• 5/10/2005
  • Austin, TX
  • press release
  • Pharmalive.com

Introgen Therapeutics, Inc. is highlighted in the May 2005 issue of Nature Biotechnology in a feature story titled, “Gene Therapy: cursed or inching towards credibility?” The feature, written by Malorye A. Branca, charts the successes and challenges of developing gene based therapies.

David G. Nance, Introgen’s President and Chief Executive Officer, is quoted in the Nature Biotechnology article about the advancements in the United States in moving gene therapy products closer to approval. Introgen has recently applied for Accelerated Approval with the FDA as part of its product licensing process for ADVEXIN®, currently in two Phase 3 studies for head and neck cancer.

“As the gene therapy field continues its advances, I am reminded of the similarities with development and commercialization of monoclonal antibody therapies,” said Mr. Nance. “After much initial promise, monoclonal antibody therapies fell out of favor. Over time, however, the powerful technology was translated into products that are now an important part of standard medical care. I have no doubt that gene therapies will translate into important products, and will define an era in which medicines can be used to treat disease at the fundamental, molecular level. The Nature Biotechnology article chronicles part of the journey, illustrates how far we have come, and heralds the arrival of gene therapy as a commercial product.”

Introgen’s most advanced product development efforts have focused on gene therapy product candidates, such as the p53 tumor suppressor gene, that are clinically delivered to tumors using specially engineered adenoviruses. Adenoviruses are a common vector for the administration of tumor suppressor therapy to patients, and are used by many gene therapy companies worldwide in similar development efforts. Introgen has an established history in the manufacture of adenoviral vectors and their use in human clinical trials and controls a substantial number of United States and international patents that cover adenovirus manufacturing and purification. Introgen has complemented its manufacturing and clinical development with a strong international intellectual property portfolio including numerous patents and applications worldwide that cover each of its product candidates, such as its adenoviral p53 product candidate, ADVEXIN®, and also reflects a particular emphasis on the production and use of adenoviruses in gene therapy.