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Positive Results Reported From Introgen's Phase 2 Trial of I


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Positive Results Reported From Introgen's Phase 2 Trial of INGN 225 Immunotherapy in Lung Cancer Patients

Data Published in Clinical Cancer Research

AUSTIN, Texas, Feb. 21 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN) today announced the publication of encouraging data from a Phase I/II clinical study of INGN 225 in patients with advanced lung cancer. INGN 225 is an investigational p53 based immunotherapy. Following INGN 225 treatment and chemotherapy, 62 percent of evaluable patients demonstrated objective tumor responses. Historically, response rates to second line chemotherapy in this disease range from only 5-25 percent. Similar patients with this type of lung cancer have a dismal prognosis and most live less than 6 months, but patients on this study survived for almost 12 months.

"The response rate to INGN 225 in combination with subsequent chemotherapy is significantly higher than expected. This study provides clinical support for an emerging paradigm where the effect of cancer immunotherapy can be substantially enhanced by its combination with chemotherapy. The results of this study are very encouraging and warrant continued clinical evaluation of INGN 225," said co-principal investigator Dmitry Gabrilovich, M.D., Ph.D., professor at H. Lee Moffitt Cancer Center & Research Institute. The other co- principal investigator on this study was Scott Antonia, M.D., Ph.D., associate professor at H. Lee Moffitt Cancer Center & Research Institute.

This clinical response to chemotherapy following p53-immunotherapy was closely associated with induction of p53-specific immune responses following INGN 225 administration. Importantly, 75 percent of patients who developed a p53 immune response had objective clinical responses, and patients with p53 immunity lived longer than those that did not respond immunologically. The trial was conducted by researchers at H. Lee Moffitt Cancer Center & Research Institute and Introgen, and was supported by a grant from the American Cancer Society. The data appear in the February 1, 2006 issue of Clinical Cancer Research, one of the premier journals in the field of cancer research.

INGN 225 is an investigational immunotherapy that utilizes an adenovector to deliver the p53 gene (Ad-p53) to a patient's immune cells, stimulating an anti-tumor immune response. In the study, dendritic cells were collected from each patient following the last dose of first-line chemotherapy, and treated in the laboratory with Ad-p53, to generate the INGN 225 immunotherapy. Patients with extensive stage small cell lung cancer received INGN 225 repeatedly at 2-week intervals, with most patients receiving three administrations. p53-specific immune responses were evaluated, as were objective clinical responses to the immunotherapy and subsequent chemotherapy. Induction of p53-specific immune responses were observed in the majority of patients following INGN 225 therapy.

"The accumulation of high levels of p53 protein in cancer cells relative to normal cells makes p53 an excellent target for cancer immunotherapy. The clinical data obtained in this trial is very promising and demonstrates the potential of INGN 225 to sensitize patients to the effects of commonly used chemotherapeutic agents," said Robert E. Sobol, M.D., Introgen's senior vice president of Medical and Scientific Affairs.

INGN 225 is also being evaluated in a Phase I/II trial in patients with breast cancer.

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