharmaceutical companies including Roche Holding AG are partnering with hospitals to explore whether drugs proven to tamp down an out-of-control immune response could help the sickest Covid-19 patients.
Some doctors are already administering the drugs to patients who are unable to breathe without the support of ventilators, or to prevent deterioration of patients who appear ready to slip into respiratory failure.
The coronavirus pandemic has revived a debate over one of the most divisive concepts in American politics: Should patients have to pay for their health care? WSJ explores what works, and what doesn’t, in a universal health-care system. Video and Illustration: Jaden Urbi
“You remove one piece of the storm, and it can quiet the whole thing,” said Kevin Tracey, president of the Feinstein Institutes for Medical Research at Northwell Health, which is testing Kevzara, an anti-inflammatory drug from Regeneron Pharmaceuticals Inc.
Doctors have used the term “cytokine storm” to describe an overactive immune response triggered by external pathogens such as bacterial and viral infections.
Proteins called cytokines are part of the immune system’s arsenal for fighting disease. When too many are released into the bloodstream too quickly, however, it can have disastrous results, including organ failure and death.
As with other diseases, it is a mystery why cytokine storms are experienced by some but not all Covid-19 patients, doctors say. Genetics may be a factor.
In the most severe coronavirus patients, the disease appears to have two stages, doctors and researchers say. First the immune system fails to respond quickly or effectively enough to the virus. Then the immune response becomes too aggressive and floods the body with cytokines.
The surge of cytokines damages blood vessels and allows fluids to seep into the lungs, filling them up like water balloons, doctors say.
“The virus initiated it,” said Ya-Chi Ho, an assistant professor at the Yale School of Medicine who studies infectious diseases. “The second problem is our immune system handled it wrong, and induces this cytokine storm and clogs our lungs. That’s why patients die.”
Testing for the new coronavirus.
PHOTO: GERALD HERBERT/ASSOCIATED PRESS
Drugs called corticosteroids can be used to treat patients with cytokine storms, but studies are mixed on their effectiveness, with some studies indicating that Covid-19 patients may be at a higher risk of death when treated with steroids. Some doctors are reluctant to use steroids because they broadly dampen the immune response, which is risky in patients fighting infections.
Drugs targeting specific cytokines rather than the entire immune system may be more effective, doctors say.
Among the most promising targeted treatments, doctors say, is Roche’s rheumatoid-arthritis drug tocilizumab, which is marketed under the brand name Actemra. The drug was approved in 2017 to treat cytokine storms caused by cancer treatments known as CAR-T cell therapies.
On Tuesday, a federal agency that supports health research said it is committing $25 million to accelerate a late-stage study of Actemra in Covid-19 patients.
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Last month, doctors from Seattle’s Swedish Health Services used Actemra to treat a 45-year-old emergency-room physician who was infected while caring for patients from a nursing home in Kirkland, Wash.
The man was transferred to Swedish and put on life support after his lungs and kidneys began to fail, said Samuel J. Youssef, a cardiothoracic surgeon at Swedish. Lab tests showed the man’s inflammation levels were 200 times greater than the normal range, indicating he might be suffering from a cytokine storm.
The doctors at Swedish decided to administer Actemra after discussing a small Chinese study that had shown that 21 Covid-19 patients with high levels of inflammation had been successfully treated with the drug.
Over the next two days, the patient’s inflammation levels began to decline and his blood-oxygen levels increased, Dr. Youssef said. After a week, he was well enough to be taken off life support on March 23, and was released from the hospital on Sunday.
“All we did was quiet the storm and support his body—his kidneys, his lungs, his heart—to give him the time to fight the virus,” said Dr. Youssef, who attributes the recovery both to Actemra as well as other interventions like being put on life support.
CytoDyn Inc., a Vancouver, Wash.-based biotech company, said 10 severely sick Covid-19 patients showed signs of recovering three days after being infused with its experimental HIV drug leronlimab, which may block the production of inflammatory cytokines. Three of the patients were taken off ventilators, including two who have since been discharged from care, according to CytoDyn.
The company is studying its drug in a trial for patients with mild-to-moderate symptoms and expects to start one for severely sick patients.
Swedish Orphan Biovitrum AB expects results in July from a study evaluating its rheumatoid-arthritis drug Kineret in combination with an antibody called emapalumab in patients in Italy, said Milan Zdravkovic, Sobi’s head of research and development.
Novartis AG and Incyte Corp. said they plan to start clinical trials of their drug ruxolitinib in Covid-19 patients with cytokine storm. The drug, marketed as Jakafi in the U.S., is approved to treat rare blood cancers.
Write to Joseph Walker at joseph.walker@wsj.com and Jared S. Hopkins at jared.hopkins@wsj.com
Wall Street Journal: Haywire Immune Response Eyed In Coronavirus Deaths, Treatment
https://www.wsj.com/articles/haywire-immune-response-eyed-in-coronavirus-deaths-treatment-11586430001
EU approval for Novartis' Kymriah and Gilead's Yescarta should be announced within 67 days of receiving CHMP recommendation on 29.06.18
Strokes / Chemotherapy
I recently read two articles about Strokes and Chemotherapy.
Strokes. It has been reported that following a major stroke, over the next couple of days, the spleen releases a plethora of inflammatory cytokines and chemokines which cause further damage to brain cells. I was wondering if the filter could be used immediately after a stroke to protect the brain from further damage?
Chemotherapy. It has been reported that Chemotherapy triggers chronic inflammation that can promote aggressive tumor growth. I was wondering if the filter could be used during and after the administration of chemotherapy to minimise these high risk side effects?
If so, Cytosorbents could make an enormous contribution to patients' quality of life and survival.
Does any one have any further info or comments on this?
Novartis submitted their filing for EU priority review for Kymriah, CAR-T therapy, on November 6, 2017 and announced it had been accepted for priority review on January 17th 2018. I'm not sure which of the above dates is considered to be the starting date but the results are supposed to be announced within 150 days (if there are no delays). In theory that could be next week or within the next two and a half months.
Does that mean Biel knew the meeting was postponed on March 8th?
Please can someone give the definitive date Biel received the letter about the postponed meeting.
I can't find anything on the FDA site announcing that the meeting has been postponed.
Investors update?
I thought the update was put back to the start of the week
When is the next meeting with the FDA concerning RecoveryRX?
Sometime in July?
From my own experience Actipatch really works.
Here in the UK the price has really dropped.
Actipatch was £27 ($43) a year ago. Now it is £9.99 ($16.) for the 720 hour version
http://www.amazon.co.uk/dp/B007RE48W8/?tag=salebuyus-21
Joe Noel still working for Biel?
Looking at the Yahoo message boards for his company yesde. Let's hope not.
http://messages.finance.yahoo.com/mb/YESDE.OB
The problem started because the CEO made the announcement that Biel was expecting a near term decision from the FDA on Recovery RX. I've never seen any other CEO make a statement like this. The norm is to wait for clearance and then announce within 72 hours.
As 6 weeks has passed and nothing has happened, all credibility is lost.
I believe if this is ever passed the price won't rise much as Biel will start selling millions of shares to raise money which will neutralise any big rise in pps.
I hope I'm wrong...
Still no financials?!? I guess they are desperately hoping for FDA approval to arrive soon. Do you think they are holding them back to cover up the probable lack of sales and probable extensive dilution?
Why would Biel bring Joe Noel back?
It throws this whole new run into doubt imo. It is impossible to know whether FDA approvals are close or not. It could just be another pump and dump to raise money.
Is Joe Noel officially working for Biel again?
Can anyone give a definitive answer.
Is Joe Noel officially working for Biel again?
Please can someone email Andy / Biel and ask the question directly. If so, please can Biel explain his role and the thinking behind it !!!