- Austin, TX
Introgen Therapeutics Inc. said Thursday that it will soon start analyzing the data from its phase III clinical trials for Advexin, a drug to treat head and neck cancer.
The review signals that Introgen is nearing the end of its approval process for its leading product. Phase III is the last clinical trial stage and usually the most expensive and time-consuming.
CEO David Nance said the data from the phase II trials show Advexin helps patients with head and neck cancers.
“Our expanded studies show a larger number of patients with a very high statistically significant survival benefit from Advexin therapy,” said Bob Sobol, senior vice president at the Austin company.
Introgen is waiting for approval from the Food and Drug Administration before it can sell Advexin to the public. The company first applied two years ago.
Advexin is a targeted gene-based therapy intended for head-and-neck cancer patients. It uses the p53 gene, a tumor suppressor, to kill cancer cells.