An Israeli coronavirus drug that claims to have a 100% success rate among severely ill patients is being tested in the United States for the first time.
The trial comes after Pluristem Therapeutics Inc., a biotech company based in Haifa, reported last week that seven patients who were at a high risk of death due to respiratory failure survived after receiving the medication.
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.
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 aims to conduct a multinational clinical study on the drug to better test for its effectiveness.
“We believe that research and governmental funding may be available to Pluristem to support the use of PLX cells for patients suffering from COVID19 and are targeting such funding,” he continued.
Swayampakula Ramakanth, a Wall Street analyst at H.C. Wainwright told Yahoo Finance he is “very encouraged” by the results.
“In our view, with the ongoing pandemic affecting nearly every country and stressing healthcare systems around the world, new, effective treatments are urgently needed,” he added. 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.
Pluristem says it has received many inquiries and requests for treatment since releasing last week’s report.
The NASDAQ reported that the biotech company’s shares gained more than 20 percent on Monday.
“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,” said Yanay.
“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,” stated Pluristem CEO and President, Yaky Yanay.