Healthcare Industry News: ARDS
News Release - May 24, 2021
Stemedica Signs License Agreement with Pulthera, LLC for all Respiratory Indications including those related to COVID-19SAN DIEGO, May 24, 2021 -- (Healthcare Sales & Marketing Network) -- 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 Stemedica has already begun for COVID-19 patients hospitalized with Acute Respiratory Distress Syndrome.
Stemedica's Licensing Agreement with Pulthera is for the diagnosis, prevention and/or treatment of COVID-19 and complications thereof and for lung, pulmonary and respiratory conditions including, but not limited to, ARDS, Asthma, Bronchitis, COPD, Cystic Fibrosis, Emphysema, Pleural Effusion, Pneumonia, Pulmonary Fibrosis, and Reactive Airway Disease on a worldwide basis minus select markets where Stemedica already has contractual relationships in place.
About Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells used in US-based clinical trials for ischemic stroke, COVID-19 and Alzheimer's disease. Stemedica's products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stem cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California. www.stemedica.com
About Pulthera, LLC is a biopharmaceutical company focusing on the commercialization of "off the shelf" stem cell therapeutics designed to more effectively treat life-threatening inflammatory conditions in the lungs and COVID-19 related conditions. The Company has licensed the exclusive right to use, sell and distribute proprietary adult mesenchymal stem cells for all respiratory indications worldwide (some exclusions apply). Pulthera will participate in on-going clinical trials that are being led by its partners and will look to start its own clinical trials with the highest moral, ethical and safety standards. Visit www.pulthera.com for more information about the Company.
Source: Stemedica Cell Technologies
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