Enlivex Reports Positive Top-Line Results from Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients and Provides a Program Update

https://www.globenewswire.com/…des-a-Program-Update.html

Phase II (16 patients treated, 9/16 (56%) with severe illness, 7/16 (44%) with critical illness, follow-up period of 28 days post-AllocetraTM treatment)

0/16 (0%) mortality on day-28

14/16 (87.5%) patients recovered and were discharged from the hospital by day-28

Average duration of hospitalization post administration of AllocetraTM for discharged patients was 5.3 days

2/16 (12.5%) patients, both of whom had critical illness at the time of AllocetraTM treatment, were hospitalized in the ICU on a respirator on day-28

Phase II + Ib (21 patients treated, 11/21 (52%) with severe illness, 10/21 (48%) with critical illness)

0/21 (0%) mortality on day-28

19/21 (90.5%) patients recovered and were discharged from the hospital by day-28

Average duration of hospitalization post administration of AllocetraTM for discharged patients was 5.6 days

2/21 (9.5%) patients, both of whom had critical illness at the time of AllocetraTM treatment, were hospitalized in the ICU on a respirator on day-28

Based on the positive safety and efficacy results from the Phase II trial and in consultation with the trial’s principal investigator, the Company has completed the Phase II trial early after enrolling sixteen, rather than twenty-four, patients. The Company expects to submit a summary of the data to regulatory bodies later this month to serve as the basis for a discussion on the next steps in Allocetra’s regulatory pathway in COVID-19 patients with severe or critical illness.

Allocetra’s intrinsic mechanism of action is immune-modulation, and is expected to potentially be relevant to COVID-19 severe/critical patients infected by various coronavirus strain mutations

Nes Ziona, Israel, Feb. 03, 2021 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today reported positive top-line results from a multi-center, investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. Based on the positive results and in consultation with the trial’s principal investigator, the Company has completed the trial early and plans to submit a summary of the data for review by the relevant regulatory bodies. Submission of the data summary to regulators is expected later this month and will serve as the basis for a discussion with regulators on the next steps in Allocetra’s regulatory pathway in COVID-19 patients with severe or critical illness.

Sixteen COVID-19 patients were treated with AllocetraTM in the Phase II clinical trial, which originally was expected to enroll twenty-four patients. The clinical trial was completed early in support of anticipated accelerated regulatory filings of the trial’s positive safety and efficacy data. Of the sixteen patients enrolled in the Phase II trial, nine (9/16, 56%) were in severe condition and seven (7/16, 44%) were in critical condition.

Quote from Fm1

With the ongoing pandemic, none of this would be out of the ordinary except for the fact that Michael has received both doses of his COVID-19 vaccine. His first Pfizer shot was Dec. 28, followed by a second one Jan. 18.

That is not far out of the ordinary either. When you expose people who have received both doses to the virus, 5% of them will be infected (compared to unvaccinated people). It is likely they will have a mild case. It is very unlikely they will die, but there is still some risk. So, even after you get both doses, you should wear a mask and be careful. When a large fraction of the population has been vaccinated, the virus will become rare or extinct, and we can all stop wearing masks.

https://www.nytimes.com/2021/0…-coronavirus-vaccine.html

Could a Single Vaccine Work Against All Coronaviruses?

Scientists are working on a shot that could protect against Covid-19, its variants, certain seasonal colds — and the next coronavirus pandemic.

Quote from Alan Smith

Johannesburg - The Pharmaceutical Society of SA (PSSA) believes the Gauteng High Court ruling to allow doctors to use ivermectin to treat Covid-19 patients was influenced by social media.

The organisation’s manager Ivan Kotze said the court verdict showed the power of social media because people used the platform to call on SA Health Products Regulatory Authority (SAHPRA) to approve the drug.

Apparently the courts and regulators in South Africa have more power over doctors than in the U.S. As I have pointed out before, the FDA cannot forbid doctors from using ivermectin or any other approved drug. This is called "off label" use. If the doctor harms or kills the patient with an overdose, that would violate FDA rules. That would also violate the rules if the drug was used for the original intended purpose.

Quote from Alan Smith

https://www.iol.co.za/pretoria…59-4abe-a278-2e2aeabef9dd

Johannesburg - The Pharmaceutical Society of SA (PSSA) believes the Gauteng High Court ruling to allow doctors to use ivermectin to treat Covid-19 patients was influenced by social media.

The organisation’s manager Ivan Kotze said the court verdict showed the power of social media because people used the platform to call on SA Health Products Regulatory Authority (SAHPRA) to approve the drug.

On Tuesday, the high court issued an order by agreement with the SAHPRA, to allow doctors to start ivermectin treatment.

This gave doctors the nod to start ivermectin treatment concurrently with the submission of an article 21 application, in cases where the doctor deems urgent access to ivermectin as crucial for a patient.

SAHPRA previously said ivermectin was not indicated nor approved for use in humans. It said there was no confirmatory data on ivermectin available as yet for its use in the management of Covid-19 infections. In terms of safety and efficiency, there was no evidence to support the use of ivermectin.

Kotze said he supported the decision by SAHPRA.

“The ivermectin studies that were used by the doctors were not real studies and we can’t rely on them to be effective. These studies need to be scientifically proven. Remember the pharmacies are businesses and they want to make profit,” Kotze cautioned.

“If anything goes wrong the public should launch complaints against those health professionals.”

SA Medical Association (Sama) spokesperson Dr Mvuyisi Mzukwa said they were not sure what the clinical impact of ivermectin would be.

“The evidence for the effectiveness and adverse effects of ivermectin in patients severely ill with Covid-19 is still very unclear, and larger potentially more convincing trials have yet to be completed.

“SAHPRA had recommended that doctors wait until the evidence is better before recommending this to patients. Now it is allowing access while trying to gather better evidence of effects and side effects in patients,” said Mzukwa.

Department of Health and SAHPRA spokespeople Popo Maja and Yuven Gounden did not respond to questions sent by the Sunday Independent on Wednesday.

However, on Wednesday SAHPRA released a statement refuting claims that the regulator had “buckled under pressure” as a consequence of the court action brought by, among others the AfriForum regarding access to ivermectin.

SAHPRA said this was not the case. “The court deliberations of February 2, 2021 culminated in an order that reiterates the position that SAHPRA communicated on 27 January 2021. In other words, SAHPRA’s programme of controlled compassionate use of Ivermectin remains firmly in place, said CEO Boitumelo Semete-Makokotlela.

“The culmination of the many engagements was the decision to implement the Programme. This move was announced at the media briefing held on 27 January 2021. SAHPRA’s timing and the action brought on by Afriforum is a mere coincidence,” said Semete-Makokotlela.

However, the Independent Community Pharmacy Association of SA (ICPA) spokesperson Jackie Maimin welcomed the ruling in favour of allowing the use of ivermectin.

“The programme also allows health establishments such as hospitals and pharmacies to hold bulk stock of ivermectin for emergency use.

Doctors and patients using ivermectin sourced under a section 21 can take comfort that the medicine is a registered medicine manufactured by a reputable company under strict quality-controlled conditions and that the medicine was manufactured for human consumption.

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Using a gene therapy in an experimental fashion borders on mandatory and safe, but Ivermectin approval is "social media" and driven by "buckling". You have to admit, the media is good at is job - disinformation and mind-control.

Any theory on why people massively test positive after receiving a vaccine?

https://www.haaretz.com/israel…st-vaccine-shot-1.9462478

Maybe because the vaccine doesn’t immunize you from Covid-19 or any of its variants.?

Maybe big Pharma the media have sprinkled the word vaccine around to liberally because that’s what the public wants to hear?

Quote from Navid

Any theory on why people massively test positive after receiving a vaccine?

It is obvious. First, the numbers are not "massive." It says the number is 6.6% of the 189,000 who were vaccinated. That is less than the unvaccinated population for the same period. It is in line with the initial protection from the first dose. And it expected because many people were infected before they were vaccinated, or up to 12 days after vaccination. The blind tests showed that first does does not have a measurable effect before 12 days. The number of people infected after the second dose was 69, which is 0.04%. After adjusting for the number of expected infections, that is in line with the estimated 95% effectiveness rate.

Here is a more accurate analysis:

https://www.nytimes.com/2021/0…israels-vaccine-data.html

Israel’s Early Vaccine Data Offers Hope

Initial studies show a significant drop in infections and hospitalizations after just one dose, and very few cases after two. Experts caution that the results are preliminary.

cases of MIS-C are rising all across middle America, long Covid will drain resources meant for other disease. The US and the world must adopt early treatment now or this will go on for the foreseeable future.

IU Health seeing spike in syndrome linked to COVID-19 that is attacking children and teens

https://fox59.com/news/iu-heal…g-children-and-teens/amp/

Doctors at Indiana University (IU) Health are seeing a spike in a syndrome linked to the coronavirus. This illness is targeting children and teens.

“It’s tough to know which kids are going to come down with it, and that’s one of the research questions trying to be answered,” explains Samina Bhumbra, IU Health assistant professor of clinical pediatrics, “It was just described in late April, May of 2020, so it still a fairly new syndrome.”

It’s called multisystem inflammatory syndrome in children, or MIS-C. It is similar to Kawasaki disease, and comes after a child has recovered from COVID-19. Like Kawasaki, a patient will come down with a high fever, and can show signs of a rash. They differ in that MIS-C will impact the stomach and can strike in children all the way through teens.

There are cases of adults getting it in their 20s or 30s, but then it’s not called MIS-C, it’s called MIS-A. A being for adults,” details Bhumbra.

IU health says overall the syndrome is rare compared to the total number of children contracting COVID, however they have seen 30 cases since late December.

“Fevers are the big thing, certainly fevers that last three days in a row, and aren’t responding well to Tylenol or ibuprofen,” says Bhumbra.

If your child recently got over the coronavirus and is showing signs of fever with stomach pains, you are urged to contact a hospital emergency room or your primary care physician. MIS-C can be treated with medications.

Quote from Alan Smith

“The ivermectin studies that were used by the doctors were not real studies and we can’t rely on them to be effective. These studies need to be scientifically proven. Remember the pharmacies are businesses and they want to make profit,” Kotze cautioned.

“If anything goes wrong the public should launch complaints against those health professionals.”

SA Medical Association (Sama) spokesperson Dr Mvuyisi Mzukwa said they were not sure what the clinical impact of ivermectin would be.

“The evidence for the effectiveness and adverse effects of ivermectin in patients severely ill with Covid-19 is still very unclear, and larger potentially more convincing trials have yet to be completed.

This tells how far reaching the world wide mafia action is. Exact same wording used everywhere. Co complete nonsense arguments that applied to other drugs would forbid to use most of them...

Quote from Navid

Any theory on why people massively test positive after receiving a vaccine?

I mentioned it some posts ago: During the two weeks after the first Pfizer shot your risk to get CoV-19 is increased by 2x! This fact has been cheated away by Pfizer in the Phase III study and now clearly shines up also in the Israel statistics!

Israel still sees no change in infection/death rate despite > 20% had two shots. Other countries have much better data without vaccination. So it will be very difficult to get the real answer soon about how well vaccines work.

Do not forget that the vaccine test has not been done among people in lock down and not among isolated people in care homes!

Quote from JedRothwell

It says the number is 6.6% of the 189,000 who were vaccinated.

How much more nonsense are you going to spread?? 6.6% of Israel is 600'000 people this would be at bit less cases within 2 months than the current total...

Buy a pocket calculator before the next post!

New coronavirus closely linked to SARS-CoV-2 is discovered in bats in Thailand - and their antibodies can neutralise the pandemic virus

https://www.dailymail.co.uk/sc…overed-bats-Thailand.html

A coronavirus related to the one causing the global pandemic has been discovered in the blood of five bats living in Thailand.

SARS-CoV-2, the virus which causes Covid-19, shares 91.5 per cent of its genetic code with that of the newly-identified virus, called RacCS203

However, antibodies circulating in the blood of infected bats and pangolins were found to be effective at neutralising the SARS-CoV-2 virus.

This biological paradox indicates bat-based coronaviruses can not, as standard, infect humans, experts speculate.

The authors instead think coronaviruses only evolve the ability to infect human cells after first being passed into an intermediate host, such as a pangolin.

Here, it mutates and changes shape slightly which gives it the ACE2-binding facility, the authors theorise.

These findings align with yesterday's announcement from the World Health Organization that the pandemic likely emerged naturally and the coronavirus was not released from a laboratory.

Researchers led by Chulalongkorn University in Bangkok took samples from bats in a wildlife sanctuary in Eastern Thailand.

They conducted genomic sequencing on the new virus to discover how closely-related it was to other coronaviruses, including SARS-CoV-2.

It revealed the new virus's closest relative is called RmYN02, a virus which is 93.6 per cent identical to SARS-CoV-2.

While genetically similar (91.5 per cent identical), SARS-CoV-2 and RacCS203 — the new virus — have key differences.

For example, although the spike proteins of the two viruses are genetically similar, a key region on the spikes which binds to the human receptors is very different in shape, making it impossible for the new virus to bind to human ACE2 cells.

The discovery of the new virus adds to a growing bank of knowledge about the family of coronaviruses to which SARS-CoV-2 belongs.

Previously, similar viruses had only been found in China and Japan, but the presence of this strain in Thailand indicates there are far more than previously believed, likely spread over a 3,000 mile range across Southeast Asia.

Covid-19 hyperinflammation and post-Covid-19 illness may be rooted in mast cell activation syndrome

https://www.sciencedirect.com/…cle/pii/S1201971220307323

Abstract

Objectives

One-fifth of Covid-19 patients suffer a severe course of Covid-19 infection; however, the specific causes remain unclear. Mast cells (MCs) are activated by SARS-CoV-2. Although only recently recognized, MC activation syndrome (MCAS), usually due to acquired MC clonality, is a chronic multisystem disorder with inflammatory and allergic themes, and an estimated prevalence of 17%. This paper describes a novel conjecture explaining how MCAS might cause a propensity for severe acute Covid-19 infection and chronic post-Covid-19 illnesses.

Methods

Observations of Covid-19 illness in patients with/without MCAS were compared with extensive clinical experience with MCAS.

Results

The prevalence of MCAS is similar to that of severe cases within the Covid-19-infected population. Much of Covid-19’s hyperinflammation is concordant with manners of inflammation which MC activation can drive. Drugs with activity against MCs or their mediators have preliminarily been observed to be helpful in Covid-19 patients. None of the authors’ treated MCAS patients with Covid-19 suffered severe infection, let alone mortality.

Conclusions

Hyperinflammatory cytokine storms in many severely symptomatic Covid-19 patients may be rooted in an atypical response to SARS-CoV-2 by the dysfunctional MCs of MCAS rather than a normal response by normal MCs. If proven, this theory has significant therapeutic and prognostic implications.

SARS-CoV-2 Infection Prevented and Treated in Human Lung Tissue Model

https://www.genengnews.com/new…-human-lung-tissue-model/

Given the steady numbers of new COVID-19 cases, the appearance of new variants, and the considerable time that vaccinations will take to reach target levels needed for herd immunity, the development of treatments and useful therapeutics remains a top priority. In particular, treatments and preventive approaches that can be widely and rapidly implemented are urgently needed to curb the risk for COVID-19 related hospitalization and death in multiple settings including nursing homes and long-term care facilities.

Now, scientists at UNC have found that the orally administered experimental drug EIDD-2801 (now known as molnupiravir or MK-4482) halts SARS-CoV-2 replication and prevents infection of human cells in a new in vivo lab model containing human lung tissue. Separate Phase II and III clinical trials are ongoing to evaluate molnupiravir safety in humans and its effect on viral shedding in COVID-19 patients, and the first results could be released as early as March.

This work is published in Nature in the paper titled, “SARS-CoV-2 infection is effectively treated and prevented by EIDD-2801.”

Molnupiravir is being developed by Merck & Co. in collaboration with Ridgeback Therapeutics.

Mouse models can be useful in studying highly pathogenic human coronaviruses including SARS-CoV-2 and compounds that might control infection. But human coronaviruses do not replicate in mice unless researchers alter the virus, genetically modify the mice, or introduce the individual human receptor genes into mice so the virus can infect cells. Such mouse models have added to the scientific community’s understanding of coronavirus infection and disease progression, but none of these models possess the diverse human cells found in human lungs where viral infection can cause severe disease. UNC scientists created a solution to this problem—a line of mice with human lung tissue that includes all the primary human cells infected when individuals fall ill with COVID-19.

Quote from Fm1

Molnupiravir is being developed by Merck & Co. in collaboration with Ridgeback Therapeutics.

$$$$$$ instead of cents for Ivermectin.....

Quote from Fm1

It revealed the new virus's closest relative is called RmYN02, a virus which is 93.6 per cent identical to SARS-CoV-2.

This is the problem: 2000 mutations distance times 2 weeks for one and a miracle chain of 2000 hosts all doing the correct mutation and survive...

Solution: Next week: Mink identified for being source of Corona virus. Found in an old fur in the Himalaya...

The antibody response to SARS-CoV-2 increases over 5 months in patients with anosmia/dysgeusia

https://www.medrxiv.org/conten…2.05.21251219v1.full-text

Abstract

The factors involved in the persistence of antibodies to SARS-CoV-2 are unknown. We evaluated the antibody response to SARS-CoV-2 in personnel from 10 healthcare facilities and its association with individuals’ characteristics and COVID-19 symptoms in an observational study. We enrolled 4735 subjects (corresponding to 80% of all personnel) over a period of 5 months when the spreading of the virus was drastically reduced. For each participant, we determined the rate of antibody increase or decrease over time in relation to 93 features analyzed in univariate and multivariate analyses through a machine learning approach. In individuals positive for IgG (≥ 12 AU/mL) at the beginning of the study, we found an increase [p= 0.0002] in antibody response in symptomatic subjects, particularly with anosmia/dysgeusia (OR 2.75, 95% CI 1.753 – 4.301), in a multivariate logistic regression analysis. This may be linked to the persistence of SARS-CoV-2 in the olfactory bulb.

Introduction

It is becoming clear that the antibody response to SARS-CoV-2 can last at least 6 months in symptomatic patients 1, but it seems to decline in asymptomatics 2. Similarly, a reduction of antibody response in asymptomatic individuals was shown in a study with a fewer number of individuals (n = 37) 3. The antibody response in COVID-19 patients is associated with the establishment of a memory B cell response which is higher at 6 months 1, however, it is not clear whether there are features that correlate with this sustained B cell response. We previously showed that an anti-SARS-CoV-2 serological analysis allowed us to follow the diffusion of the virus within healthcare facilities in areas differently hit by the virus 4. At 5 months of distance, we analyzed the duration of this antibody response and evaluated whether there were features correlating with maintenance, reduction or increase of the antibody response.

Results

We assessed the correlation of the rate of antibody increase or decrease with the different analyzed features. In Tables 1 and 2 are reported the rates for individual classes of features with relative statistical analysis. As shown, in the 5 months of observation, females sustained the antibody response better than males (p = 0.01); similarly non-medical healthcare professionals (specifically, healthcare partner operators) had higher antibody rates (p = 0.0009). The levels of antibodies increased in hospitals located in the Bergamo area (Castelli and Gavazzeni p < 0.0001) (Table 1) which was more hit by COVID-19 (37 – 43% of individuals with IgG ≥ 12)7. More important, the IgG rate in individuals which were positive for IgG (IgG ≥ 12 AU/mL; n = 613) at the beginning of the study was increased (p<0.000001) over time, and this increase was either minor in asymptomatics (n = 91, p = 0.00003) and paucisymptomatics (n = 203) or strong in symptomatics (n = 319, p = 0.0006) (Table 2). On the contrary, those that had an intermediate IgG titer (3.8 < IgG < 12 AU/mL considered as negative) displayed all a significant reduction in IgG rate (p < 0.000001) (Table 1). This may be due to a noise in test analysis as these subjects are considered as negative for SARS-CoV-2 IgG according to manufacturer. Many symptoms, including fever, cough, muscle pain, asthenia, tachycardia and anosmia/dysgeusia, correlated with an increase of antibodies in the 5-month observation period (Table 2).

Quote from Fm1

The antibody response to SARS-CoV-2 increases over 5 months in patients with anosmia/dysgeusia

https://www.medrxiv.org/conten…2.05.21251219v1.full-text

One thing is interesting among the age groups: Those who faced a strong flue during their child live had higher antbodies than others. Seems to be important not to vaccinate children against flu!

Quote from Wyttenbach

One thing is interesting among the age groups: Those who faced a strong flue during their child live had higher antbodies than others. Seems to be important not to vaccinate children against flu!

The best thing that can happen is more eyes on this industry, they will not be able to escape with no questions asked anymore.

Where did you see the flu vac stats? I didnt find that

Theoretically, we know that flu vaccines which are inactivated preferentially setup the system for TH2 response, more inflammation, and more antibodies.