Posted on 04/20/2020 10:24:38 PM PDT by SeekAndFind
Pluristem Therapeutics (PSTI), a small Israeli biotech provided promising preliminary data regarding a possible COVID-19 treatment.
Last week, Pluristem released initial results from its compassionate use program for the treatment of patients with acute respiratory failure and inflammatory complications resulting from COVID-19. Specifically, all seven ICU patients with acute respiratory distress syndrome (ARDS) treated so far with Pluristem’s PLX cell therapy have survived, with 6 out of 7 having completed the seven-day follow-up (one is still within the period). 4 out of the 6 (66%) patients displayed improvement in respiratory parameters, and 3 of the 6 (50%) patients are in late stages of weaning from ventilators.
Next up, the company will apply to commence a multinational clinical study to further explore the potential use of PLX cells in the treatment of patients suffering from complications linked to COVID-19. PLX cells are allogeneic mesenchymal-like cells with immunomodulatory properties and can possibly suppress or reverse the risky over-activation of the immune system.
H.C. Wainwright’s Swayampakula Ramakanth is “very encouraged” by the results and believes “the use of PLX cells for the treatment of COVID-19 could become a significant upside for the company.”
The analyst added, “In our view, with the ongoing pandemic affecting nearly every country and stressing healthcare systems around the world, new, effective treatments are urgently needed. Therefore, we believe that both the FDA and the EMA may expedite the approval for clinical studies and simply the regulatory paths going forward. With regulatory expediency and patients only needing a 28-day follow-up, we believe the company could complete the initial studies and report results in 2H20.”
(Excerpt) Read more at finance.yahoo.com ...
MORE HERE FROM THE TIMES OF ISRAEL:
Israeli scientists who claim a single placenta can treat 20,000 coronavirus sufferers are hopeful after beginning the treatment, as some of its first patients have shown improvement while their company’s shares have skyrocketed.
Pluristem Therapeutics uses placentas to grow smart cells, and programs them to secrete therapeutic proteins in the bodies of sick people. It has just treated its first American COVID-19 patient after treating seven Israelis.
There is no follow-up data on the American patient, but the company reported that as of a follow-up on April 7, all seven Israelis had survived and three were on target to soon move off ventilators, while one had shown deterioration in respiratory parameters.
Two of the four Israelis with multiple organ failure showed clinical recovery as well as respiratory improvement. All patients were one week after treatment at time of follow-up, apart from one, who received treatment after the others and whose health update wasn’t reported.
The treatment of select patients doesn’t constitute a clinical trial and there is no control group, but company CEO and president Yaky Yanay said Thursday that a trial will come soon and, once conducted, he hopes that “approval can be very fast.” Upon receiving the green light from regulators, he said, massive quantities of treatment can be prepared. “We can manufacture cells to treat thousands very quickly,” he said.
The market appears to share his optimism. For most of 2020 shares have traded at under $4; now the price is close to $10.
But public health expert Manfred Green said he is “very very cautious” about such innovations. Green, founding director of the Israel Center for Disease Control and director of the University of Haifa’s international masters program in public health, said: “I don’t have any feeling this is going to work. This is a viral disease, not something from outer space, and for viral diseases we’ve always struggled to find treatment.”
Yanay said that his innovation will save lives, both by improving the health of critical patients, and by freeing up space in intensive care units for others.
“I think this will have a huge impact because currently the battle is in the ICUs,” he said. “We need to take people off ventilation machines and get them out of ICUs.”
The treatment is waiting on regulatory approval, but Pluristem is receiving approvals on a patient-by-patient basis in Israel and the US, hoping to gather enough information for full approval. In Israel it has worked so far at three hospitals under a compassionate use program, and at Holy Name Medical Center in New Jersey it was allowed to administer cells under the Coronavirus Treatment Acceleration Program, an emergency mechanism for possible therapies.
Treatment consists of 15-milliliter doses of cells — known as PLacental eXpanded cells — administered in simple inter-muscular injections. Once in the body, Yanay said that the cells become like “a small factory that generates therapeutic proteins.”
He explained: “Most drugs we know are administered in the quantity we need, but this is a ‘drug’ that can sense the human body’s environment, and based on the signals that the cells receive from the body, they secrete therapeutic proteins that push the body toward regeneration.”
The cells secrete two types of proteins. One reduces inflammation; the other is to regulate the immune system. Yanay hopes these so-called immunomodulation proteins can slam the brakes on the immune system to stop it turning on itself, as commonly happens with critical coronavirus patients.
“They stop the body from attacking its own organs by having the placenta cells secrete immunomodulatory factors, basically relaxing the immune system, as the other proteins reduce inflammation,” said Yanay.
He elaborated: “Patients who are in severe condition and dying are actually dying from a severe respiratory condition. What is actually happening is there is a very high level of inflammation and at a certain point the immune system of the patient will attack [the patient], mostly in the lungs.”
Until now, Pluristem’s technology has been largely used to treat people suffering from poor blood flow to the legs, but the company’s scientists were able to quickly repurpose the cells to treat coronavirus patients.
“We take cells from the placenta after full-term delivery and we have developed technology to expand the cells to very large numbers, in an environment that mimics the human body,” Yanay said. “The technology allows us to treat more than 20,000 people from a single placenta.”
His team “programs” the cells, which then have a wide range of proteins they can secrete. The cells don’t just deliver the proteins but also “adjust the level of secretion based on signals they receive from the body,” he said.
Yanay stated that Pluristem, which is based in Haifa, will carry on treating people using patient-by-patient approvals, while working as quickly as possible for full approval by regulators.
“We are receiving many inquiries and requests for treatment from health care providers and families worldwide,” he said. “In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries.
“Our main focus remains, however, the initiation of a multinational clinical study,” he said, adding that he was hopeful “cell therapy is a very good candidate to tackle a complex disease that is attacking several organs.”
MORE HERE:
First US Patient Tested With Israeli COVID-19 Treatment That Claims to Produce 100% Survival Rate
An Israeli Coronavirus treatment that successfully cured seven severely ill patients in Israel tested the first US patient.
The US treatment was authorized under the US Food and Drug Administration’s Single Patient Expanded Access Program, which is part of the US Coronavirus Treatment Acceleration Program. This is an emergency program dedicated to treating coronavirus patients as quickly as possible
The US patient was treated at Holy Name Medical Center in New Jersey with the company’s PLX cell therapy. Pluristem is already running a Phase III critical limb ischemia study. Similar to patients treated in Israel, this patient was critically ill with respiratory failure due to acute respiratory distress syndrome and was intubated in an intensive care unit for three weeks.
Pluristem Therapeutics uses placentas to grow smart cells, and programs them to secrete therapeutic proteins in the bodies of sick patients. Pluristem Therapeutics Inc, a biotech company, based in Haifa, reported that they applied their treatment to seven Israeli patients who had a severe respiratory failure, and they have survived.
According to the Jerusalem Post, “The patients were approved for treatment under the compassionate use program and exhibited respiratory failure requiring intubation in the ICU. Four of the patients had multi-system organ failure, including heart and kidney failure.”
“The seven patients were treated with Pluristem’s allogeneic placental expanded (PLX) cells. Essentially, these cells can potentially suppress or reverse the dangerous over-activation of the immune system that causes death in many coronavirus patients. All seven of the patients who received the drug survived and four patients saw an improvement in respiration. One patient is still alive but saw a continued deterioration of their respiratory system.”
Pluristem is concentrating on conducting a multinational clinical study and on expanding compassionate use in other countries as well.
Pluristem CEO and President, Yaky Yanay, stated, “We are pleased with this initial outcome of the compassionate use program, and committed to harnessing PLX cells for the benefit of patients and healthcare systems. In order to maximize PLX cells’ impact on patient recovery and to work towards making our treatment widely available, we plan to quickly move forward into a clinical development program.”
Meanwhile, the company’s stock price skyrocketed; the price has more than doubled in a short time. Which presents high expectations for this Israeli COVID-19 treatment.
There is a sstem which preserves the placentas of some births, in anticipation of using the cells for future treatments. I wonder if the placentas this program uses needs be fresh?
this sounds quite promising ... and an intelligent way of dealing with how the virus works
however, it will still require at least one protocol clinical study before it will be used on a wider, public basis
If you remember some years back there was a group that was doing research that was kind of goofy. They claimed they were injecting pleuripotential stem cells that had been “targeted” to atheromamtous lesions of the coronary arteries and this was going to usher in an entirely new way of treating ischemic coronary heart disease. I was somewhat interested because my daughter was getting her PhD at the time in stem cell research. The media picked up on it (or maybe they sent a lawyer in a white coat on Tucker, I don’t remember) and it was big news for a while and then went quietly away.
This seems to be on the same order as “stem cells for angina”. They are trying to sell it like it is a “new technology biological” treatment but it’s just an injection of “stem cells.”
I hear there is a new publication: The Journal of Homeopathic Molecular Biology. The editorial this month is all about Zinc Pores.
This therapy has got to be very expensive.
As I read it, it looks like a kind of Stem Cell Therapy.
No ordinary doctor can administer this.
...and I would expect it to work every bit as well as “Stem cells for angina”.
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