Moffitt doctors get positive study results for patients with lung cancer

February 21, 2006

Tampa, FL -- In a trial conducted by researchers at the H. Lee Moffitt Cancer Center & Research Institute and Introgen Therapeutics, Inc. (NASDAQ:INGN) results proved positive for patients with advanced lung cancer. Following INGN 225 treatment and chemotherapy, 62 percent of patients demonstrated tumor responses to immunotherapy. INGN 225 is an investigational p53 based immunotherapy. Historically, response rates to second line chemotherapy in this disease range from only five to 25 percent. Similar patients with this type of lung cancer do not have a good prognosis and most live less than six 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,” says principal investigator Dr. Dmitry Gabrilovich. Moffitt’s Dr. Scott Antonia served as co-principal investigator on the study.

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,” says Dr. Robert E. Sobol, Introgen's senior vice president of Medical and Scientific Affairs.

The American Cancer Society supported the trial with a grant. The data appear in the February 1 issue of Clinical Cancer Research, one of the premier journals in the field of cancer research. INGN 225 is also being evaluated in a Phase I/II trial in patients with breast cancer.

About H. Lee Moffitt Cancer Center & Research Institute

In 2001, the National Cancer Institute awarded Moffitt the status of a Comprehensive Cancer Center in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country’s leading cancer centers, and is listed in the U.S. News & World Report as one of the top cancer hospitals in America. Moffitt’s sole mission is to contribute to the prevention and cure of cancer.

About Introgen Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle tumor suppressor therapies to treat a wide range of cancers using tumor suppressors, cytokines and genes. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility. Introgen controls a growing portfolio of over 300 patents and applications directed to various applications of gene based treatment, combination treatments and process/production of gene based agents and nanoscale delivery systems.