Introgen reports positive results for phase 2 trial of INGN 225 immunotherapy in lung cancer patients

By Elaine Rigoli

Tampa, Fla., Feb. 21 - Introgen Therapeutics, Inc. announced Tuesday the publication of encouraging data from a Phase ½ clinical study of INGN 225 in patients with advanced lung cancer.

INGN 225 is an investigational p53-based immunotherapy. Following INGN 225 treatment and chemotherapy, 62% of patients demonstrated objective tumor responses, according to a company news release.

Historically, response rates to second-line chemotherapy in this disease range from only 5%-25%. Similar patients with this type of lung cancer have a dismal prognosis and most live less than six months, but patients on this study survived for almost 12 months, the release said.

"The response rate to INGN 225 in combination with subsequent chemotherapy is significantly higher than expected. This study provides clinical support for an emerging paradigm where the effect of cancer immunotherapy can be substantially enhanced by its combination with chemotherapy," said co-principal investigator Dmitry Gabrilovich, MD, PhD, professor at H. Lee Moffitt Cancer Center & Research Institute, in a statement,

This clinical response to chemotherapy following p53-immunotherapy was closely associated with induction of p53-specific immune responses following INGN 225 administration. Importantly, 75% of patients who developed a p53 immune response had objective clinical responses, and patients with p53 immunity lived longer than those whose immune systems did not respond.

The trial was conducted by researchers at H. Lee Moffitt Cancer Center & Research

Institute and Introgen, and was supported by a grant from the American Cancer Society. The data appeared in the February 1 issue of Clinical Cancer Research.

INGN 225 is also being evaluated in a phase 1/2 trial in patients with breast cancer.

Introgen is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is based in Austin, Tex.

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