Pluristem Therapeutics (Nasdaq: PSTI)(TASE: PSTI), a Haifa Israel-based regenerative medicine company, reports significant results from ongoing treatment of COVID-19 patients with its biological therapeutic products. According to recent news, 75% of those COVID-19 patients treated by the company’s regenerative therapy were off any mechanical ventilation after 28 days of treatment.
Compassionate Use Programs in Israel and America
Under a compassionate use program in Israel, in addition to an FDA Single Patient Expanded Access Program in the United States, treated patients were in Intensive Care Units (ICU), on invasive mechanical ventilation and were suffering from Acute Respiratory Distress Syndrome (ARDS) at the time of treatment.
The Regenerative Therapy
The patients were treated with the company’s PLX cells. As of last week, 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% of the patients 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 alive
CEO and President Yaky Yanay commented, “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 through day 28.” According to the CEO, the company will now initiate a Phase II clinical study in the U.S where they are planning on treating the first patient in days.
Can PLX Cells Reverse the Dangerous Overreaction of Immune System in COVID-19?
PLX Cells for COVID-19 are available off-the-shelf and once commercialized, can be manufactured in large scale quantities. According to Pluristem, its PLX cells offer a key advantage in addressing COVID-19. They 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 overreaction of the immune system.
If this is true what are the benefits?
Well if PLX cells can prevent the overreaction of the immune system they can potentially reduce the incidence and/or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients.
Did PLX cells reveal benefit in preclinical animal studies?
Yes. During animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury, which are potential complications of the severe COVID-19 infection.
What about benefits in human patients?
Yes. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery. PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position PLX cells as a therapy for mitigating the tissue-damaging effects of COVID-19.
What is the company background?
They position themselves as a leading regenerative medicine company developing novel placenta-based cell therapy candidates. Founded in 2001 by Shai Meretzki of the Technion, he made use of a stem cell patent, which was developed during his PhD studies at the Rappaport Faculty of Medicine, Technion, under the supervision of Dr. Shosh Merchav, along with Dov Zipori and Avinoam Kadouri from the Weizmann Institute of Science.
By 2007, Pluristem inked a collaborative agreement with Charite medical school in Berlin for a five-year term. They renewed the agreement until 2017. By 2012, the company won a government award of $2.4 million from the Office of the Chief Scientist of Israel. They won another grant that same year totaling $3.2 million.
In August 2016, Pluristem benefited from an $8 million grant form Europe’s Horizon 2020 Program to help cover some of the costs of their European Phase III study of PLX-PAD cells in the treatment of critical limb ischemia.
Currently trading at $9.89 per share, equaling a market capitalization of $250.56 million, the company positions all of its intellectual property on “placenta-derived cells” as a superior regenerative technology approach—why? See below.
- Ethically accepted
- Rich & diverse
- Pro-angiogenic & immunoregulatory
- Young donors
- Unlimited source & easy to collect
- Ability to manufacture treatments for over 20,000 patients per placenta
Moreover, the company posits that its “marketing-ready industrialized technology platform” includes state-of-the-art, proprietary bioreactor system which offers them a 3D micro-environment for cells that mimics the human body condition, not to mention controlled, automated and efficient scalable manufacturing technology with unique controls and flexible attributes.
Their pipeline includes Critical Limb Ischemia (Phase III in US, Europe & Israel); Muscle Regeneration following Hip Fracture (Phase III in US, Europe & Israel) as well as others.
€50 million European Investment Bank Financing
Last month Pluristem Therapeutics received a €50 million “venture loan” also associated with the kENUP Foundation.