To: tuck who wrote (807 ) 6/26/2003 10:55:39 AM From: Jibacoa Read Replies (1) | Respond to of 1005 And again today after this:biz.yahoo.com AUSTIN, Texas, June 26 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - News) announced that treatments have been initiated in patients using its novel anti-cancer vaccine known as INGN 225. INGN 225 uses Introgen's Advexin drug in a new way to create a highly specific therapeutic cancer vaccine. Previously published pre-clinical data demonstrated that 60 percent of animals treated with INGN 225 were protected against tumor development. When dendritic cells were activated, 100 percent protection against tumors was achieved. "This is an exciting progression of our effort to find viable vaccines against cancer," said Dmitry Gabrilovich, M.D., Associate Professor of Oncology at the H. Lee Moffitt Cancer Center. "This clinical study will allow us to test the principles we validated in preclinical studies that INGN 225, which uses the p53 gene, has utility in inducing the immune system to attack cancer cells." The phase 1/2 study is being conducted at the H. Lee Moffitt Cancer Center, in Tampa, Fla., by principal investigators Dr. Scott Antonia, in the department of thoracic oncology and Dr. Dimitry Gabrilovich in the department of immunology. The study is enrolling patients with small-cell lung cancer, who first receive a standard treatment of chemotherapy, followed by INGN 225. The goal of the study is to demonstrate the safety of the treatment and the anticancer potency of the vaccine. The study is also designed to monitor the length of time that the patient's cancer is kept from progressing. The INGN 225 vaccine was developed based on work by Dr. Gabrilovich and by Dr. David Carbone, professor of oncology at The Vanderbilt-Ingram Cancer Center. Extensive preclinical testing from Introgen, its collaborators, and many independent scientists has shown that the immune system can recognize and respond to tumor associated p53. Introgen and its collaborators have demonstrated that induction of p53 immunity is safe in animal models. "p53 mutations and alterations are a hallmark of cancer cells, and this strategy has successfully killed cancer cells throughout the body in preclinical models," said Dr. James Merritt, Introgen's chief medical officer. "Thus, we believe a vaccine which employs p53 will likely have broad utility in the clinic." To create the vaccine, Advexin is used to stimulate the patient's dendritic cells, which are then used as a therapeutic vaccine to repeatedly immunize a patient against their cancer. This study represents the first time that a natural tumor suppressor molecule such as p53 has been used in patients as a vaccine. Dendritic cells are a key orchestrator of the immune response and are specifically responsible for activating the human immune system against specific "invaders," such as cancer cells. The actual killing of these targets is performed by lymphocytes known as CTLs or cytotoxic T lymphocytes. Simply put, dendritic cells present images of the cancer cell to T-lymphocytes and educate them to recognize tumor cells. These T-cells seek out cancer cells and kill them, functioning as a 'smart bomb' to selectively eliminate its cancer cell target throughout the body. Efficiently and specifically harnessing the power of CTLs has been a long sought goal of cancer immunology. RAGL Bernard