placenta-based cell therapy / Charite - University of Medicine Berlin, Pluri - LARVOL DELTA

Could cell therapy target the symptoms of severe Covid-19? (Labiotech.eu) - P1/2, N=NA; "Athersys’ cell therapy is being trialed....Results from a completed a phase I/II study testing Multistem....The study showed that treatment with the cell therapy reduced mortality from 40% to 25% in these very sick patients....Pluristem’s cells are delivered ‘off the shelf’....Pluristem found that 87.5% survived, 75% no longer needed ventilation and 62.5% had been discharged from hospital. The company now plans to start a phase II trial of its therapy in the US, which has been cleared by the FDA, and is waiting for clearance to start a trial in Germany and Italy....Alliance for Regenerative Medicine is currently tracking 24 ongoing clinical trials and an additional 25 preclinical studies for cell therapies against Covid-19."

Clinical data • New P2 trial • P1/2 data • Infectious Disease • Novel Coronavirus Disease

Could placenta cells save patients with severe Covid-19? (Open Access Government) - P=NA, N=NA; "Israeli therapeutics firm, Pluristem, have recently pioneered a breakthrough treatment....Initial results show that after receiving the placenta cell therapy for a duration of one week, all patients have survived. Four of the patients have shown significant improvements in respiratory parameters and three are in the advanced stages of moving off ventilators....In Europe, clinical trials using placental cells are expected to launch in Germany and Italy....Initial positive results from a recent study have shown that amniotic membrane patches and placental cell injections could treat cardiovascular defects and inflammatory cardiovascular conditions."

Clinical data • Cytokine storm • Acute Respiratory Distress Syndrome • Novel Coronavirus Disease

Pluristem Provides 28-Day Follow Up for Ventilator-Dependent COVID-19 Patients under Compassionate Use Program in Israel and U.S. (GlobeNewswire, Pluristem Therapeutics, Inc.) - "Pluristem Therapeutics Inc...today reported an update on the status of COVID-19 infected patients treated with PLX cells under a compassionate use program in Israel and the FDA Single Patient Expanded Access Program in the U.S....As of today, a total of 18 patients were treated in Israel and in the U.S., of which 8 (1 in the U.S. and 7 in Israel) so far have completed a 28-day follow up period....The survival rate of the 8 patients treated with PLX cells was 87.5%....Company is now providing this update in response to a substantial increase in shareholder inquiries, following the FDA clearance of Phase II study and prior to recruitment of the first patient."

Clinical data • Enrollment status • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study (GlobeNewswire, Pluristem Therapeutics, Inc.) - "Pluristem Therapeutics Inc....announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase II study of its PLX cells in the treatment of severe COVID-19 cases....The study, titled 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19' will treat 140 adult patients that are intubated and mechanically ventilated....The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study.....A Clinical Trial Authorization (CTA) has also been filed in Europe for a Phase II COVID-19 trial, with the first European clinical sites planned in Germany and Italy."

European regulatory • IND • New P2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Pluristem secures €50 million non-dilutive financing from the European Investment Bank to support its Covid-19 project and phase III studies (GlobeNewswire) - "Pluristem Therapeutics Inc....announced today that the European Investment Bank ('EIB') has approved a €50 million non-dilutive financing for the Company (the 'Approved Financing'). This Approved Financing, once received, will support Pluristem’s research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19....The expected signing date of the financing agreement relating to the Approved Financing is April 30, 2020."

Financing • Infectious Disease • Novel Coronavirus Disease

Pluristem Expands its Compassionate Use Program: Treated First COVID-19 Patient in U.S. Under FDA Single Patient Expanded Access Program (GlobeNewswire, Pluristem Therapeutics, Inc.) - "Pluristem Therapeutics Inc....announced today that it has treated its first patient suffering from COVID-19 complications in the United States under the U.S. Food and Drug Administration’s (FDA) Single Patient Expanded Access Program....'In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel'....Pluristem’s main target is to initiate a multinational clinical trial as soon as possible for PLX cells in the treatment of patients suffering from complications associated with COVID-19. As the Company focus is the initiation of such clinical trial, it does not intend to provide further updates on the status of patients treated under compassionate use."

New trial • Non-US regulatory • Regulatory