Brain cancer therapy OK’d for human trials

A company led by a former researcher at Kansas University Medical Center has secured federal approval to begin final human trials of a therapy the company is developing for the treatment of brain cancer.

Lenexa-TVAX Biomedical LLC, formed by Gary Wood to commercialize the therapy he developed at KU, has FDA approval to begin phase 3 clinical trials, the final step for collecting data before ruling whether the treatment is safe and effective enough to be made available for widespread public use.

TVAX intends to start enrolling patients in trials after obtaining financing. The company also is seeking money to conduct trials for a similar treatment for kidney cancer.

“Brain cancer was chosen as the first target for the TVAX treatment because preclinical studies in experimental animals and human clinical trials – which tested the treatment on very advanced brain cancers that failed other treatments – demonstrated that our approach was both safe and effective,” Wood said, in a statement.

TVAX describes its treatment as a multistep strategy that combines the resources of a patient’s own immune system with “proprietary manufacturing processes” to produce large numbers of so-called “killer” T cells, which are immune cells that specifically target a patient’s own cancer cells for destruction.

The treatment leaves normal tissue unharmed and causes minimal side effects, the company said.