Advexin(R) and INGN 225 Show Promising Results in Cancer Trials

Strategic Insights -

In a special session at the American Society of Gene Therapy 8th Annual Meeting (ASGT), Introgen Therapeutics, Inc. (INGN) highlighted the progress of its investigational cancer therapies, Advexin(R) and INGN 225. These therapies are currently being evaluated in Phase 3 and Phase 2 trials, respectively. The session, titled "The Clinical Trial Data on Ad-p53 Gene Therapy of Cancer," showcased data from multiple clinical studies demonstrating the potential of Advexin as a monotherapy and in combination with other treatments in various cancers.

Key Takeaways:

  • Advexin showed significant symptomatic improvement in swallowing in patients with esophageal cancer, with a 30% response rate (3/10 patients) in a Phase I/II trial.
  • The median survival of patients treated with Advexin in esophageal cancer was approximately 12 months, compared to historical controls with less than 10 months of survival.
  • In a multi-national, multi-site Phase 2 clinical trial of Advexin therapy in 217 patients with recurrent squamous cell cancer of the head and neck, patients treated with higher doses of Advexin showed a statistically significant increase in median survival (243 vs. 119 days) compared to those treated with lower doses.
  • A subpopulation of patients in these trials had certain defining prognostic, medical, and biological characteristics, resulting in an objective response rate of over 15%.
  • The combination of Advexin and chemotherapy resulted in objective clinical responses with greater than 50% tumor reduction in all patients with very large breast tumors.
  • Combined Advexin and radiation treatment resulted in 63% biopsy-proven complete responses at 3 months in non-small cell lung cancer patients, approximately 4 times the expected rate with radiotherapy alone.

Statistics:

  • 30% of patients with esophageal cancer showed significant symptomatic improvement in swallowing after Advexin therapy (3/10 patients).
  • Median survival of patients treated with Advexin in esophageal cancer was approximately 12 months.
  • Patients treated with higher doses of Advexin in Phase 2 clinical trials of head and neck cancer had a median survival of 243 days, compared to 119 days for those treated with lower doses.
  • Objective response rate in a subpopulation of patients participating in these trials was over 15%.

Sources:

  • American Society of Gene Therapy 8th Annual Meeting (ASGT)
  • Introgen Therapeutics, Inc. (INGN)
  • Health & Medicine Week (2005) via NewsRx.com