Cell Therapy News/Articles, page-5626

There is a great article in the Wall Street Journal today in the "Opinion" section.
It is not just any other article.
Why? Because it was written by Kevin Kimberlin. Kevin was one of the founders of Osiris Therapeutics. So he knows what he is talking about.

@sheq posted a link to the Wall Street Journal article but since it is a subscription only service, it cannot be accessed unless you are a paid subscriber. But here is the same article published by the Regenerative Medicine Foundation:
https://www.regmedfoundation.org/2020/08/14/the-treatment-that-could-crush-covid/
I have pasted it here, just in case the link does not work or gets taken down:

NOTE: I have a few other notes after the article below, towards the end.

Here's the article:
The Treatment That Could Crush Covid
More than 500 clinical trials are under way world-wide in the race to find an effective treatment for Covid-19. Everybody wants it; nobody has it—yet. But one of the most promising therapies for Covid-19 patients uses “medicinal signaling cells,” or MSCs, which are found on blood vessels throughout the body.

In preliminary studies, these cells cut the death rate significantly, particularly in the sickest patients. With a powerful 1-2-3 punch, these cells eliminate the virus, calm the immune overreaction known as a cytokine storm, and repair damaged lung tissue—a combination offered by no other drug. This type of regenerative medicine could be as revolutionary as Jonas Salk’s polio vaccine.

In one pilot study in March, doctors at Mount Sinai Hospital in New York treated a dozen severely ill Covid-19 patients on ventilators with MSCs. Two infusions modulated their hyperactive immune systems, and 83% of those patients survived. With such promising results, the team at Mount Sinai and the supplier of the cells, Mesoblast Ltd., won Food and Drug Administration clearance and National Institutes of Health funding to conduct a randomized trial on 300 patients. The first patients in the trial received the treatment in early May.

A July 10 article in the Lancet reported on 13 critically ill Covid-19 patients also treated with MSCs. Eleven of the 13 patients lived—an 85% survival rate, which mirrors the results from Mount Sinai. The number of virus-fighting T-cells rose even as inflammation fell, suggesting that these cells can control the immune response as needed. In addition, chest X-rays showed that the drug repaired lung tissue, in some cases within 48 hours.

Healing tissue is essential because the cytokine battle with the Covid-19 virus is so vicious that it punches holes in the delicate lung membranes, allowing the virus to flood into the bloodstream and body cavities. These holes must be repaired, as virus leaks create some of the complications not usually associated with respiratory infections—blood clotting, heart attacks, stroke and multiple organ failure, which cause about 40% of Covid-19-related deaths. Blood-vessel density, and thereby the number of MSCs, decreases as we age, gain weight or develop diseases, which may explain why the elderly and those with chronic health conditions are faring worst.

In other words, this disease appears to be both a respiratory and a vascular infection. That is why the ability to fight infection, control the immune response and repair damaged tissue is such a valuable combination.

How can one drug do all this? MSCs were first identified and named by Prof. Arnold Caplan and colleagues at Case Western Reserve University in Ohio nearly 30 years ago. To translate this discovery into therapies, Mr. Caplan and I in 1993 launched Osiris Therapeutics, Inc. which developed this MSC into the world’s first approved systemically delivered cell therapy. During early years of scientific inquiry, Mr. Caplan and colleagues discovered that MSCs monitor and protect virtually every vessel in our bodies—the 60,000 miles of vessels that transport oxygen, nutrition and waste to and from every one of our cells.

When a MSC detects an infection or an injury to those vessels, it transforms into a factory to recruit and pump out immune-modulating and vessel-repair agents. These cells ameliorate crippling and deadly conditions when traditional chemical or biochemical drugs fail. The number of potential uses is enormous. MSCs are being tested on more than 900 different human ailments. Mr. Caplan describes these cells not as a “wonder drug,” but as a wonder drugstore.

Consider the results from trials conducted by Mesoblast on graft-versus-host Disease. Children with this horrible affliction suffer such a violent immune reaction that the skin and the lining of their intestines peel off. Up to 80% of children die if steroids don’t stop the inflammation. But in one trial, 160 of 239 patients (67%) who didn’t respond to steroids and other treatments survived after infusion with MSCs. Their cytokine storm disappeared. Injured tissues normalized. Based on these results, the FDA agreed to expedite its review and grant a decision by Sept. 30.

This is exactly the type of cell being tested for Covid-19 in the May trial. If the cells perform as they did at Mount Sinai in March and elsewhere, the results should be available before the end of September. A positive finding could help those most at risk of the disease’s worst effects. But the medical community and wider public are largely unaware of the potential for using MSCs to treat Covid.

Amid so much darkness, MSCs are a ray of hope—not only for the most desperate coronavirus patients, but all of us ready to end the pandemic and discover new ways to fix the body’s broken systems.

Other notes:
1) Besides Osiris Therapeutics, Kevin Kimberlin is also a founder of Myriad Genetics and Ciena Corp. He is currently the chair of Spencer Trask & Co., a Venture Capital firm https://spencertraskco.com/

2) As you may recall, I had spoken with Meredith Cowden's father, Gerald last week (on August 07) and he informed me that Meredith would be speaking at the ODAC. Well, she did (as those of you in Australia who stayed up to listen know).
I called them again today and expressed my deepest gratitude for all the noble work they have been doing in the GvHD area. Their foundation is called Meredith A . Cowden Foundation https://cowdenfoundation.org/
As @otherperspective proposed, we all should consider donating to that foundation.
I wrote about this in my Post #: 46393300
They partner with the Cleveland Clinic, University Hospitals Cleveland Medical Center, Case Western Reserve University, University of Pittsburgh Medical Center, BMT (Blood and Marrow Transplant) Infonet and National Bone Marrow Transplant Link and get funding from several sources, but additional donations would be welcome, I am sure.

Their work so far has been in the ADULT GvHD space and Gerald told me that they are keenly looking forward to working with Mesoblast for getting Ryoncil to be approved in the adult space.

3) Today's price action on the NASDAQ:
Price broke through the resistance of $16.01 and it is nothing but blue skies above. Even with the huge volume of shares traded (25+ million shares, which is the highest since the results of the EAP were announced on 04/24/2020), there was no accumulation. Would you believe that?
There definitely was distribution. So there was a lot of profit taking today.
Just imagine when there will be accumulation with this kind of huge volume (that would be a mind boggling share price rise). That day is coming. Yes. Early September. You know why.
Also, MACD just flipped to the positive side and RSI has a long way to go up. I expect the sp to continue its march upwards.

4) Even with the ODAC approval, MESO is still an unknown in the US. There are hardly any analyst articles compared to other biotechs. That is fine by me, since when the news barrage hits in September, the hounds will be let out. Flying under the radar is a good thing right now.

5) @chucke Thanks for your comments at the FDA/ODAC comments page. It is great to know that you were a School Teacher. Thank you for your service to the community. It is one of the noblest of professions. I have the utmost respect for Teachers (my Mom retired as one).

6) The American Heart Association (AHA) is concerned about heart damage from COVID-19:
"Initially thought to be an infection causing disease of the lungs, inflammation of the vascular system and injury to the heart appear to be common features of this novel coronavirus, occurring in 20% to 30% of hospitalized patients and contributing to 40% of deaths"
The EAP for MIS-C (Multisystem Inflammation Syndrome) in Children is using Remestemcel-L with one of the inclusion criteria related to heart damage "Participants must have demonstrable cardiac involvement (reduced left ventricular [LV] ejection fraction ≤50%)".
As I said many times recently, Remestemcel-L looks like it will be a panacea for all conditions related to inflammation. Expect huge things coming out of the EAP. Remestemcel-L is not for COVID-19 ARDS anymore.
Here's the AHA related article:
https://newsroom.heart.org/news/severe-covid-19-associated-with-heart-issues-much-yet-to-discover-an-american-heart-association-overview

7) @vasilios You said you don't have a problem with shorts. Well, let me tell you that you are the type who enjoys seeing a home on fire so that you can buy it on the cheap. I hate shorts. And I despise your patronizing, telling me not to worry about the recent short attack. And no, you don't need to respond back to me, if you are thinking about it.

Have a good weekend folks. Stay safe.