ELK CITY, Idaho–(BUSINESS WIRE)–Therapeutic Solutions International announced today filing with the Food and Drug Administration (FDA) an amendment to its currently open Phase III clinical trial requesting expansion of eligible patients with all patients suffering from Acute Respiratory Distress Syndrome (ARDS) regardless of cause.
The Company is currently only recruiting patients with advanced ARDS caused by COVID-19. The newly proposed criteria will allow all patients suffering from this condition to be eligible for entry into the clinical trial.
“In my opinion as a physician, as well as our Scientific Advisory Board, and our various collaborators, we strongly feel that the existing safety and efficacy profile of the JadiCell warrants expansion to other patients suffering from ARDS besides the COVID-19 associated population,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “We are confident that this decision will not only accelerate completion of the clinical trial but will also allow for treatment of a significantly larger patient population.”
Before the COVID-19 outbreak ARDS was believed to be approximately 200,000 cases per year in the United States and represents a multi-billion-dollar market. Currently there are no curative interventions available for advanced ARDS.
“We are honored to be guided by Key Opinion Leaders such as our SAB member Dr. Donald Banerji, former Head of Novartis Respiratory Medicine, during this process of taking JadiCell from an experimental research project into what appears to be a lifesaving medicine,” said Timothy Dixon, President, and CEO of the Company. “Based on the positive progress being made in understanding the JadiCell at both a clinical and molecular level, I am optimistic that we will be given the opportunity to address the larger problem of ARDS.”
About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company’s corporate website is www.therapeuticsolutionsint.com.