Introgen Therapeutics, Inc. announced the initiation of a Phase 2 clinical trial of INGN 241 in patients with metastatic melanoma. Mda-7/IL-24, the active component of INGN 241, is a novel tumour suppressor gene that also exhibits tumour-selective apoptosis, immune-stimulating and angiogenesis inhibiting activities. INGN 241 has completed a Phase 1 clinical trial in a variety of cancers.

"Clinical activity of INGN 241 in the treatment of melanoma has been demonstrated in a previous clinical study in which significant regression of multiple tumours was observed after treatment," said Sunil Chada, Introgen's director of research and development. "The MDA-7/IL-24 protein has multiple anti-cancer activities, including tumour suppression, stimulation of the immune system and inhibition of the growth of new blood vessels necessary to support tumour growth. These activities may lead to regional and systemic anti-tumour effects. Previous results in patients with metastatic melanoma are very encouraging and suggest INGN 241 may have utility in this disease, which is difficult to treat."

The Phase 2 trial is designed to enroll up to 25 metastatic melanoma patients with at least three regional lesions. The primary objective of this study is to determine if intratumoural injection of INGN 241 can exert regional and systemic biologic activity. Secondary objectives include analysis of toxicity, tumour response and induction of specific immunity against the melanoma tumours. The study is being conducted at The University of Texas M. D. Anderson Cancer Center.

"We are very interested in evaluating the effect of INGN 241 on metastatic melanoma lesions," said Kevin Kim, M.D., Assistant Professor of Medicine in the Department of Melanoma Medical Oncology at The University of Texas M. D. Anderson Cancer Center and the trial's principal investigator. "Currently available chemotherapy regimens for metastatic melanoma do not significantly improve median survival. The addition of biologics to these chemotherapy regimens results in only a five to 20 per cent complete response rate. Moreover, many metastatic melanoma patients cannot tolerate the existing regimens. Metastatic melanoma patients have great, unmet medical need for therapies that are active against their disease and have favorable safety and tolerability profiles. This trial will help us assess the potential for INGN 241 as a new approach to treating malignant melanoma."

According to the American Cancer Society 55,100 new cases of melanoma will be diagnosed and 7,910 people will die of melanoma in 2004 in the United States alone.