The promising COVID therapy for respiratory failure few have heard of, but will soon - NeuroRx and Relief Therapeutics RLF-100 (Aviptadil)

https://www.businesswire.com ^ | 08.05.2020 | Numerous

[rxsid]

NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19

• Fast Track Designation of RLF-100 for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19 underscores the urgent need for new treatment options for these patients.
• At FDA's request, NeuroRx is submitting an expanded access policy enabling physicians to request RLF-100 for patients who meet this criterion.

June 24, 2020 01:30 AM Eastern Daylight Time

RADNOR, Pa. & GENEVA--(BUSINESS WIRE)--NeuroRx, Inc. (OTC:RLFTF), in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that the U.S. Food and Drug Administration (FDA) awarded Fast Track designation to NeuroRx for the investigation of RLF-100 (Aviptadil) for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19. RLF-100 is a synthetic form of human Vasoactive Intestinal Peptide (VIP) which reduces inflammation in the lungs and protects the alveolar type II cells that are believed to be an entry route for the SARS-CoV-2 to invade the lungs.

...

About RLF-100

RLF-100 (Aviptadil) is a patented formulation of Vasoactive Intestinal Polypeptide (VIP) that was developed based on Dr. Said's original work and was originally approved for human trials by the FDA in 2001 and the European Medicines Agency in 2005. VIP is primarily concentrated in the lung and is known to protect against a variety of lung injuries. VIP was awarded Orphan Drug Designation in 2001 by the U.S. FDA for treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension. The European Medicines Agency awarded orphan drug designation in 2006 for the treatment of acute lung injury and in 2007 for the treatment of sarcoidosis.

...

ALSO

 

RLF-100 (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE) (SAMICARE)

Brief Summary:

Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor.
https://clinicaltrials.gov/ct2/show/NCT04453839?term=aviptadil&draw=2&rank=3

 

3 Studies found for: Aviptadil
https://clinicaltrials.gov/ct2/results?term=Aviptadil&draw=2&rank=1#rowId0

[rxsid]

Some noteworthy articles in the news about RLF-100...

RLF-100 (aviptadil) clinical trial showed rapid recovery from respiratory failure and inhibition of coronavirus replication in human lung cells (August 2, 2020)

• - Rapid recovery of patients on ventilators and ECMO (extracorporeal membrane oxygenation) was seen in patients with severe medical comorbidities after three days of treatment with RLF-100 under FDA Emergency Use IND authorization at multiple clinical sites

• - Aviptadil is being developed as the first COVID therapeutic to block replication of the SARS-CoV-2 virus in human lung cells and monocytes

• - RLF-100 is a patented formulation of aviptadil (synthetic human Vasoactive Intestinal Polypeptide VIP), which has been granted FDA Fast Track Designation, FDA emergency use IND authorization, and an expanded access protocol

RADNOR, Pa. and GENEVA, Aug. 2, 2020 /PRNewswire/ -- NeuroRx, Inc. and Relief Therapeutics Holdings AG (SIX:RLF, OTC:RLFTF) "Relief" today announced that RLF-100 (aviptadil) showed rapid recovery from respiratory failure in the most critically ill patients with COVID-19. At the same time, independent researchers have reported that aviptadil blocked replication of the SARS coronavirus in human lung cells and monocytes.

RLF-100 has been granted Fast Track designation by FDA and is being developed as a Material Threat Medical Countermeasure in cooperation with the National Institutes of Health and other federal agencies. Further research will be conducted.

The first report of rapid clinical recovery under emergency use IND was posted by doctors from Houston Methodist Hospital. The report describes a 54-year-old man who developed COVID-19 while being treated for rejection of a double lung transplant and who came off a ventilator within four days.1 Similar results were subsequently seen in more than 15 patients treated under emergency use IND and an FDA expanded access protocol which is open to patients too ill to be admitted to the ongoing Phase 2/3 FDA trial.

Patients with Critical COVID-19 were seen to have a rapid clearing of classic pneumonitis findings on x-ray, accompanied by an improvement in blood oxygen and a 50% or greater average decrease in laboratory markers associated with COVID-19 inflammation.2

The clinical findings may be based on evidence that VIP inhibits the replication of the SARS-CoV-2 virus in human lung cells and immune cells (monocytes). The work was reported by Brazilian researchers working in a level-4 biocontainment laboratory.3 The same researchers reported a case-control study in which patients who survived being on ventilators for COVID-19 had significantly higher levels of VIP in their blood than those who died of respiratory failure.

"No other antiviral agent has demonstrated rapid recovery from viral infection and demonstrated laboratory inhibition of viral replication," said Prof. Jonathan Javitt, CEO and Chairman of NeuroRx. "We are conducting placebo-controlled trials to see whether the observations made in the case-control and open-label studies will be confirmed for less ill patients with COVID-19-related respiratory failure. Our independent Data Monitoring Committee will be conducting an interim analysis of these data later this month."

Others...

Rapid Recovery from COVID-19 Respiratory Failure after treatment with Vasoactive Intestinal Peptide

Relief, NeuroRx say emergency treatment with RLF-100 helps critically ill Covid patients [2]

Critically ill COVID-19 patients make quick recovery with treatment RLF-100

[rxsid]

This therapeutic looks promising for those that are most sick. This could be a perfect compliment to HCQ.

HCQ for prophylaxes and early disease stage, and Aviptadil for late disease stage.

[rxsid]

Ping!

The promising COVID therapy for respiratory failure few have heard of, but will soon - NeuroRx and Relief Therapeutics RLF-100 (Aviptadil)

[rxsid]

HCQ && Aviptadil == No "urgent" need for a vaccine.

[Presbyterian Reporter]

“””This therapeutic looks promising for those that are most sick. This could be a perfect compliment to HCQ.”””

---

Of course, this new stuff would not be needed if HCQ was readily available and prescribed as soon as a person was diagnosed as having covid.

In other words we don’t need the expensive new stuff if the cheap old stuff was used.

[Presbyterian Reporter]

A big contributor to ACT BLUE-—

ontributor information
Name EDISON, PAMELA
City and state CHEVY CHASE, MD, 20815
Occupation DRUG DEVELOPMENT
Employer NEURORX
Year to date $183.34
Contribution information
Amount $166.67
Receipt date October 2, 2018
Report year 2018
Memo EARMARKED FOR CASTEN FOR CONGRESS (C00648493)
Reported on Form 3X on line 11AI
Election type
Recipient information
Committee ACTBLUE
Political party
Type PAC with Non-Contribution Account - Qualified
State Massachusetts

[enumerated]

Best kept secret:

The actual treatment protocol for those testing positive for Covid19?

Nothing. Nada. Zip. Zero.

You get sent home and told to rest. Stay away from other people if you have symptoms. Maybe take a Tylenol to reduce any fever. Wait for it to go away on its own. That’s it.

Unless, that is, you are sick from something else. In which case, the treatment varies according to whatever other conditions you are suffering from.

Except in rare cases, Covid19 is not what is killing people - even those who happen to be infected with it when they die.

How rare is it to die with Covid19 as the primary cause? We simply can’t know, because there has been no attempt to gather data in a way that would allow that crucial statistic to be reported.

The CDC and Big Pharma doesn’t want people to know the true morbidity of Covid19, because it would be far, far less alarming than the all-inclusive morbidity number being reported.

The truth is that they want us to be alarmed, so we will comply with their guidelines. So we will line up for their mandatory $$$ vaccine when the time comes. These bureaucrats posing as scientists are just power-happy Statists who never met a government program or regulation they didn’t like. They never met a crisis they couldn’t profit from.

If they have their way, they would be dictating every aspect of our lives - a pandemic fear - a climate change fear - a gun violence fear - it doesn’t matter. Fear is just a means of justifying control. Tyrants always use fear to get people to trade away their liberties, and Covid is no different. They want us all obediently sucking on the government test and lining up for vaccines and chip implants.

If the true risk of death from Covid was known, everyone would have chucked their masks and gone back to work a long time ago.

[cmj328]

We’ll only hear about it if it provides money for well-connected people.

[Don Corleone]

My basic answer for all of these options is the same,”Follow the Money” Who is benefiting financially. Patients be damned. They are nothing but the advertising base for Big Pharma and ambitious politicians.

[LucyT]

.

PING

Check out Article and # 1, # 2.

Thanks, rxsid.

[CharlesWayneCT]

The U.S. life expectancy is currently around 78.24 years. The average age of death for a COVID “patient” is 78 years.

Sounds almost like people are dying about when we expect them to die, but some are dying with COVID.

[null and void]

Bring Out Your Dead

Post to me or FReep mail to be on/off the Bring Out Your Dead ping list.

The purpose of the “Bring Out Your Dead” ping list (formerly the “Ebola” ping list) is very early warning of emerging pandemics, as such it has a high false positive rate.

The false positive rate was 100%.

At some point we may well have a high mortality pandemic, and likely as not the “Bring Out Your Dead” threads will miss the beginning entirely.

*sigh* Such is life, and death...

If a quarantine saves just one child's or one old fart’s life, it's worth it.

[Jane Long]

Agree.

Great news...if so.

[musicman]

BTTT!!!

[WildHighlander57]

Bookmarking!!

[rxsid]

Actually, in this case, NeuroRx (the U.S. partner) is not "Big Pharma." In fact, it can hardly be considered "Little Pharma." It's a recent startup.[1]

[rxsid]

Yes, HCQ should be the initial answer for most.

However, it's not going to be 100% effective for 100% of Wuhan-19 patients. And for those that progress to serious complications, this therapy looks promising.

As for cost, it appears as though this too may be "relatively" cheap since it's a "generic" of something that occurs naturally and was identified decades ago. Ironically, almost analogous to HCQ (quinine derivative).

In part...

Vasoactive Intestinal Peptide (VIP) has been granted Fast Track Designation by FDA for the treatment of Critical COVID-19 with respiratory failure by FDA and has shown initial promise in FDA phase 2/3 clinical trials. Unfortunately, VIP has long been seen as an unattractive candidate for pharmaceutical development owing to its generic status as a natural peptide and its low cost of production, which limit its commercial potential and profitability. VIP may, however, be uniquely attractive from a global health perspective to combat the worst public health crisis since Spanish Flu killed more people than combat during World War I. VIP may also be the only candidate in human trials that could be produced at a cost structure that is compatible with the needs of the developing world.

Vasoactive Intestinal Peptide treats Respiratory Failure in COVID-19 by rescuing the Alveolar Type II cell (a pdf)

[sweetiepiezer]

Thanks for the ping.

Good news!

[gleeaikin]

Please, please remember that ZINC is an essential part of the HCQ treatment. Most people with co-morbidities are likely low on zinc and zinc (and other vitamins like C & D3) are quickly used up when Covid strikes. Zinc is like the soldiers going into combat, and the ionophore action of HCQ is like the landing craft carrying Zinc soldiers into the combat zone (inside the infected cell). Below is the best article I have seen regarding development and need for early treatment and especially zinc. It has 22 references, mostly scientific.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202847/

It appears that the way Covid kills is by making people severely deficient in major nutrients like zinc, Vitamins C, D3, and possibly E. What HCQ does is function as an ionophore to allow zinc into cells to kill/stop the virus which is trying to reproduce. If given early, there are not so many viruses that they overwhelm all the body systems. I would say that Covid-19 and many other pathogens attack and destroy nutrients. Co-morbidities especially are nutrient deficiency diseases. Self neglect is the crime, Covid is the executioner.

The cure is provide something that will attack Covid quickly before everything is depleted, and at the same time restore large amounts of the nutrients that are most critical. A few individual nutrients are being studied such as Vitamin C, but the interaction is complex and clinical trials are rarely set up for complexities. A hundred years of Allopathic medicine (drugs and surgery) have exceeded what they are good at. Now is the time for Natural Medicine to show what it can do. Dr. Zelenko’s protocol using early treatment, zinc, an ionophore, and an antibiotic seems quite effective. And it only costs $20 for 5 days. A good mix of vitamin and mineral supplements can be supplied for $1 a day. The new darling of the drug company world appears to be Remdesivir which it is suggested will cost from $1,000 to $4,000. Price not yet decided on.

[enumerated]

“Sounds almost like people are dying about when we expect them to die, but some are dying with COVID.”

I believe that is exactly what is happening. I can’t prove it, because data collection and reporting practices are simply not separating deaths according to their primary causes. There is no way to know the true death toll from Covid.

But they have done this deliberately so that no one can question their guidelines or weigh the economic costs of shutting down against the theoretical benefits.

They have deliberately muddied the waters all along - they want blind obedience.