INGN 241 Shows Clinically Significant Activity in Advanced Cancer

Introgen Therapeutics has reported the publication of data from a Phase I trial of INGN 241 in patients with solid tumors.

These data demonstrate that direct injection of INGN 241 induced programmed cell death in 100 percent of the tumors treated, even in patients who had failed prior therapy with other anticancer drugs. Clinical responses were observed in 44 percent of the treated lesions, including complete and partial responses in two patients with melanoma. Patients treated with INGN 241 had increases in a subset of T-cells that help to destroy cancer cells, which is consistent with the role of MDA-7 protein as a member of the interleukin family of immune stimulating proteins. MDA-7 is the active component of INGN 241.

The results appear in two papers in an issue of Molecular Therapy. The Phase I dose-escalation study treated 22 patients with advanced solid tumors. All patients had previously been treated for cancer, and the majority had received surgery in addition to chemotherapy or radiation therapy. A total of 15 different tumor types were treated, including melanoma, breast, colorectal, non-small cell lung cancer and lymphoma.

The data from these patients indicate that INGN 241 is well-tolerated, and a maximum-tolerated dose was not reached. Two of five patients treated at the highest dose showed objective clinical responses, including complete regression of one treated lesion in a patient with melanoma. Immune activation was noted in these patients along with molecular changes that mirrored preclinical studies.