Pluristem Treated COVID-19 Patient in USA with 100% Success Rate
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that it has treated its first patient suffering from COVID-19 complications in the United States under the U.S. Food and Drug Administration’s (FDA) Single Patient Expanded Access Program, also called a compassionate use program, which is part of the U.S. Coronavirus Treatment Acceleration Program (CTAP), an emergency program for possible therapies that uses every available method to move new treatments to patients as quickly as possible.
The patient was treated with PLX cell therapy at Holy Name Medical Center in New Jersey, an acute care facility that is currently an active site for Pluristem’s Phase III critical limb ischemia (CLI) study. Prior to treatment with PLX, the patient was critically ill with respiratory failure due to acute respiratory distress syndrome (ARDS) and was under mechanical ventilation in an intensive care unit (ICU) for three weeks.
Holy Name Pluristem
Holy Name Medical Center is trying to create more scenes of coronavirus-recovered patients heading home. Some are the result of receiving investigational drugs – pharmaceuticals not made for COVID-19 but known to attack the effects of the virus. The FDA greenlights such drugs for clinical trials or individual compassionate use.
Holy Name is the first in the United States to use the latest one: Pluristem. Cells from a placenta are injected into the arms and legs of a 49-year-old COVID-19 man on a ventilator. The working theory for the cells starts with the mother’s body not rejecting the fetus when giving birth.
“Probably, there’s something in the Pluristem placenta, which might indeed be in the stromal cells, that calms down that immune reaction and tells the mother to not attack this embryo or fetus. So we’re actually using those properties of calm down the immune system, we’re using that now with COVID-19 trying to calm down that hyper-immune reaction that we’re seeing that a lot of patients have and that’s actually creating a lot of harm,” said Dr. Ravit Barkama, assistant vice president for clinical development at Holy Name Medical Center.
Barkama says the man is one of three critically ill patients without organ failure in the U.S. to receive the Pluristem placenta cells for compassionate use.
“We are encouraged because the patients are doing better, but it’s still hard to say that it’s because of the cells. We need a significantly larger group of patients to be able to say that it’s effective,” Barkama said.
Holy Name used Pluristem two years ago in a clinical trial — it one of only a couple of hospitals in the country.
Robert Masterson is a diabetic that had wounds that wouldn’t heal and had to have limbs amputated. He received 30 stem cell injections.
“In essence what we’re injecting is going to recruit blood vessels, cells that are involved in the healing of wounds,” said Dr. John Rundback, director of the Interventional Institute at Holy Name.
At a checkup 16 months later, Masterson reports improvement.
“Well, I’ve been able to do the stationary bike every day, at least 10 to 15 minutes every day. I have less trouble walking. They’ve saved my feet, really,” he said.
“I wouldn’t say it’s a miracle, but it’s definitely the future of medicine,” said Barkama.
For Barkama, that future could be now as Holy Name uses several therapies to improve the conditions of hundreds of coronavirus patients.
“The tool kit that the physicians had here at Holy Name and at other hospitals, that took kit was basically empty. We didn’t have treatments. At this point, we don’t have clearly proven treatments, but we have quite a bit of treatments that we at least perceive most of them as safe. So we would not try something investigational if it didn’t have a good safety profile,” she said.
In other words, if it didn’t have the potential of leading to more success stories.
“We’re injecting hope, not just cells,” Barkama added.
“We are receiving many inquiries and requests for treatment from healthcare providers and families worldwide. In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries. Our main focus remains however, the initiation of a multinational clinical study,” stated Pluristem CEO and President Yaky Yanay.
Pluristem main target is to initiate a multinational clinical trial as soon as possible for Pluristem PLX cells in the treatment of patients suffering from complications associated with COVID-19. As the Company focus is the initiation of such clinical trial, it does not intend to provide further updates on the status of patients treated under compassionate use. Pluristem will update on the status and progress of its planned COVID-19 clinical trial program.
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.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. Pluristem 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 offthe-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.
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