Therapeutic Solutions International (TSOI) announced it has filed a Phase III trial application with the US Food and Drug Administration (FDA) to investigate its stem cell therapy in acute respiratory distress syndrome (ARDS). The Elk City, Idaho-based biotech is using data from a previous Phase III trial targeting Covid-19 associated ARDS to support the investigational new drug (IND).
A key factor in TSOI’s submission was the US Patent Trial and Appeal’s Board to uphold validity of a patent granting the company exclusive rights to the composition of matter of its JadiCell stem cells. This patent is exclusively licenced to the company for lung and brain indications. TSOI already has positive findings for the stem cells in Covid-19 induced ARDS.
ARDS affects nearly 200,000 Americans a year. The condition gained widespread coverage during the Covid-19 pandemic, and drug development accelerated during this time. Now, TSOI plans to test its stem cell therapy for respiratory syndromes without the Covid-19 tag.
Dr James Veltmeyer, principle investigator of the study said that the ARDS market is greater than the Covid-19 market.
“The company has stayed a steady course in accomplishing its milestones of in-licensing an advanced cell therapeutic product, filing additional patents surrounding it, demonstrating in animal models and various clinical situations benefits of the product, and now taking the next step in product development by filing for entry into the ARDS patient population, which presents a significantly greater market than COVID-19 induced ARDS,” Veltmeyer said in a statement.
“We have numerous physicians eager to join the new trial, including ones who have previously witnessed significant patient improvement in previous clinical uses of our cells,” added Timothy Dixon, president and CEO of Therapeutic Solutions International.
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