New Orleans, LA - May 21, 2000 - Introgen Therapeutics, Inc. today presented data from its clinical studies of adenoviral p53 gene therapy at the 36th American Society of Clinical Oncology (ASCO) Annual Meeting in New Orleans, Louisiana. Data presented showed promising Phase II interim results using a patented adenoviral p53 therapy in conjunction with radiation therapy for the treatment of non-small cell lung cancer (NSCLC). Additionally, the company reported comprehensive tolerance and safety data from Phase I and Phase II trials using adenoviral p53 for the treatment of squamous cell carcinoma of the head and neck (SCCHN), carcinoma of the prostate, and NSCLC. The results include data from six years of international gene therapy clinical studies representing the world's largest safety database of adenoviral p53 studies.
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 patiPage: 1 2 3 Related biology news :1
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