• 4/22/2004
  • Austin, Texas

Recent preclinical studies provide new insight into the molecular pathways by which p53, the active component of Introgen Therapeutics’ (NASDAQ: INGN) Advexin therapy, kills tumor cells. These preclinical studies were undertaken in order to provide additional molecular data supporting the clinical benefit observed during the clinical development of Advexin, now in phase 3 trials for the treatment of head and neck cancer. The studies were conducted by Introgen’s collaborators at Okayama University in Japan and at The University of Texas M. D. Anderson Cancer Center and were published earlier this year in an issue of Molecular Cancer Therapeutics. Introgen has previously sponsored studies in Japan which include a phase 1-2 trial in non-small cell lung cancer and a phase 2 trial in esophageal cancer.

These recently reported findings add substantially to our knowledge of the timing and expression levels of p53 and genes that are activated by p53 protein after the delivery of Advexin therapy. The p53 protein and gene functions as a tumor suppressor by arresting cell growth, inducing programmed cell death, causing cancer cells to differentiate, and inhibiting the growth of new blood vessels required to support tumor growth. Preclinical and early clinical studies with Advexin have shown that delivery of the p53 gene to cancer cells can provide therapeutic benefit by reducing tumor volume, halting tumor growth, and improving survival. The current study provides additional information regarding the specific pathways that mediate the observed therapeutic effects of Advexin.

Lou Zumstein, Ph.D., Introgen’s director of research said, “These studies provide additional evidence supporting Advexin’s ability to attack cancer cells through multiple molecular pathways. The additional information about the timing, duration and persistence of expression of p53 and genes activated by p53 following Advexin administration may help us to further optimize Advexin therapy. Additionally, quantifying the expression levels of genes that are activated by p53 protein may help to identify other candidates for gene-based cancer therapy.” Introgen is a leading developer of biopharmaceutical products designed to induce therapeutic protein expression using non-integrating gene agents for the treatment of cancer and other diseases. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates a commercial-scale, CGMP manufacturing facility.