New Data Covering Optimized Immunological Adjuvants Filed in Patent as Company Moves Towards FDA IND Application
PR Newswire
ELK CITY, Idaho, May 24, 2021
ELK CITY, Idaho, May 24, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today new data demonstrating synergy between the Company's tumor blood vessel killing vaccine, StemVacs-V iPSC and specific immunological adjuvants.
The data is part of a package being developed that the Company will send to the Food and Drug Administration (FDA) as part of its planning for an Investigational New Drug (IND) filing. Additionally, the data was incorporated in a patent application filed today.
"The utilization of the immune response to selectively kill tumor blood vessels was demonstrated by Companies such as Batu Biologics, who obtained FDA clearance to stimulate immunity in patients using placentally derived material1. Additionally, published human and animal data showing signals of efficacy and safety using the first-generation approach2,3" said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International and co-inventor. "Unfortunately, previous approaches were characterized by need for multiple donors and the possibility of batch-to-batch variation. The StemVacs-V iPSC product represents a second-generation vaccine which utilizes only one donor and is being optimized to induce superior potency and reproducibility."
StemVacs-V iPSC is a cellular product generated from a standardized inducible pluripotent stem cell (iPSC) which is differentiated into cells that resemble blood vessels which feed the tumor. Additionally, StemVacs-V iPSC expresses the alpha1,3-galactosyltransferase gene which causes the cells to express to Gal alpha 1-3Gal beta-4-GlcNAc (alpha Gal). Alpha Gal is one of the most potent immune stimulating molecules in nature, evoking one of the most powerful immune responses known to man.
"We have learned from our previous experiences, as well as the experiences of our colleagues, that inducing permanent remission of tumors will not occur through a "magic bullet" approach" said Famela Ramos, Vice President of Business Development. "Accordingly, we and our collaborators have identified several synergistic approaches, for which we have filed intellectual property, that will increase our chances of optimal therapeutic outcome once we enter clinical trials."
"At Therapeutic Solutions International we are constantly seeking to perfect our therapeutic approaches because we are realistic. Many times, cancer therapeutics that work in mice do not work in humans but you have to start somewhere" said Timothy Dixon, President and CEO of the Company and co-inventor. "This is why we strive to perfect the efficacy of our approaches as much as possible in preparation for clinical trials. We are committed to making a meaningful impact in the lives of cancer patients."
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 Batu Biologics Receives FDA Clearance for First Multi-Pronged Immunotherapy Targeting the Blood Vessels that Feed Cancer | Business Wire
2 Induction and characterization of anti-tumor endothelium immunity elicited by ValloVax therapeutic cancer vaccine | Oncotarget
3 Safety of targeting tumor endothelial cell antigens | Journal of Translational Medicine | Full Text (biomedcentral.com)
View original content:SOURCE Therapeutic Solutions International
