StemVacs Cancer Vaccine Shows Safety in Phase 1 Study and May Be Eligible for Right to Try, Therapeutic Solutions Says

StemVacs Cancer Vaccine Shows Safety in Phase 1 Study and May Be Eligible for Right to Try, Therapeutic Solutions Says

StemVacs, a cell-based immunotherapy vaccine platform that targets cancer stem cells, was well-tolerated by 10 patients with multiple advanced cancers who took part in a Phase 1 safety trial, the therapy’s developer, Therapeutic Solutions International, announced in a press release.

It also claimed that some patients showed evidence of tumor stabilization and immune system activation, and announced plans to possibly promote StemVacs use in gravely ill patients in the U.S. under the new Right to Try law. The release did not identify or describe the trial cited, other than to suggest it took place at a treatment center located in Tijuana, Mexico.  

The experimental treatment, administered as an under-the-skin injection, consists mostly of lab-grown dendritic cells — immune “sentinel” cells named for their tree-like shape — that are designed to activate the immune system to selectively target and kill pathogens that include cancer stem cells. The latter are thought to play key roles in tumor formation, metastasis, and cancer relapse.

Dendritic cells (DCs) are sometimes comprised in their ability to work as intended in cancer patients, because cancer cells produce molecular factors that prevent dendritic cells from becoming fully active.

StemVacs vaccine was developed to deliver cancer patients with active DCs, increasing the likelihood they will initiate attacks on cancer stem cells to halt tumor growth.

“Through our collaborators at the Pan Am Cancer Treatment Centers, we have been able to successfully administer the StemVacs cellular cancer immunotherapeutic to 10 patients with various types of advanced cancers. We have observed no treatment-associated adverse events, and in some cases, stabilization of tumors and stimulation of immunity were observed and noted,” Timothy Dixon, president and CEO of Therapeutic Solutions International, said in the release.

“This Phase I safety data strongly supports our continued clinical development of StemVacs, of which part of the development pathway includes providing patients access to it now under the Right to Try Law.”

“Immunotherapy is the greatest advancement in the area of clinical oncology,” said James Veltmeyer, MD, chief medical officer of Therapeutic Solutions International. “To our knowledge, StemVacs is the only clinical stage immunotherapeutic that kills cancer stem cells. This, combined with the safety and signals of efficacy obtained from the current Phase 1 clinical trial, support us to expand the use of StemVacs under President Trump’s recently passed Right to Try Law.”

The Right to Try Act enables terminally ill patients to try medicines that have passed the basic safety (Phase 1) trials, but have not been approved for general use by the U.S. Food and Drug Administration’s (FDA) under its multi-testing approval process.

So far, Right to Try has been approved in 41 states: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.

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