Pluristem Therapeutics expects to treat more patients in Israel in the near future
It is in discussions with regulatory agencies in the U.S. and Europe to define its clinical strategy for COVID-19
HAIFA, Israel, March 30, 2020 — Pluristem Therapeutics (PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced that since its last update on COVID-19, it has dosed three patients in two different hospitals in Israel under a compassionate use program for the treatment of COVID-19, as approved by the Israeli Ministry of Health. Pluristem expects to enroll additional patients in Israel in the coming days and anticipates providing updates on clinical outcomes once significant data has been gathered.
All three treated patients are in a high-risk group based on age and preexisting conditions, have been experiencing severe respiratory failure, and intubation with a ventilator. Pluristem is closely following the medical condition of these patients in conjunction with the hospitals’ medical professionals delivering the care.
Pluristem is prepared for immediate ramp-up of PLX cell production with consistent batch-to-batch cell production quality through its GMP certified manufacturing facilities in order to meet potential demand.
“In this time of emergency, we are honored to be taking part in the global effort to support patients and healthcare systems. We watch with great admiration the endless efforts of the outstanding medical teams at the hospitals, and we would like to thank them for their collaboration and support. It is our hope that our mutual desire to help patients will result in improved outcomes for those hard hit by the life threating complications of COVID-19,” stated Pluristem CEO and President, Yaky Yanay.
“In addition to our current activity in Israel, we are in discussions with regulators in the U.S. and Europe to define our clinical strategy for COVID-19. Pluristem’s advanced manufacturing capabilities enable us to serve potential need of treating large numbers of patients under compassionate use and clinical studies across numerous countries and hospitals in accordance with our expansion program and regulatory approvals. We are facing a very different global condition right now, and the entire Pluristem team is committed to being an important part of the solution.”
PLX Cells for COVID-19
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the incidence and/or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients.
Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery. Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.
The potential therapeutic effects of PLX cells for the treatment of respiratory and inflammatory complications associated with the COVID-19 are currently being studied through a collaborative agreement between Pluristem and the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charite’ University of Medicine Berlin.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.