Israeli drug for severe COVID reduces death by 70% – phase 2 trial

An Israeli treatment for severe COVID-19 has been found to reduce mortality by 70% in a phase II clinical trial conducted at three major hospitals across the country.

Bonus BioGroup released new data this week showing that the 30-day survival rate of 50 seriously ill hospitalized patients with oxygen saturation of 93% or less and diffuse pneumonia who received up to three doses of the company’s MesenCure treatment was 94%. , that is, 47 out of 50 patients survived.

When comparing the first 30 patients in the trial with 60 similar patients who were used as a control group, the result is even more surprising: only 6.7% of the patients treated with MesenCure died of COVID-19 or its complications, compared to 23.3%. of the control group.

“The results are better than we expected,” said Dr. Shai Meretzki, CEO of the company. “We expected good results, but not so good results compared to the control group.”

The vaccine can be used to prevent coronavirus. New drugs from Merck and Pfizer are showing a chance of success in treating mild patients in the early stages of the virus. But there is still no drug available to help save the lives of the most severe COVID patients.

Empty syringes are displayed after a coronavirus vaccination in a doctor’s office in Berlin, Germany, on November 2, 2021. (Credit: REUTERS / HANNIBAL HANSCHKE / FILE PHOTO)

Pneumonia and cytokine storms that cause shortness of breath are a common complication of COVID-19, caused by excess accumulation of white blood cells and fluid in the lungs.

MesenCure is a cell therapy consisting of millions of live cells packaged and delivered with each dose. MesenCure consists of activated mesenchymal stromal cells (MSCs) that are isolated from the adipose tissue of healthy donors; A minimum of 45,000 doses can be produced from a single lipoaspirate donor after cell expansion and enhancement.

The cells are infused into a sick person, and in the infusion, the living cells travel through the bloodstream to the lungs. When they detect inflammation, MesenCure cells begin to secrete anti-inflammatory and regenerative factors. These factors reduce inflammatory cell activation and cytokine storm and prevent inflammatory cells from accumulating more in the lungs. They also promote the clearance of white blood cells and support tissue regeneration.

Once the inflammation has been relieved and excess fluid has been removed from the lungs, shortness of breath improves.

The phase II trial, as noted, included 50 patients, all defined as severe. Most of them also had some underlying medical condition that would make them more likely to die from COVID, such as diabetes, obesity, excess blood lipids or hypertension, explained Dr. Tomer Bronshtein, Head of Research at Bonus BioGroup. The patients were between 41 and 77 years old. Each one was matched with two critically ill patients with similar characteristics of sex, age and comorbidities who met the inclusion criteria of the clinical trial although they only received the best standard of care according to their condition and not MesenCure.

The trial took place at Rambam Health Care Campus, Kaplan Medical Center, and Baruch Padeh Medical Center.

Beyond the mortality results, MesenCure was also found to shorten the hospitalization period of treated patients by 45% from an average of 17.2 days to just 9.4 days, a difference of eight days.

About half of the critically ill patients treated with MesenCure were discharged from the hospital until just one day after the end of treatment, more than a third of the patients were discharged from the hospital the day their treatment ended, and more than 60 % of them were discharged up to two days after treatment.

Bronshtein said that about a third of the patients who were fired the day treatment ended could have been fired even before receiving the third and final dose, but simply stayed in the hospital to complete the trial. This means, he explained, that under real-world conditions, the reduction in hospitalization days is likely to be even greater.

“By freeing up intensive care unit beds, physicians will be able to provide better care for other patients,” Bronshtein said.

He added that the first patient to be given MesenCure, a 73-year-old woman, recovered so quickly after receiving just one dose of the treatment that doctors called the company to report that she was out of bed and exercising while next day.

“This was a very encouraging start for us,” he said, adding that accelerated healing will likely mean a lower risk of developing prolonged COVID and other COVID-related disabilities.

Based on these results, Meretzki said he is hopeful that soon Bonus BioGroup will be able to treat many more patients not only in Israel but in other parts of the world. He said the company is preparing the data to send to regulators in the United States and Europe.

“We hope to have results now that are good enough for emergency approval,” Meretzki said.

The data is also now being prepared for peer review by a major scientific journal. The Ministry of Health has already received the data and it has been reviewed by a board of external experts as required.

“People are dying,” Meretzki said. “We believe that we can save the lives of most of them.”



Reference-www.jpost.com

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