The experiment will take place in several medical centers, and it is expected to recruit up to 24 COVID-19 patients in severe and critical condition. The trial was designed to test Allocetra in combination with standard treatment in patients. Safety, tolerability, cytokine profile and efficacy parameters will be tested
Enlivex Therapeutics (Nasdaq: ENLV), an immunotherapy company in the clinical trial phase, reports that the Israeli Ministry of Health has approved the start of a Phase 2 clinical trial, which will test Allocetra for the treatment of severe and critical COVID-19 patients.
The planned experiment will be in several medical centers, and it is expected to recruit up to 24 COVID-19 patients in severe and critical condition. The trial was designed to test Allocetra in combination with standard treatment in patients. Safety, tolerability, cytokine profile and efficacy parameters will be tested.
Enalivex recently reported positive results in a phase Ib clinical trial of Allocetra To treat corona patients in serious and critical condition at Hadassah Hospital, one of the largest hospitals in Israel. The company was supposed to provide the Israeli Ministry of Health with a full summary of the trial results after a period of 28 days from the date of treatment of each of the five patients, and this 28-day period ends near the end of October.
Nevertheless, based on the positive results and the discharge from the hospital of all the patients treated in the trial when they were negative in the PCR test for 19-Covid, the Israeli Ministry of Health requested an accelerated submission by Enlivex of the summary of the phase Ib clinical trial even before the 28-day period of the last patient treated had ended As part of the latest experiment, with the aim of speeding up the regulatory procedure.
The phase Ib clinical trial included 5 corona patients, 3 of them in serious condition and 2 more in critical condition. All five patients recovered completely from the previous condition and were discharged from the hospital after an average of 5 days (patients in serious condition) and 9 days (patients in critical condition) after starting treatment with Allocetra. All patients received a negative result in the 19-COVID PCR test at the time of discharge. No serious side effects were reported as a result of Allocetra treatment, and the treatment was defined as tolerable.
CEO of Enlivex Dr. Oren Hershkovich and the company's medical director Prof. Dror is blessed We jointly stated that "we would like to thank the Israeli Ministry of Health for the quick and extraordinary examination on its part, and for approving a phase 2 clinical trial in Allocetra for the treatment of corona patients in a severe and critical condition."
More of the topic in Hayadan:
- Five seriously ill corona patients who received an experimental drug at Hadassah have recovered
- Researchers from the Hebrew University and Mount Sinai Hospital in New York cracked the replication mechanism of the corona virus and found an existing drug that attacks it
- A drug given to Gaucher patients blocks the replication of the corona virus in the cell
- Trump received experimental treatment with antibodies against Corona. What are the effective treatments so far?
