Israeli Ministry of Health yesterday announced that it has authorized Enlivex Therapeutics Ltd [NASDAQ: ELNV] to proceed with phase II clinical trials for Allocetra, a medication that is being developed for severe and critical cases for COVID-19 patients.
The trial and study is a multi-group effort to develop a treatment for this group of patients (severe and critical). Those involved in the clinical trials are set to identify about 24 COVID-19 patients at severe and critical stages to administer this medication accompanied by the normal standard of care treatment. This trial is meant to check the safety, cytokine profile, tolerability, and efficacy measures in using this medication.
In just-concluded investigator-initiated trials of Phase Ib of Allocetra, Enlivex recorded positive results. The tests which they carried out on severe and critical cases of COVID-19 at Hadassah hospital in Israel, came out with top-line results indicating that they were on the right trajectory. Israeli Ministry of Health expects Enlivex to provide them with a full summary of the trials of Phase Ib after a 28-day observational period of five patients that were treated in this study that is expected to lapse at the end of October. The Ministry however has allowed Enlivex to provide a summary of these results before the 28-day period is over so that they can expedite the regulatory and review exercise. This was after the trials showed positive results, and had all the five patients that were part of the study released from hospital days before the trial period came to an end. All of them have tested negative for COVID-19.
In the Phase Ib clinical trials, there were three patients with a severe condition and two in critical condition. They all received specified doses of Allocetra. After an average of five days, those with a severe condition tested negative and were released, followed after about 4 more days by those with a critical condition. None of the patients, both severe and critical developed in medical or non-medical side effects following the administration of Allocetra.
In a joint statement, Enlivex Chief Executive Officer Oren Hershkovitz and Chief Medical Officer Pro. Dror Mevorach have thanked the Israeli Ministry of Health for expediting the review process and giving authorization for the Phase II trial of Allocetra. There is hope if these trials go on successfully for the world to begin emerging from this pandemic.