Therapeutic Solutions International Granted Emergency IND by FDA for Expanded Patient Access to JadiCell™ Universal Donor Stem Cell for COVID-19 ARDS Outside of Ongoing Phase III Clinical Trial

Rhea-AI Summary

Therapeutic Solutions International has received Emergency IND #28685 and a “May Proceed Notification” from the FDA for advanced COVID-19 ARDS treatment, facilitating the use of JadiCells for patients outside of a Phase III trial. The company previously treated 15 no-option patients under eIND and Right to Try laws. CMO Dr. James Veltmeyer emphasized the urgent need for these therapies, especially with rising COVID-19 cases. The JadiCell, currently in Phase III, has shown superior activity compared to other stem cell therapies and is also being developed for COPD and other conditions.

Positive

• Emergency IND #28685 granted by FDA allows for rapid patient access to JadiCells for COVID-19 treatment.
• Successful treatment of 15 patients under expanded access criteria demonstrates capability to meet urgent medical needs.
• Positive relationships with FDA facilitate rapid regulatory approval and movement for stem cell therapies.

Negative

• None.

Company Responds to Rapidly Growing COVID-19 Cases by Increasing Mechanisms to Make Lung Healing Cells Available

ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International announced today granting of Emergency IND # 28685 and a “May Proceed Notification” from the Food and Drug Administration (FDA) for the treatment of advanced COVID-19 ARDS outside of the currently ongoing Double Blind Placebo Controlled Phase III clinical trial for the same indication. The Company previously announced treatment of 15 "no option patients” under both “eIND” and “Right to Try” Law¹.

“Based on my clinical experience with the JadiCells, their therapeutic effects are unparalleled in comparison to any other stem cell therapy,” said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International. “With the increase in COVID-19 cases, as well as the anticipated deluge of COVID-19 ‘long hauler’ patients, it is imperative that we have mechanisms to provide these cells to patients who desperately need them, even if it is outside of the clinical trial. Our number one mission as a Company is to accelerate development of these cells as rapidly as possible and to save people’s lives.”

Previously the Company has demonstrated superior activity of JadiCells to other stem cells, as well as identifying mechanisms of action^2,3. The JadiCell is currently in Phase III for COVID-19 ARDS⁴, has been granted IND numbers for COPD⁵, and Chronic Traumatic Encephalopathy⁶, and is in late preclinical development for Idiopathic Pulmonary Fibrosis⁷.

“We are thankful for the brave doctors that approach us and work with us to provide accelerated access to potentially life-saving cell therapies such as JadiCells to their patients,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “We are blessed to have very positive relations with the FDA which has allowed for rapid movement through the various regulatory hurdles involved in development and commercialization of stem cell therapies.”

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.

¹ Therapeutic Solutions International Successfully Treats "No Option" Patients with its JadiCell™ Stem Cell Therapy While Advancing Preparations for Phase III COVID-19 Clinical Trial (yahoo.com)
² Therapeutic Solutions International Identifies and Files Patent on Novel Mechanism of Action of Its FDA Phase III Cleared JadiCell™ Treatment of COVID-19 and Delta Variant (prnewswire.com)
³ Therapeutic Solutions International Identifies Novel Biological Pathway Utilized by its Phase III Adult Stem Cell Product JadiCell™ to Stimulate Healing of Injured Lung Tissue | Business Wire
⁴ Therapeutic Solutions International Announces Launching of Phase III Clinical Trial for Treating COVID-19 Lung Damage Using its JadiCell™ Universal Donor Stem Cell Drug | BioSpace
⁵ Review of TSOI’s COPD Therapy Moves Forward With IND Designation (copdnewstoday.com)
⁶ Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using Clinically Validated JadiCell® Universal Donor Stem Cell (prnewswire.com)
⁷ Therapeutic Solutions International Develops Novel Stem Cell Based Therapy to Reduce Lung Scarring: Potential Solution to Post COVID-19 Lung Deterioration (prnewswire.com)

View source version on businesswire.com: https://www.businesswire.com/news/home/20220718005434/en/

Timothy G. Dixon

ir@tsoimail.com

Source: Therapeutic Solutions International, Inc.

FAQ

What is the significance of Emergency IND #28685 for TSOI?

The Emergency IND #28685 allows Therapeutic Solutions International to provide JadiCells to patients with advanced COVID-19 ARDS outside its ongoing Phase III trial, addressing urgent healthcare needs.

How many patients has TSOI treated under expanded access for JadiCells?

Therapeutic Solutions International has successfully treated 15 patients under expanded access provisions using JadiCells.

What are the next steps for Therapeutic Solutions International regarding JadiCells?

Following the FDA's approval, TSOI will focus on expanding the availability of JadiCells to patients in need, while continuing its Phase III clinical trial.

What other conditions are being targeted by TSOI's JadiCells?

In addition to COVID-19 ARDS, JadiCells are also being developed for conditions like COPD and Chronic Traumatic Encephalopathy.