• 4/9/2002
  • San Francisco
  • American Association for Cancer Research

Recurrent head and neck cancer patients receiving higher dose of ADVEXIN® gene therapy in one study had a significant survival advantage when compared to a group of patients in another study receiving a lower dose of the drug, according to the results of two Phase 2 studies presented today at the annual meeting of the American Association for Cancer Research.

Study results show that, for the first five months of the trial, patients in the ADVEXIN high-dose study were 50 percent more likely to live than those in the low-dose study. ADVEXIN, which combines a proprietary adenoviral vector with the p53 gene, is the lead product candidate of Introgen Therapeutics, Inc. (NASDAQ: INGN).

“We are extremely encouraged by these results demonstrating a significant survival advantage in patients who received a high dose of ADVEXIN,” said Max W. Talbott, Ph.D., Introgen’s senior vice president of worldwide commercial development. “There have been drugs approved to treat cancer that demonstrated a less beneficial survival advantage in clinical trials.”

Patients receiving high-dose ADVEXIN had a median survival advantage 2.4 months longer (189 days vs. 114 days) than those receiving a low-dose treatment with the drug. Dosing in the low-dose study was 50 times lower than dosing in the high-dose trial. Dosing in the high-dose trial was consistent with dosing in Introgen’s current phase 3 studies of ADVEXIN in the treatment of head and neck cancer.

Data from the same studies also show a 60 percent improvement in the cancer cell death rate and an 88 percent improvement in median survival among patients in the high-dose trial.

All patients in both studies were treated with intratumoral injections of ADVEXIN alone. The two studies at 34 centers worldwide treated a total of 166 patients with recurrent head and neck cancer who were ineligible for surgery because of the severity of their cancer. A median number of two treatment cycles was received in each study. The most frequently reported side effects were fever/chills and injection site pain/hemorrhage with a higher proportion of fever and chills in the higher dose range. There were no blood, kidney, or liver toxicities observed in patients in either study.

“These findings suggest a potential role for the use of this novel gene-based therapy in the treatment of patients with head and neck cancer and justify ongoing phase 3 trials,” said John Nemunaitis, M.D., associate director of clinical research at U.S. Oncology and principal investigator of the studies. “The large size of these Phase 2 studies and the fact that ADVEXIN was used as a single agent give weight to these data.”

Introgen is currently enrolling head and neck cancer patients in two ongoing pivotal phase 3 trials at 60 centers worldwide as part of the registration program for ADVEXIN. The two randomized, controlled trials, which will involve more than 500 patients, are ongoing. The primary endpoint in one trial is disease progression and the primary endpoint in the other is overall survival. More information about Introgen’s clinical trials can be obtained by e-mailing Introgen at clinicaltrials@introgen.com or by calling the company toll-free at 1-866-631-4646.

ADVEXIN, formerly designated by Introgen as INGN 201, is a patented cancer therapeutic incorporating the p53 tumor suppressor gene in an adenoviral delivery system. ADVEXIN is designed to use the p53 gene to kill cancer cells and to stop tumor growth, without harming normal cells, in cancer patients with both normal and damaged p53 genes. The p53 gene interferes with cancer cells because it is a tumor suppressor gene and carries instructions to make a protein that reacts with the damaged DNA of a cancer cell. Specifically, the p53 protein activates one of two pathways in these cells, to either stop growth by “hibernating” the cell or induce death via a process of programmed cell death, called apoptosis. Both processes provide an important brake to the development of certain cancers.

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