Stemedica Cell Technologies, Inc. ("Stemedica"), a San Diego-based biotech company specializing in the manufacture of clinical grade stem cells, announced today that it has signed a Licensing Agreement with Pulthera, LLC for the rights to use, distribute and sell its mesenchymal stem cell technologies in the treatment of COVID-19 and additional pulmonary conditions.
The agreement was confirmed today by Roger Howe PhD, Chairman and CEO of Stemedica. "We are pleased to announce this licensing agreement with Pulthera. Their team's clinical, fundraising and business development experience will help Stemedica advance our best-in-class stem cell technology to treat those with medical conditions resulting from COVID-19 or other pulmonary indications targeted by Pulthera."
Pulthera, a Delaware Incorporated Limited Liability Corporation, was formed for the express purpose of advancing medical solutions for those suffering from respiratory conditions including both acute and chronic forms of COVID-19. The company is led by Founder and Chairman David R. Grieve, a successful business development entrepreneur.
"When I heard of the significant results Stemedica's mesenchymal stem cells had in their 2020 COVID-19 Proof of Concept Clinical Trial, I wanted to team up with them and help bring the potential of their products to others suffering from respiratory medical indications for which there are limited or no treatment options," said David Grieve. "Since my first discussions with Stemedica, I have become more and more convinced that there is a serious, growing need for a therapeutic solution for those already impacted by having had COVID-19."
Stemedica's Proof of Concept Clinical Trial involved fourteen critically ill COVID-19 patients who were treated on Emergency Use and Expanded Use INDs at the Providence Saint John's Health Center (Santa Monica, CA) and ProMedica (Toledo, OH). The stem cell treatment resulted in an improved clinical course for the patients. The study found improved inflammatory modulation, and 88 percent of patients had a significant reduction in acute phase reactants (markers for reductions in inflammation) which resulted in a reduced "cytokine storm." Researchers noted that these patients experienced quicker extubation, less lung trauma and less oxygen toxicity. Stemedica went on to receive U.S. FDA approval for a Phase Ila clinical trial for patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.
Supporting David Grieve in developing clinically successful and commercially viable pathways for Pulthera is James Snider, who will serve as the Company's CEO. Mr. Snider is Pharma industry executive with over thirty-five years of experience, including professional positions at Novo Nordisk, Bioverativ and Sanofi Genzyme. "I've watched several pharmaceutical companies embrace stem cell partners only to fall short in clinical advancements. Their strategic thinking was correct, they simply chose the wrong stem cell technology. We sincerely believe Stemedica's ischemic tolerant cells manufactured at their government licensed, cGMP facility can create statistical points of difference clinically. In working with Stemedica, we seek to validate the important role stem cells can play in treating COVID-19 and other lung-related conditions which will require global solutions in the not-too-distant future," said Snider.
Pulthera anticipates advancing a multi-center trial in the treatment of those already afflicted with COVID-19, better known as "Long Haulers Syndrome," beginning late in 2021. These efforts will be coordinated in collaboration with the current FDA authorized Phase Ila clinical trial...
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