The first report is titled "A Phase II Trial of Adenoviral Mediated p53 Gene Transfer (RPR/INGN 201) In Conjunction with Radiation Therapy in Patients with Localized Non-Small Cell Lung Cancer." The poster discussion session described research conducted by Stephen Swisher, M.D. and colleagues of The University of Texas M. D. Anderson Cancer Center in collaboration with Aventis Pharmaceuticals and Introgen Therapeutics.
The study, which began in 1998, evaluated the therapeutic effect of three intratumoral injections of adenoviral p53 by either bronchoscopy or computed tomographic (CT) guidance on days 1, 18 and 32 in conjunction with a five-week course of radiation therapy in patients with inoperable lung cancer who were too ill to receive chemotherapy. The most common side effects were arrhythmia and nausea. Of the 17 patients entered to date, 29%, or 5 of 17, manifested local tumor control defined as greater than 50% regression of their total disease, and had a negative biopsy without evidence of tumor progression at any site. An analysis of the primary tumor injected with the gene therapy showed that 53%, or 9 of 17 patients, experienced greater than 50% regression of their primary tumor, and had a biopsy at the conclusion of treatment which confirmed no active cancer cells at the site treated with gene therapy. Overall, 12 of 15 patients who completed the treatment showed no active cancer in the primary tumor, suggesting considerable promise for the combined treatments. The biopsies were obtained three months after completion of treatment, displaying local tumor control that compares favorably to a control rate of less than 20% in patients treated with radiation alone.
"This study addressed the novel hypothesis that tumors injected with adenoviral p53, combined with exposure of the tumors to radiation, could improve tumor control locally," said Stephen Swisher, M.D. "Armed with trial data from the study, we can begin to apply what we've learned to manage this disease in new ways."
"Introgen is pleased to see such promising results. Our vision for this product is enhancing local tumor control in combination with other therapies to provide better response rates," said James A. Merritt, M.D., vice president for clinical affairs for Introgen. "For lung cancer, current treatments are unsatisfactory, and we are very encouraged by this combination of experimental gene therapy and standard radiation as a potential means of providing enhanced local tumor control, and ultimately longer survival times for those patients who have extensive disease not amenable to surgery."
The second presentation is titled "Tolerance and Safety of RPR/INGN 201, an Adenoviral Vector Containing a p53 Gene, Administered Intratumorally in 309 patients with Advanced Cancer Enrolled in Phase I and II Studies World-Wide," is based on international research studies that have been ongoing since 1995.
The dose escalating studies were designed to evaluate the safety and toxicity of intratumoral injection of RPR/INGN 201 in Phase I and II clinical studies for the treatment of squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC) and prostate cancer. The analysis of both clinical tolerance and laboratory parameters disclosed no trends to suggest a safety concern for this therapy. These study results strongly support advancement to Phase III trials. Introgen and Aventis are beginning Phase III studies for the treatment of head and neck cancer.
The accrual of data representing 2,296 gene therapy treatment days gives Introgen and its collaborators and the scientific community access to an invaluable resource for use in advancing gene therapy cancer research. Introgen and Aventis have shared this adenovirus safety information with the scientific and regulatory communities.
Background on Non-Small Cell Lung Cancer
An estimated 165,000 new cases of lung cancer will be diagnosed this year in the United States. Lung cancer accounts for 28% of all cancer deaths. In the United States, lung cancer is the second leading cause of death after heart disease. Because symptoms appear when the disease is already advanced, early detection is difficult, and the disease has typically spread, or metastasized at the time of initial diagnosis. Current treatments include radiotherapy, chemotherapy and surgery, however a combination of these options is most common.
Background on Squamous Cell Carcinoma of the Head & Neck Cancers of the head and neck are the fourth most common malignancy worldwide. These cancers primarily include squamous cell carcinoma of the oral cavity, pharynx and larynx. The overall rate of survival of these patients is approximately 50%. A majority of patients are diagnosed with locally advanced disease with a cure rate of only 30%. Conventional treatment for head and neck cancer patients is surgery and/or radiation. While surgery and radiation therapy can cure early stages of this disease, a majority of patients relapse, and development of a recurrent tumor is almost always fatal within one year.
Introgen Therapeutics, Inc. is a leading developer of gene therapy products for the treatment of cancer. Introgen is capitalizing on the significant advances in the understanding of the human genome and the role that gene function plays in the development of cancer. Introgen's drug discovery and development programs have resulted in innovative approaches in which therapeutic genes are used to treat cancer directly addressing the genetic abnormalities of the disease. Introgen's p53 program is being developed in collaboration with Aventis Pharmaceuticals. The companies are beginning Phase III clinical development of the p53 gene therapy for head and neck cancer. Introgen holds a US patent covering p53 used in combination with chemotherapy and radiation therapy.
Statements made in this press release about Introgen's technology and clinical trials, other than statements of historical fact, are forward looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made.
Editor's Note: This release is also available on the Internet at: http://www.introgen.com
ABSTRACT # 1807, S.G. SWISHER POSTER MAY 21, 2000 1:00 - 5:00 PM
ABSTRACT # 1806, A. YVER POSTER MAY 21, 2000 1:00 - 5:00 PM
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