Trial Information

Phase II Study Examining the Biological Efficacy of Intratumoral INGN 241 (Ad-mda7) Administration in Patients With In Transit Melanoma

INGN 241 is an adenoviral vector carrying the MDA-7 cDNA. MDA-7 is a novel tumor suppressor
molecule with cytokine properties, recently designated as IL-24. Over expression of MDA-7 in
melanoma cells in vitro has been shown to inhibit cellular proliferation and induce
apoptosis. Loss of MDA-7 expression in human melanomas has been shown to correlate with
invasion and metastasis. The INGN 241 gene transfer construct has been previously used in
human subjects in an ongoing open label Phase I study using intratumoral administration, and
has been well tolerated to date. The primary objectives of the present study are to
determine if INGN 241, injected into a melanoma in transit lesion, can induce apoptosis in
regional uninjected lesions and initiate systemic immune activation. Secondary objectives
include examination of specific immunity and of clinical response and toxicity.