Therapeutic Solutions International Announces Plans to Initiate Breast Cancer Clinical Trial Using FloraStilbene™ Immune Stimulator Through Res Nova Bio Subsidiary

Rhea-AI Summary

Therapeutic Solutions International (TSOI) has received Institutional Review Board approval to initiate a ten-patient proof-of-concept clinical trial. This trial aims to evaluate the efficacy of FloraStilbene™ in stimulating the immune system of advanced breast cancer patients. The therapy combines pterostilbene with RU-486 to overcome immune suppression, as evidenced by preclinical data in a mouse model.

Dr. James Veltmeyer emphasized the potential of FloraStilbene™ to enhance existing oncology immunotherapies, while CEO Timothy Dixon highlighted the commitment to addressing unmet medical needs in cancer treatment.

Positive

• Received IRB approval for a ten-patient proof-of-concept trial.
• FloraStilbene™ has shown potential in overcoming immune suppression in preclinical studies.
• Potential to enhance efficacy of existing therapies like Herceptin.

Negative

• None.

Company Receives Institutional Review Board Approval for 10 Patient Proof of Concept Oncology Trial

ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International (TSOI) announced today plans to initiate ten patient proof-of-concept clinical trial aimed at demonstrating the ability of FloraStilbene™ to stimulate the immune system in advanced breast cancer patients.

The Company has previously been granted a patent on utilization of pterostilbene and pterostilbene compositions for synergy with cancer immunotherapy such as interleukin-2¹, as well as suppression of cancer derived immune inhibitory agent enzymes such as indolamine 2,3 dioxygenase². By combining previous experiences with immune modulation, the Company announced the creation of a novel immune stimulatory adjuvant combining pterostilbene with RU-486, termed “FloraStilbene”. Preclinical data, for which intellectual property has been filed, demonstrated FloraStilbene overcame immune suppression induced in the 4T1 mouse model of triple negative breast cancer.

“FloraStilbene™ represents a non-toxic approach to overcoming breast cancer induced immune suppression, which acts as a significant barrier to efficacy of oncology immunotherapy,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “I am eager to lead this clinical trial, which if successful, will serve as the basis for a new approach to increase efficacy of drugs such as Herceptin and checkpoint inhibitors.”

“Therapeutic Solutions International has been working on, and filing patents, in the area of cancer immunotherapy with internationally renowned opinion leaders such as Dr. Santosh Kesari since 2015,” said Famela Ramos, President and Chief Executive Officer of Res Nova Bio. “We are excited to leverage these deep and broad resources to rapidly enter the clinic to address such a major unmet medical need.”

“One of the guiding principles of our Company has been to bring hope to patients for which limited options exist,” said Timothy Dixon, President, and Chief Executive Officer of Therapeutic Solutions International. “We strongly believe that immuno-adjuvant approaches such as FloraStilbene™ will greatly increase the potency of numerous existing therapies, as well as reducing various toxicities.”

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.

About Res Nova Bio, Inc.

Res Nova Bio is a San Diego Biotechnology Cancer Immunotherapy Company dedicated to addressing the unmet medical need in the treatment of advanced breast cancer. Our Company is a place where problems get solved and the lives, of our employees and our patients, are transformed. The Company's corporate website is www.resnovabio.com.

1 Augmentation of oncology immunotherapies by pterostilbene containing compositions
2 Nutraceuticals for suppressing indolamine 2,3 deoxygenase

View source version on businesswire.com: https://www.businesswire.com/news/home/20230306005481/en/

Timothy G. Dixon

ir@tsoimail.com

Source: Therapeutic Solutions International

FAQ

What is the purpose of the TSOI clinical trial?

The trial aims to evaluate the efficacy of FloraStilbene™ in stimulating the immune system of advanced breast cancer patients.

When will the TSOI trial start?

The trial is set to begin following Institutional Review Board approval.

What is FloraStilbene™?

FloraStilbene™ is a novel immune stimulatory adjuvant combining pterostilbene with RU-486.

What are the expected outcomes of the TSOI trial?

The trial aims to demonstrate the ability of FloraStilbene™ to enhance the effectiveness of existing oncology immunotherapies.

What is the stock symbol for Therapeutic Solutions International?

The stock symbol is TSOI.