All treated patients were in Intensive Care Units (ICU) on ventilators and sufferedfrom Acute Respiratory Distress Syndrome(ARDS). 100% survival rate for all seven patients. 6 patients completed 1 week follow up; the seventh patientwas treated on April 52020•4 of the 6 (66%) patients thatcompleted 1 week follow up demonstrated improvement in respiratory parameters. 3 of the 6 (50%) patients thatcompleted 1 week follow up are in advanced stages ofweaning from ventilators. Pluristem plans to apply for initiation of multinational clinical trial for treatment of complications associated with COVID-19HAIFA, Israel, April 7,2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leadingregenerative medicine company developing a platform ofnovelbiological therapeuticproducts,announcedtoday preliminary data from its compassionate use program, treating seven patients suffering from acute respiratory failure and inflammatory complicationsassociated withCOVID-19with Pluristem’s PLX cells, in three medical centers in Israel. Patients’ condition prior to the treatment with PLX cells All seven patients approved for treatment under compassionate use program with PLX cellsexhibited, prior to treatment, respiratory failure due to ARDS, which is a major cause of mortalityand required mechanical ventilation inanICU. Four of the patients also demonstrated failure ofother organ systems, including cardiovascular and kidney failure, indicating critical disease andpoor prognosis. Former Technion student Dr Shai Meretzki has founded Pluristem in 2001.
Yaky Yanay PDG et président de Pluristem
Preliminary data following treatment with PLX cells. Six of the seven patients have completed the seven day follow up period (“Group A”). Theseventh patient has not yet completed seven day follow up.•While thetreatedpatients are consideredhighriskformortality (Pavan K. Bhatraju et al.https://www.nejm.org/doi/full/10.1056/NEJMoa2004500), thepreliminary datademonstrated 100% survival rateas of today.•Four patients (66%)out ofGroup A demonstrated improvement in respiratoryparameters.
Three patients(50%) out of Group A are in advanced stages of weaningfrom ventilators. One patienthas shown no change in respiratory parameters, is stillbreathing with theassistance of a ventilator and remains relatively stable. One patient has shown deteriorationin respiratory parameters. Two patients (50%) out of four in Group A with multi-organ failureprior to treatment,showed clinical recovery in addition to the respiratory improvement.Pluristem’s COVID-19clinical development strategyAs a next step, the Company plansto applyfor initiation ofa multinationalregulatedclinical trialprogramfor thepotentialuse of PLX cells in the treatment of patients suffering fromcomplications associated with COVID-19. In this regard, whilePluristemexpects to continuetreating patientsfor complications associated with COVID-19 under thecompassionate useprogram inIsrael, Pluristem does not intend to provide further updates on the status ofthisprogram and rather update on the status and progress of its contemplated clinical trial program.“We are pleased with this initial outcome of the compassionate use program, andcommitted toharnessing PLX cells for the benefit of patients and healthcare systems. In order to maximize PLXcells’ impact on patient recovery and to work towards makingour treatment widely available,we plan to quicklymove forward into a clinical development program. Pluristem is dedicated tousing its competitive advantages inlarge-scalemanufacturingtopotentiallydeliverPLX cells to alarge number of patients in significant need. Webelievethatresearch andgovernmental fundingmay be available to Pluristemto supportthe use of PLX cells for patients suffering from COVID-19and are targeting such funding,” stated Pluristem CEO and President, Yaky Yanay.PLX Cells for COVID-19PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scalequantities, offering a key advantage in addressing a global pandemic. PLX cells are allogeneicmesenchymal-like cells that have immunomodulatory properties that induce the immunesystem’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse thedangerous overactivation of the immune system. Accordingly, PLX cells may potentially reducethe incidence and/or severity of COVID-19 pneumonia and pneumonitis leading hopefully to abetter prognosis for the patients. Previous pre-clinical findings of PLX cells revealed therapeuticbenefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury andgastrointestinal 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 safetyprofile observed from clinical trials involving hundreds of patients worldwide potentially positionthem as a therapy for mitigating the tissue-damaging effects of COVID-19.About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novelplacenta-based cell therapy product candidates. The Company has reported robust clinical trialdata in multiple indications for its patented PLX cell product candidates and is currentlyconducting late stage clinicaltrials in several indications. PLX cell product candidates are believedtorelease a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma,hematological disorders and radiation damage. The cells are grown using the Company’sproprietary 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 operatedGMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.Safe Harbor Statement
Pluristem is using forward-looking statements when it discussesthe interim results fromthe useof PLX cells on certain patients suffering from COVID-19, its expectation to continue treatingpatients for complications associated with for COVID-19 under the compassionate use programin Israel and its intention not to provide further updates on the status of this program and ratherupdate on the status and progress of its contemplated clinical trial program, its plans toapply for initiation of a multinational clinical trialin order to maximize PLX cells’impact on patient recovery and to work towards making its treatment widely available, itsdedication to using its competitive advantages in large-scale manufacturing to potentially deliverPLX cells to a large number of patients in significant need, its belief that research andgovernmental funding may be available to it to support its PLX cells for COVID-19 patients and itsintent to target such funding, the potential of PLX cells in preventing or reversing the dangerousoveractivation of the immune system, that PLX cells maypotentially reduce the fatal symptomsof COVID-19induced pneumonia andpneumonitis, andPLX cells’ position as a therapy formitigating the tissue-damaging effects of COVID-19. These forward-looking statements and theirimplications are based on the current expectations of the management of Pluristem only, andare subject toa number of factors and uncertainties that could cause actual results to differmaterially from those described in the forward-looking statements. The following factors, amongothers, could cause actual results to differ materially from those described inthe forward-lookingstatements: changes in technology and market requirements; Pluristem may encounter delaysor obstacles in launching and/or successfully completing its clinical trials; Pluristem’s productsmay not be approved by regulatory agencies, Pluristem’s technology may not be validated as itprogresses further and its methods may not be accepted by the scientific community; Pluristemmay be unable to retain or attract key employees whose knowledge is essential to thedevelopment of its products; unforeseen scientific difficulties may develop with Pluristem’sprocess; Pluristem’s products may wind up being more expensive than it anticipates; results inthe laboratory may not translate to equally good results in real clinical settings; results ofpreclinical studies may not correlate with the results of human clinical trials; Pluristem’s patentsmay not be sufficient; Pluristem’s products may harm recipients; changes in legislation mayadversely impact Pluristem; inability to timely develop and introduce new technologies, productsand applications; loss of market share and pressure on pricing resulting from competition, whichcould cause the actual results or performance of Pluristem to differ materially from thosecontemplated in such forward-lookingstatements. Except as otherwise required by law,Pluristem undertakes no obligation to publicly release any revisions to these forward-lookingstatements to reflect events or circumstances after the date hereof or to reflect the occurrenceof unanticipatedevents. For a more detailed description of the risks and uncertainties affectingPluristem, reference is made to Pluristem’s reports filed from time to time with the Securitiesand Exchange Commission.