Therapeutic Solutions International Completes Purchase of FDA Phase III JadiCell Stem Cell Investigational New Drug Application from University of Miami

Rhea-AI Summary

Therapeutic Solutions International (TSOI) has executed a purchase agreement for sponsorship of a pivotal Phase III clinical trial evaluating JadiCell adult stem cells for treating COVID-19 related lung failure.

Dr. Thomas Ichim emphasized the trial's impact on both COVID-19 and ARDS patients, with potential FDA registration for JadiCell as a leading cell-based therapy. The company has secured multiple patents for JadiCell, enhancing its market position. Dr. James Veltmeyer is designated as the Principal Investigator, taking control of trial conduct. TSOI acknowledges shareholder support during this significant initiative.

Positive

• Execution of a purchase agreement for a Phase III clinical trial, enhancing company control over the trial.
• Potential FDA registration for JadiCell, opening access to a multibillion-dollar market.
• Multiple patents secured for JadiCell, reinforcing intellectual property position.

Negative

• None.

Transfer of Trial Sponsorship Final Major Milestone before Initiation of Lung Failure Pivotal Clinical Trial

OCEANSIDE, Calif.--(BUSINESS WIRE)-- Therapeutic Solutions International announced today the execution of a purchase agreement covering sponsorship and leadership of the FDA cleared Phase III pivotal trial assessing JadiCell adult stem cells for treatment of COVID-19 associated lung failure.

“This pivotal trial has significant implications not only to COVID-19 patients with severe lung compromise but also the significant population of patients suffering from acute respiratory distress syndrome (ARDS),” said Dr. Thomas Ichim, Director of the Company. “If the trial is successful, we anticipate FDA registration of JadiCell as the first cell based therapeutic to address ARDS which represents a multibillion-dollar market.”

The Company previously licensed issued patent # 9,803,176 B2 covering the composition of matter of the JadiCells and has filed nine additional patents on novel uses and combinations as well as one manufacturing patent. The purchase of the Investigational New Drug application allows the Company to run the clinical trial as an “Industry Sponsored” investigation as compared to “Investigator Initiated,” thus allowing full control of trial conduct.

As part of the trial organization, the Principal Investigator has been changed to Dr. James Veltmeyer and Therapeutic Solutions International, Inc as the Sponsor.

“I am honored to be chosen to run this double blind, placebo controlled, multi-hospital clinical trial assessing a novel cell-based therapy to address this significant unmet medical need,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “I have seen first-hand the suffering and lack of medical options available for patients with lung failure and I am proud to work towards development of a solution.”

“We thank our shareholders and our supporters who have stood beside the Company since our initiation of the COVID-19 JadiCell program,” said Timothy Dixon, President, and CEO of the Company. “Today’s event marks a significant step in the initiation of our clinical trial.”

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220325005233/en/

Tim G. Dixon

ir@tsoimail.com

Source: Therapeutic Solutions International, Inc.

FAQ

What is the latest news about Therapeutic Solutions International (TSOI) regarding their clinical trial?

Therapeutic Solutions International (TSOI) has secured sponsorship for a Phase III clinical trial assessing JadiCell for COVID-19 related lung failure.

When will the Phase III trial for JadiCell by TSOI start?

The execution of the purchase agreement marks a significant milestone in initiating the Phase III clinical trial.

What are the implications of TSOI's new clinical trial for investors?

If successful, the trial could lead to FDA approval, significantly increasing TSOI's market potential and shareholder value.

Who is leading the new clinical trial for TSOI?

Dr. James Veltmeyer has been appointed as the Principal Investigator for the JadiCell clinical trial.

What is the market potential for JadiCell if the trial is successful?

The successful trial may allow JadiCell to enter a multibillion-dollar market for treating ARDS.