Therapeutic Solutions International Files Investigational New Drug Application with FDA for Cancer Blood Vessel Targeting Immunotherapy StemVacs-V to Treat Metastatic Breast Cancer

Company Developing FDA Cleared Phase III Cellular Therapy for COVID-19 Aims to Work with Regulators for Ultra-Rapid Clinical Translation

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Therapeutic Solutions International

Aug 30, 2021, 09:00 ET

ELK CITY, Idaho, Aug. 30, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to initiate a clinical trial of its StemVacs-V immunotherapy in patients with metastatic breast cancer.

On May 24th, 2021, the Company announced progress in its preclinical experiments supporting the use of the immunotherapy in human trials. Part of the experiments demonstrated superior activity of StemVacs-V to other immune system-based approaches that were cleared by the FDA to literally "choke" tumors to death by blocking their blood supply¹.

"I am honored to be leading medical efforts in bringing this game-changing approach to patients with breast cancer," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The previous efforts to develop an immunotherapy to kill tumor blood vessels have yielded drugs such as Avastin, which despite limitations, possesses multi-billion dollars in annual sales. In my opinion the StemVacs-V approach is superior to others because it induces more potent and more diverse immune responses targeting cancer blood vessels."

"The filing of today's IND is a significant milestone demonstrating the ability of Therapeutic Solutions International to rapidly move a diverse immunotherapy product pipeline through the drug development cycle," said Famela Ramos, Vice President of Business Development. "We anticipate multiple synergies of our developmental efforts as our candidate's advance forward, with our lead candidate having been cleared by the FDA to initiate Phase III clinical trials.

"Through working with our advisors such as Dr. Francesco Marincola, Dr. Santosh Kesari, and Francisco Silva, who have all published on utilization of First-Generation tumor angiogenesis blocking immunotherapies²,³, we anticipate learning from previous experiences and to rapidly move forward in taking this approach to patients," said Timothy Dixon, President and CEO of the Company and co-inventor of the StemVacs platform. "We thank our collaborators who have worked tirelessly to make this IND filing a possibility in such a rapid manner."

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, and our public forum is https://board.therapeuticsolutionsint.com/

1 Therapeutic Solutions International Optimizes Targeting the "Achilles Heel" of Cancer Using Second Generation Tumor Endothelial Targeting Vaccine StemVacs-V iPSC (prnewswire.com)
2 Safety of targeting tumor endothelial cell antigens | Journal of Translational Medicine | Full Text (biomedcentral.com)
3 Cancer anti-angiogenesis vaccines: Is the tumor vasculature antigenically unique? | Journal of Translational Medicine | Full Text (biomedcentral.com)

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SOURCE Therapeutic Solutions International