Followers | 789 |
Posts | 39044 |
Boards Moderated | 15 |
Alias Born | 06/20/2009 |
![](https://investorshub.advfn.com/uicon/157766.png?cb=1465470825)
Wednesday, October 19, 2022 10:05:46 AM
NEWS 8/25/22 Therapeutic Solutions International Files with FDA to Expand ongoing Phase III Clinical Trial to Include All Causes of Acute Respiratory Distress Syndrome
https://www.businesswire.com/news/home/20220825005259/en/
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.
“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”
Tweet this
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.
Contacts
Timothy G. Dixon
ir@tsoimail.com
Recent TSOI News
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 05/31/2024 08:51:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 04:47:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/31/2024 12:46:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/31/2024 12:44:01 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/30/2024 06:46:26 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/15/2024 04:01:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 10:03:21 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 07:15:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 07:12:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/21/2024 10:25:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 11:16:15 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/08/2024 05:15:25 AM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/06/2024 11:34:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/22/2024 08:42:55 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 01/17/2024 11:15:01 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 01/04/2024 09:03:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 07:44:34 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2023 05:39:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/16/2023 11:17:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/16/2023 11:13:32 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/13/2023 06:50:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/13/2023 05:44:55 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/21/2023 09:24:52 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 08/15/2023 11:10:01 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM
Bemax Inc. Positions to Capitalize on Industry Growth with New Improved Quality of Mother's Touch® Disposable Diapers • BMXC • Jun 24, 2024 8:00 AM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM