Introgen Therapeutics Inc announced that direct intrabronchial instillation of its p53 drug Advexin is remarkably safe and shows evidence of therapeutic activity in cancer patients with bronchoalveolar lung carcinoma. These data were presented during the annual meeting of the American Society of Clinical Oncology by Introgen's collaborator Dr. David Carbone of The Vanderbilt-Ingram Cancer Center. The phase 1 study was conducted by the Eastern Cooperative Oncology Group under Introgen's Cooperative Research and Development Agreement with the National Institutes of Health.

"In view of previously reported activity of Advexin monotherapy and Advexin radiotherapy combination treatment for advanced lung cancer, this report of clinical activity with yet another method of delivering Advexin is encouraging" said Dr. Carbone.

In the phase 1 study, 26 lung cancer patients were treated with Advexin which was delivered via repeated instillations into the bronchial passages, known as bronchoalveolar lavage. (Abstract # 2492) The therapy was well tolerated in all patients and improved ability to breathe was noted in 20 percent of the patients who were able to be evaluated. Shortness of breath is a frequent problem in this form of lung cancer. The majority of the patients' disease stabilized and the cancer did not continue to grow. One patient had a partial response as demonstrated by x-ray. Most patients whose disease stabilized in the area for the lung treated with Advexin experienced progression of disease in untreated areas of the lung, suggesting that Advexin was active only in the treated lobes. However, one patient was reported to have had objective shrinkage of metastatic disease in two distant sites, including the brain, raising the possibility that local instillation could have more systemic effects.

"We are beginning to study treatment with Advexin in earlier stages of cancer, in combination with other modalities such as surgery and radiotherapy," said Dr. James Merritt, Introgen's chief medical officer. "We have shown previously that Advexin is active as an intratumoral injection in advanced lung cancer. Based on this report we envisage treating early lung cancers which cannot be injected and have to be treated by instillation into the bronchial tree," he added.

Cancers of the lung and bronchus will account for 171,900 new cases of cancer in the United States this year, according to the American Cancer Society. Bronchoalveolar lung carcinoma (BAC) is characterized by thin sheets of tumor cells growing along the pulmonary airways and is often resistant to surgery, chemotherapy and radiation.