Floristem has received approval to start a Phase 2 clinical trial in Germany in Covid-19 patients

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The study will include 40 corona patients in critical condition and with acute respiratory distress syndrome. This coincides with the Phase 2 clinical trial in Corona patients that has already begun in the US and is expected to include 140 patients

The Israeli biotechnology company Floristem announced today that the German Ministry of Health has approved the experimental protocol presented by the company to conduct a Phase 2 study to examine the efficacy and safety of PLX cells for the treatment of coronary heart disease patients with a complication of acute respiratory distress syndrome. This coincides with the Phase 2 clinical trial in Corona patients that has already begun in the US and is expected to include 140 patients.

40 patients are expected to participate in the study, which is a randomized, controlled, multicenter assignment and in parallel groups.
The main parameter for evaluating the effectiveness of treatment is the number of days without a soul during the 28 days between the first day and the 28th day of the study. Polo-reviews to examine the safety and survival of patients will be held on the 60th day of the study as well as on the 26th and 52nd weeks. Floristem treatment is a drug produced from a suitable source of placenta in women after a cesarean delivery. Cellular therapy is given to patients by injection into the muscles, without any need for genetic matching between the donor and patient.

Findings from previous preclinical studies in PLX cells have demonstrated therapeutic efficacy in models of pulmonary hypertension and fibrosis as well as in models of acute renal and gastrointestinal injury that are possible complications of COVID-19 infection.

Floristem CEO and President Yaki Yanai said: “We are very pleased to be expanding our clinical treatment plan for Corona to Europe as well. As part of our discussions with the Paul Ehrlich Institute, the trial in Germany will stand on its own, and the active treatment arm will be tested against the current treatment. Floristem maintains a number of advanced clinical programs in Europe supported by Horizon 2020 and the European Bank (subject to funding). We appreciate their important support in our medical developments. Rehabilitating patients in Europe and around the world. “

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