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CCC Chairman Supports Approval of Advexin with Letter to FDADr. Andrw C. von EschenbachCommissioner, FDA Dear Dr. von Eschenbach: I am the chairman and founder of the Cancer Cure Coalition, a non-profit foundation working for the cure and prevention of cancer. Our organization is a member of the Alliance for a Stronger FDA and through it we are supporting the obtaining of adequate funding for the FDA. I have recently been nominated to serve on the board of directors of the Alliance and am looking forward to being of help in that regard. The Cancer Cure Coalition was a strong supporter of your approval as commissioner of the FDA and stated in a Press Release that we believe you have “the special experience and ability required to deal with the complex problems confronting it.” I am writing you in support of the approval of an anti-cancer therapy called Advexin, a P53 gene therapy, that was recently submitted to the FDA for approval. This is the first time an application for a gene therapy product has been made to the FDA. An application has also been made to the European Medicines Evaluation Agency. It is possible to identify those patients who lack an adequate amount of the P53 gene. The clinical trial before the FDA showed that those patients strongly benefit from Advexin. Their tumors regressed and Advexin did it. More than that, it is significantly better than Methotrexate, a highly toxic chemotherapy that is now the commonly used treatment. In addition to the clinical trial, there is other supportive evidence for Advexin. A comparable product called Gendicine was approved in 2003 in China and it has since been widely used there. It shows both efficacy and safety. As reported at the European Society of Gene and Cell Therapy (ESGCT) in Rotterdam in October 2007: “The presentation of post-clinical trials results at the ESGCT Congress marks a watershed moment for Gendicine and for the global fight against cancer, stated Yiqinq Wan, Brenda CEO. “the international; medical community will learn what thousands of cancer patients already know a revolutionary, potentially highly effective cancer treatment is available today in China in the form of Gendicine.” “Encouraged by the demonstrated effectiveness of Gendicine®, approximately 1,800 foreign patients have already traveled to China for Gendicine® treatment. As molecular biologist Masatoshi Tarawa, of Japans Chiba University, commented during a recent “Chemistry World” interview, “the results will encourage cancer patients and they are asking for any kind of possibility to survive.” It is thought by many that Gendicine was based on the work done here in the United States by Introgen. We believe that this additional evidence of actual use with patients, combined with the clinical trial results, is strong evidence for the approval of Advexin and that cancer patients would greatly benefit from it. Doctor, I am looking forward to serving on the Alliance for a Stronger FDAs board of directors and hope that I will have the opportunity to meet you at some time. Sincerely,Charles A. Reinwald Charles A. Reinwald Chairman Cancer Cure Coalition
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