Therapeutic Solutions International Inc. is planning to allow patients to access its immunotherapy drug StemVacs under the Right to Try Act after an early trial of the medicine showed safety in patients with advanced cancer.
The Oceanside, Calif.-based company said the immunotherapeutic cell-based drug StemVacs instructs the immune system to seek and destroy cancer stem cells, which are believed to be responsible for initiating the growth of tumors. Chief Medical Officer James Veltmeyer said, "to our knowledge, StemVacs is the only clinical stage immunotherapeutic that kills cancer stem cells."
The phase 1 trial, which included 10 patients with various types of advanced cancers, showed no treatment-associated adverse events. In some cases, stabilization of tumors and stimulation of immunity were observed.
The company said it plans to use the phase 1 data to allow patient access to the drug as soon as possible under the Right to Try Act. The act allows Americans with a life-threatening disease or condition to seek experimental treatments without having to go through the U.S. Food and Drug Administration's long-standing compassionate-use process.