COVID-19: 100% Survival Rate Therapy of Israeli-based Pluristem Tested on US patient

The Israeli-based Pluristem Therapeutics Inc. announced on April 13 that it has treated its first American patient suffering from COVID-19 complications in the United States under the U.S. Food and Drug Administration (FDA) Single Patient Expanded Access Program or compassionate program.

This is a welcome development after six critically ill coronavirus patients in Israel were treated the company's placenta-based cell-therapy product and had 100 percent survival rate, according to the preliminary report provided by the company.

The recently treated patient was treated at Holy Name Medical Center in New Jersey with the company's PLX cell therapy. The said hospital is also where the company is already running a Phase III critical limb ischemia study.

The said patient was having a respiratory failure due to acute respiratory distress syndrome (ARDS) and was intubated in an intensive care unit for three weeks.

The recent treatment in the US was under the US Food and Drug Administration's Single Patient Expanded Access Program, a part of the US Coronavirus Treatment Acceleration Program (CTAP). CTAP is an emergency program that avails of every possible therapy to provide new treatments to patients the soonest time possible.

According to Pluristem CEO and President Yaki Yanay, they have been receiving a lot of inquiries and requests for treatment from healthcare providers and families around the globe. He said that the company will continue treating patients under the compassionate program through regulatory clearances in the United States and Israel parallel to their planned clinical trials. The main focus of the company, however, is the initiation of the multinational clinical study.

Since the focus is on the initiation of the said clinical trial, the company does not intend to provide further updates on the status of the patients treated under compassionate use. An update on the status and progress of its planned clinical trial program, however, will be done.

Pluristem also used the same compassionate program in Israel when they treated the first six patients. The treatment lasted one week in three different hospitals. The six patients had acute respiratory failure linked to complications with COVID-19. Four of the six patients had organ failure. According to Pluristem reports, all the patients survived a week later. Four of the patients showed improvement in respiratory parameters, and three are about to be weaned from ventilators. Patients with pre-existing medical conditions have shown respiratory improvement and clinical recovery.

The PLX cells are available off-the-shelf. Once commercialized, it can be manufactured in large scale quantities in the hopes of addressing the novel coronavirus pandemic.

Pluristem describes the recent PLX cells "allogeneic mesenchymal-like cells possessing immunomodulatory properties. These induce the immune system's natural regulatory T cells and M2 macrophages and thus, may prevent or reverse the dangerous overactivation of the immune system." The company also asserts that PLX cells have the potential to "reduce the incidence and severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients."

Other findings of PLX cells revealed therapeutic benefits in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury, most of which are complications of the severe COVID-19 infection.