Development of a Gene Therapy Trial for Metastatic Prostate Cancer

Abstract

This award was to support the infrastructure and development of a Phase I clinical trial for men with metastatic prostate cancer. The Phase I trial under development employs a prostate restricted replicative adenovirus (PRRA) with excellent preclinical performance in vitro and in vivo in relevant animal models of human prostate cancer. Several components of the statement of work for this award have been completed. The key component of this trial the PRRA AdIU1 required a slight modification before proceeding with implementation of the trial as submitted. Reconfirmation of the activity of the modified AdIU1 was required prior to moving forward with the clinical trial. A majority of the funding from this award remains in the CTDA account and a no cost extension has been requested to allow continued development of the trail in order to apply for a 2007 DOD Clinical Trial Award to initiate a trial in 2008. Currently with the clinical trial team in place and modified AdIU1 verified the regulatory applications on hold can be filed.

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Document Details

Document Type
Technical Report
Publication Date
Jul 01, 2006
Accession Number
ADA473358

Entities

People

  • Thomas A. Gardner

Organizations

  • Indiana University

Tags

DTIC Thesaurus Topics

  • Adenoviruses
  • Biological Sciences
  • Cell Line
  • Cell Physiological Processes
  • Chemistry
  • Clinical Trials
  • Diseases And Disorders
  • Gene Therapy
  • Indicator Dyes
  • Infection
  • Medical Personnel
  • Neoplasms
  • Programmed Cell Death
  • Prostate
  • Prostate Cancer
  • Tissues
  • Viruses

Readers

  • Clinical Trial Research.
  • Oncology (Cancer Research).

Technology Areas

  • Biotechnology
  • Biotechnology - Cancer Biotech