MesenCure (adipose tissue derived activated mesenchymal stromal cells) / Wize Pharma, Bonus BioGroup - LARVOL DELTA

A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: BonusBio Group Ltd | Trial completion date: Jul 2026 ➔ Oct 2028 | Trial primary completion date: Jun 2026 ➔ Jun 2028

Trial completion date • Trial primary completion date • Respiratory Diseases

Bonus Biogroup Announces U.S. Food and Drug Administration (FDA) Clearance of an Investigational New Drug (IND) Application for MesenCure Phase III Clinical Study in Respiratory Distress (GlobeNewswire) - "Bonus Biogroup...today announced that it has received U.S. Food and Drug Administration (FDA) clearance to proceed with a Phase III clinical study in the United States to evaluate the efficacy and safety of MesenCure (allogeneic cell therapy consisting of enhanced adipose tissue-derived MSC) to treat respiratory distress in hospitalized, severely ill patients resulting from pneumonia related to COVID-19....The Company is working to expand the Phase III clinical study indication to include the treatment of respiratory distress that manifests from any cause, including acute respiratory distress syndrome (ARDS), based on clinical and preclinical findings indicating MesenCure's potential in treating this indication, regardless of its underlying etiology."

IND • New P3 trial • Acute Respiratory Distress Syndrome • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19 (clinicaltrials.gov) - P1/2 | N=50 | Completed | Sponsor: BonusBio Group Ltd | Recruiting ➔ Completed | N=35 ➔ 50

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease

A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With ARDS (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: BonusBio Group Ltd | Trial completion date: Jul 2024 ➔ Jul 2026 | Trial primary completion date: Dec 2023 ➔ Jun 2026

Trial completion date • Trial primary completion date

A Controlled Study to Evaluate the Efficacy of Allogeneic MesenCure for the Treatment of Patients With COVID-related Pneumonia (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: BonusBio Group Ltd

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia

Possible Divergent Local and Peripheral Immunological Effects of Low-Dose Mesencure, an Enhanced Mesenchymal Cell Therapy, May Contribute to Its Success in Treating Severe Covid-19 Patients (ASH 2021) - "Further research is inevitably required into the mechanism behind this phenomenon. However, our results indicate MesenCure’s potential in relieving local inflammation while giving the patient a fighting chance against viremia."

Clinical • Acute Lung Injury • Acute Respiratory Distress Syndrome • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CD4 • CD8 • EDIL3 • IL6

Israeli biotech company aces Phase I Covid cure trial (Israel21c) - P1/2, N=60; NCT04716998; Sponsor: BonusBio Group Ltd; "Israeli biotechnology company Bonus BioGroup recently announced positive preliminary results of its Phase I clinical trial for treating severely ill Covid-19 patients...The trial involved treating 10 Covid patients...'All of the patients being treated with MesenCure were severe Covid patients whose illness was manifested in acute respiratory distress'...'The patients exhibited significant improvements in the parameters tested,' he adds. After the treatment, they spent one day in outpatient care before being discharged. Following the trial’s success, the Israeli Health Ministry has approved transition to Phase II, which will include an additional 50 coronavirus patients."

P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19 (clinicaltrials.gov) - P1/2; N=35; Recruiting; Sponsor: BonusBio Group Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19 (clinicaltrials.gov) - P1/2; N=35; Not yet recruiting; Sponsor: BonusBio Group Ltd

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease