The Israeli coronavirus drug reportedly with a 100% success rate even among severely ill patients is being tested in the United States for the first time.
Pluristem Therapeutics Inc., a biotech company based in Haifa/Israel, reported that seven patients who were at a high risk of death due to respiratory failure, multi-system organ failure, including heart and kidney failure survived after receiving this medication.
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.
Now, a critical COVID-19 patient in the US has been treated with PLX cell therapy at Holy Name Medical Center in New Jersey. The results of the treatment have yet to be released.
Pluristem Therapeutics uses placentas to grow smart cells and programs them to secrete therapeutic proteins in the bodies of sick people.
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.
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.”