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  The Herman Trend Alert

February 17, 2021

Therapies and Cures for COVID-19

All of us are more than exhausted from the rigors of keeping ourselves safe from the SARS CoV-2 virus. Having effective therapeutics and perhaps even actual cures before the planet achieves herd immunity will be a game changer. This Herman Trend Alert will briefly cover the treatments used around the world, then discuss the new drugs already in trials andĘshowing success in Israel.

Treatments in the United States and Elsewhere
According to the US Centers for Disease Control, the country's Food and Drug Administration (FDA) has approved only one pharmaceutical, Remdesivir (Veklury), to treat COVID-19 and then only in certain situations; it has also been okayed in Japan and Australia. In other countries, other drugs have been approved: Dexamethasone in the United Kingdom and Japan; Avigan (favilavir) in China, Italy, and Russia. In addition, in the US, the emergency use of Convalescent plasma was authorized by the FDA in August 2020.

A Promising Cure for COVID-19?
Under ordinary circumstances, I would dismiss a sample size of 30 without a second thought. However, we are living in extraordinary times, and the infection in question is COVID-19. This one experimental medication which to date have been 100 percent effective in curing 30 patients with mild to severe cases of the infection and another which shows promise. Developed in Israel, EXO-CD24 has recently completed Phase I clinical trials at a local hospital.

An Inhaled Drug: EXO-CD24
Since the lungs are where the SARS-CoV-2 virus lives in the body, an inhaled medication makes a lot of sense. Developed at Tel Aviv Sourasky Medical Center, EXOCD24 stops the "cytokine storm," first mentioned in a Herman Trend Alert last year. In that circumstance, the uncontrolled immune system begins attacking healthy cells. Sadly, that condition occurs in the lungs of 5 to 7 percent of COVID-19 patients. In 29 of the 30 cases, medical conditions improved in only 2 to 3 days and most of them were sent home within 3 to 5 days. The 30th patient also recovered but after a longer time.

How EXO-CD24 Works
The medication is based on cell elements called "exosomes," used for intercellular communication, that are released from the cell membrane. The researchers enrich the exosomes with a protein called "CD24." Emitted on the surface of the cell, this protein has a known and important role in regulating the immune system. One of the Israeli scientists Professor Nadir Arber has been researching the role of the CD24 protein for over 20 years. The formulation is given by inhalation, once a day, for five days---for only a short while each day.

What is Special about EXO-CD24
The experimental treatment has two unique characteristics. First, it inhibits the over-secretion of cytokines, and second, it is delivered directly to the lungs eliminating the systemic side effects that injected or oral drugs sometimes cause. Moreover, the formulation of this advanced preparation can be produced quickly and efficiently and even better, at a very low cost in any pharmaceutical facility in any country. Now EXO-CD24 is ready for Phase II trials.

Another Possible Cure Already in Phase II
Meanwhile, not long ago elsewhere in Israel, Enlivex Therapeutics reported positive results from a multi-center Phase II clinical trial of its experimental COVID-19 immunotherapy drug called "Allocetra" for treatment of severe and critical patients. Unfortunately, their sample sizes are even smaller.

Allocetra's Impressive Results
In October, five COVID-19 intensive care patients were discharged from the Hadassah University Medical Center in Jerusalem after treatment with Allocetra. A total of 9 severe and 7 critical COVID-19 patients were treated with the drug in their Phase II clinical trial. Remarkably, 14 of the patients recovered and were discharged from the hospital after an average of 5.3 days. Originally, this Phase II trial was expected to enroll 24 patients but was "completed early" to fast-track regulatory filings of the trial's positive safety and efficacy data. All told, 19 of the 21 patients in Allocetra's Phase II and Phase Ib trial recovered and were discharged from the hospital after an average of 5.6 days.

It Even Worked with Patients with Additional Risk Factors
Even more notable was that most of the patients in both studies had pre-existing risk factors like male gender, obesity and hypertension. And now, weeks or months later, their Phase II patients who have been discharged from the hospital are currently healthy. These Enlivex researchers believe that the pharmaceutical's compelling results" have demonstrated the safety and efficacy of Allocetra even in these more complicated patients in severe and critical stages of the disease.

Given the limited number of therapeutics and treatments we have in our COVID-19 arsenal, these two Israeli medications will be welcome additions.

To read the original article in Israel 21c, visit here.

On a brief personal note: we human beings take for granted many of the modern conveniences. When, for 20 hours this week, my husband and I were without electricity and heat, I came to understand how spoiled we have become. Most of our home was about 50 degrees Fahrenheit. I learned a lot. For that 20 hours, a large percentage of my time was spent strategizing about how to stay warm, safe, and fed. The temperature is once again below freezing. As I send this Trend Alert to you, we are now without water; I spent the afternoon melting snow and collecting water dripping from the roof. I hope that you, dear readers, never need to learn these lessons the way we did. Stay warm; stay safe. Wear a mask and stay away from crowds; we are not out of the woods yet.

Next Week's Herman Trend Alert: AI Solution for Developing Employees
Last week, my podcast partner, Ira Wolfe and I had the pleasure of interviewing Jason Cochran of iAspire and Dulead. Next week's alert will be a deep dive into how this innovative product works and what it could mean to your organization---now and in the future.

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At this season of Thanksgiving in the United States, I wanted to take the opportunity to express my appreciation to you, our valued subscribers for your continued loyalty. It is precisely that loyalty that allows me to come into your lives once a week with our insights and forecasts for the future. Many thanks!

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