Introgen Therapeutics announced a phase 1/2 study with its leading cancer drug candidate Advexin has been initiated in which Advexin is being administered in the form of an oral rinse, or mouthwash, for oral premalignancies. The study is being conducted under a previously announced clinical trials agreement between the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) and Introgen Therapeutics to co-develop Introgen's p53-based cancer agent Advexin. This is the first trial to investigate the effect of Advexin on oral lesions that are at high risk for developing into full-blown cancers.
Dr Robert E Sobol, Introgen's senior vice president of medical and scientific affairs said, "Positive clinical data from more than 20 clinical studies with Advexin provided the basis for evaluating the therapy in earlier stages of the development cycle of cancer growth. One of our goals is to treat earlier stage disease, even prevent disease if possible, in the hopes of improving outcomes for cancer patients."
Patients with premalignant lesions will be treated for up to six months with Advexin delivered as an oral rinse. Once inside precancerous cells, Advexin leads to the expression of high levels of p53, a protein that plays a central role in the normal pathways that cause damaged cells to undergo apoptosis (also known as cell suicide). Apoptosis is a normal process the body uses to eliminate damaged cells, precancerous cells and cells that are no longer necessary. Known as a tumor suppressor, p53 provides a powerful halt signal on cell growth. One of the major roles of this protein is to recognize when the cell has been damaged by mutation and to stop cell growth until the damage is repaired. If the cell is heavily damaged and beyond repair, p53 initiates the cell death pathway to prevent the cell from growing out of control.
Tobacco smoking and alcohol use are contributing factors to the development of oral cancer and the American Cancer Society estimates that in 2003 more than 180,000 cancer deaths are expected to be caused by tobacco use. It is estimated that 30,000 new cases of oral cavity cancer occur annually. Cancers of the oropharynx occur in approximately 4,000 patients annually in the United States.