Enlivex Therapeutics (ENLV) Reports Positive Top-Line Results from Phase II Clinical Trial Evaluating Allocetra in Severe and Critical COVID-19 Patients and Provides a Program Update
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Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, today reported positive top-line results from a multi-center, investigator-initiated Phase II clinical trial evaluating AllocetraTM in severe and critical COVID-19 patients. Based on the positive results and in consultation with the trial’s principal investigator, the Company has completed the trial early and plans to submit a summary of the data for review by the relevant regulatory bodies. Submission of the data summary to regulators is expected later this month and will serve as the basis for a discussion with regulators on the next steps in Allocetra’s regulatory pathway in COVID-19 patients with severe or critical illness.
Sixteen COVID-19 patients were treated with AllocetraTM in the Phase II clinical trial, which originally was expected to enroll twenty-four patients. The clinical trial was completed early in support of anticipated accelerated regulatory filings of the trial’s positive safety and efficacy data. Of the sixteen patients enrolled in the Phase II trial, nine (9/16, 56%) were in severe condition and seven (7/16, 44%) were in critical condition.
Key results and conclusions from both the Phase II clinical trial, as well as a previously reported investigator-initiated Phase Ib study of AllocetraTM in severe and critical COVID-19 patients, include:
- Fourteen of sixteen (87.5%) Phase II trial patients had recovery from their respective severe/critical condition and were discharged from the hospital after an average of 5.3 days following AllocetraTM administration (average of 4.2 days for severe patients and 7.2 days for critical patients).
- Nineteen of twenty one (90.5%) Phase II and Phase Ib trial patients, in the aggregate, had recovery from their respective severe/critical condition and were discharged from the hospital after an average of 5.6 days following AllocetraTM administration (average of 4.1 days for severe patients and 7.7 days for critical patients).
- The mortality rate at 28 days (day-28 post-AllocetraTM treatment was the end of the trial’s follow-up period) for participants in the Phase II trial was 0% (0/16). The same 0% (0/21) mortality rate was observed in an aggregate analysis of all patients treated in the Phase Ib and Phase II studies.
- Majority of the patients treated in the Phase Ib and Phase II studies had pre-existing risk factors such as male gender, obesity and hypertension
Data from the investigator-initiated Phase II trial, as well as an audited analysis of the Phase Ib trial are shown below:
|Clinical Trial||# Patients enrolled||Disease Severity||Clinical Outcome||Hospitalization Discharged patients, post Administration of AllocetraTM|
|Recovered Day 28||Mortality Day 28||Discharged Day 28||Duration (days, avg.)|
|Phase Ib||5||2 Severe 3 Critical||5/5 (100%)||0/5 (0%)||5/5 (100%)||6.6|
|Phase II||16||9 Severe 7 Critical||14/16 (87.5%)||0/16 (0%)||14/16 (87.5%)||5.3|
|Total||21||11 Severe 10 Critical||19/21 (90.5%)||0/21 (0%)||19/21 (90.5%)||5.6|
Prof. Vernon van Heerden, Head of the General Intensive Care Unit at Hadassah Medical Center in Israel and the lead investigator of both the prior Phase Ib and the now-completed Phase II clinical trials of AllocetraTM in severe and critical COVID-19 patients stated, “The results we have seen from the twenty-one COVID-19 patients treated to date with AllocetraTM are exciting. The Phase II patients who have been discharged from the hospital are currently healthy. We believe that these compelling results have demonstrated the safety and efficacy of AllocetraTM in these complicated patients, highlighting the potential of Enlivex’s product candidate to benefit severe and critical COVID-19 patients as well as others suffering from cytokine storms and organ dysfunctions across various clinical indications.”
Prof. Dror Mevorach, M.D., Chief Scientific and Medical Officer of Enlivex, added, “We believe the results from the COVID-19 clinical trials of AllocetraTM represent a unique opportunity for severe and critical COVID-19 patients, on top of standard of care. The data suggest that AllocetraTM may have utility as a safe and efficacious treatment for reprogramming macrophages and resolving states of organ failures both in this COVID-19 patient population, regardless of the specific coronavirus mutation that inflicted the patients, and across different life-threatening, high mortality clinical indications with high unmet medical needs.”
Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex commented, “We are pleased with the top-line results of this Phase II clinical trial. We believe that AllocetraTM, if approved, could potentially cover the void that currently exists for the treatment of severe and critical COVID-19 patients. COVID-19 vaccines are game-changers in the fight against the pandemic, yet with various surveys demonstrating 25-32% of the population in the United States and major European countries unwilling to get vaccinated1, and concerns surrounding various mutant strains of the SARS-CoV-2 virus, our commercial model estimates continued demand for the treatment of severe and critical COVID-19 patients for years to come.”
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