Therapeutic Solutions International Files with FDA to Expand ongoing Phase III Clinical Trial to Include All Causes of Acute Respiratory Distress Syndrome
Therapeutic Solutions International Files with FDA to Expand ongoing Phase III Clinical Trial to Include All Causes of Acute Respiratory Distress Syndrome
Therapeutic Solutions International has submitted an amendment to the FDA for its Phase III clinical trial, expanding eligibility for patients with Acute Respiratory Distress Syndrome (ARDS) to include all causes, not just those related to COVID-19. This expansion aims to address a significant market opportunity, as ARDS cases in the U.S. reach approximately 200,000 annually, with no current curative options. The company believes this move will accelerate the trial's completion and increase patient access to JadiCell, a promising treatment.
Positive
Amendment submitted to FDA to expand Phase III clinical trial for JadiCell, enhancing patient eligibility.
Potential to address a significant market estimated at $17 billion with around 200,000 ARDS cases annually.
Confident in the safety and efficacy of JadiCell, as stated by the CMO and supported by the Scientific Advisory Board.
Negative
None.
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Company Eyes Targeting 17 Billion Dollar Market Using Universal Donor Adult Stem Cell Therapy
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.
What is the latest development for TSOI's clinical trial?
Therapeutic Solutions International has amended its Phase III trial to include all patients suffering from ARDS, not just those caused by COVID-19.
How many ARDS cases are there in the U.S. annually related to TSOI's trial?
There are approximately 200,000 cases of ARDS in the U.S. annually.
What is the significance of the FDA amendment for TSOI's JadiCell?
The FDA amendment allows for a larger patient population in the trial, potentially accelerating its completion and addressing a market valued at $17 billion.
What is the expected market impact of JadiCell for TSOI?
JadiCell aims to capture a share of the multi-billion dollar ARDS market, especially as there are currently no curative treatments available.
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