An Israeli regenerative venture called Pluristem Therapeutics (PSTI) announced preliminary data from its compassionate use program, treating seven patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with Pluristem’s PLX cells in three medical centers based in Israel. These dangerous conditions place COVID-19 patients in considerable danger.
Preliminary Data Following Treatment with PLX Cells
Six of the seven patients have completed the seven day follow up period (Group A)., The seventh patient has not yet completed the seven day follow up.
- While the treated patients are considered high risk for mortality (Pavan K Bhatraju et al.), the preliminary data reveals 100% survival rate as of today
- Four patients (66%) out of Group A demonstrated improvement in respiratory parameters
- Three patients (50%) out of Group A are in advanced stages of weaning from ventilators
- One patient has shown no change in respiratory parameters, is still breathing with the assistance of a ventilator and remains relatively stable
- One patient has shown deterioration in respiratory parameters
- Two patients (50%) out of four in Group A with multi-organ failure prior to treatment, showed clinical recovery in addition to the respiratory improvement
Pluristem COVID-19: Headed to Multinational Clinical Trials
As a next step, the Company will apply for initiation of a multinational regulated clinical trial program for the potential use of PLX cells in the treatment of patients suffering from complications associated with COVID-19. In this regard, while Pluristem expects to continue treating patients for complications associated with COVID-19 under the compassionate use program in Israel, Pluristem does not intend to provide further updates on the status of this program and rather update on the status and progress of its contemplated clinical trial program.
PLX cells act by secreting therapeutic proteins in response to signals produced by the inflamed systemic areas in the body. By communicating with the body, PLX cells work with nature to provide blood to the body’s systemic areas. PLX cells grow with their proprietary 3D technology, including bar code feature, during their manufacturing process which allows the company to protect their intellectual property. They offer PLX products for a number of health issues, Peripheral and cardiovascular orthopedic pulmonary and hematological diseases.
PLX Cells for COVID-19
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.
Who is Pluristem?
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.
The company was founded way back in 2001 by Shai Meretzki of the Technion, who made use of a stem cell patent that was developed during his PhD studies at the Rappaport Faculty of Medicine, Technion. He was under the supervision of Dr. Shosh Merchav, working together with Professors Dov Zipori and Avinoam Kadouri from the Weizmann Institute of Science. By 2003, the NASDAQ-listed shell company A1 software acquired all shares and patents belonging to Pluristem and changed its name to Pluristem Life System. By 2007, the name was changed again to Pluristem Therapeutics, Inc. Pluristem’s shares are traded on the NASDAQ exchange and the Tel Aviv Stock Exchange.
Business & Finance
As of this writing, traded at $6.97 per share (market cap of $124.5m), the company is essentially pre-revenue and operates on a loss of free cash flow of $14.4 million, with $16 million in the bank. Founded back in 2003, it has raised over $70 million and is an operating company of Yeda Research and Development Co. Ltd of the Weizmann Institute.
As reported in its annual report, to be successful the company must be able to reduce costs in addition to raising profitable capital. The company’s core risks include its ability to raise sufficient additional capital, while also successfully finding and executing license agreements to use or commercialize the Company’s products. The company also seeks out non-diluting sources of money such as those from the Israeli Innovation Authority (IIA) as well as the European Union’s Horizon 2020 program.