Here is the article. They are still in the middle of a compassionate use only period. Next step in phase 2 for which they have only just recruited their first patient. No mention of phase 3. A fair bit behind Rem-L trials.
- 87.5% survival rate of patients on invasive mechanical ventilation injected with PLX cells
- 75% of patients no longer in need of any mechanical ventilation
- 62.5% of the patients discharged alive from the hospital
- A 28-day study period is also the primary endpoint timeline for Pluristem’s recently announced FDA Phase II study
HAIFA, Israel, May 14, 2020 (GLOBE NEWSWIRE) --Pluristem Therapeutics Inc.(Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, 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. All treated patients were in Intensive Care Units (ICU), on invasive mechanical ventilation and suffered from Acute Respiratory Distress Syndrome (ARDS) at the time of treatment. 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.
28-day follow up highlights for 8 patients treated with PLX cells:
- The survival rate of the 8 patients treated with PLX cells was 87.5%
- 75% were off any mechanical ventilation
- 62.5% were discharged alive from the hospital compared to 3.3% (38 out of 1151 patients) in data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive1
Notwithstanding the Company’s prior intention not to provide further updates on the status of patients treated under compassionate use, the 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. The Company intends to provide a final update regarding the compassionate use program in Israel and the FDA Single Patient Expanded Access Program in the U.S. once it has completed such programs and after it has completed its previously announced Phase II study with respect to the use of its PLX cells for the treatment of severe COVID-19 cases complicated by ARDS.
“We are highly encouraged by this data. The 28-day follow up time marker is important, as our Phase II study’s primary efficacy endpoint is the number of ventilator free days during the 28-day study period from day 1 though day 28,” stated Pluristem CEO and President, Yaky Yanay. “We are currently focused on initiating the Phase II clinical study in the U.S., where we expect to treat the first patient in the coming days. Simultaneously, we continue to help treat patients through our compassionate use and FDA Single Patient Expanded Access Programs in Israel and the U.S.”
PLX Cells for COVID-19
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities. Pluristem believes its PLX cells will offer a key advantage in addressing the COVID-19 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.
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.
https://www.globenewswire.com/news-release/2020/05/14/2033476/0/en/Pluristem-Provides-28-Day-Follow-Up-for-Ventilator-Dependent-COVID-19-Patients-under-Compassionate-Use-Program-in-Israel-and-U-S.html
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