• 9/11/2006
  • Palm Beach Gardens, FL
  • press release
  • biz.yahoo.com

The Cancer Cure Coalition announces its support for the nomination of Dr. Andrew Von Eschenbach as Commissioner of the U.S. Food and Drug Administration and calls for the approval of Advexin, a new gene therapy treatment for cancer. We believe it critical that a permanent director be in charge of this vitally important agency and that he has the special experience and ability required to deal with the complex problems confronting it.

For too long this agency has lacked a permanent director and this has led to a slow down in its decision making and fearfulness to approve breakthrough treatments. This is holding back important new treatments for life threatening illnesses, especially those for cancer.

One major example of this is the delay in approving Advexin, a P53 gene tumor suppressor now in U.S. Phase III clinical trials. Although the clinical trials are only for head and neck cancer this gene therapy has already shown its ability to successfully treat many other types of cancer including most recently breast cancer.

The P53 gene is naturally present in the body and stops cell division when DNA damage occurs. When the P53 gene does not function normally genetic mutations can occur leading to potential cancer growth. What makes this treatment even more promising is the recent development by Genzyme Corp. of a new diagnostic test that detects specific mutations in the P53 gene. This allows the gene therapy treatment to be targeted to those patients most likely to respond.

What is especially troubling about the FDA’s delay in approving this therapy is that a similar gene therapy was approved in China three years ago and is now being used to treat many types of cancer. Some doctors view this gene therapy as a scientific breakthrough comparable in importance to the discovery of penicillin.

We believe there is reason to be concerned about our country falling behind other nations in the development and use of new therapies. This is causing economic harm to our country as well as deficiencies in our treatment of critically ill patients forcing some patients to seek treatment outside of the United States.

“This is a wake up call to America,” said Mark Kay, president of the American Society of Gene Therapy and Director of The Stanford University School of Medicine. “We need to look at some of the regulatory hurdles, and the funding issues right now, funding for biomedical research is really hurting, and it’s short sighted to think this doesn’t hurt our economy in the long run.”

The Cancer Cure Coalition is looking forward to Dr. Von Eschenbach leading the FDA in finding ways to streamline its regulatory processes to make them more efficient and to respond to the opportunities and challenges of science and technology.