Introgen Therapeutics, Inc. announced that its report of final phase 1 clinical data of INGN 241 was presented during the recently held 12th Annual International Conference on Gene Therapy of Cancer in San Diego, California. The data suggests that INGN 241 therapy is safe and clinically active in cancer patients treated for solid tumours including breast, colorectal cancers and melanoma. INGN 241, Introgen's mda-7 therapeutic, is being developed for various solid tumours and is currently being evaluated in a phase 2 study.
Dr John Nemunaitis, medical director of US Oncology and principal investigator of the phase 1 trial presented the data at the conference.
"The biological activity of INGN 241 in these patients is very exciting to see," said Dr Nemunaitis. "The clinical development of INGN 241 was based on very promising preclinical data. The phase 1 study confirms that MDA-7 protein is active, and importantly, has a wide area of biological effect. MDA-7 functions not only as a tumour suppressor, but also as an immune enhancing cytokine which may be significant as a cancer drug."
The administration of INGN 241 was well tolerated in all patients and minimal toxicities were observed such as fever lasting a few hours. A key aspect of the phase 1 evaluation was to establish that intratumoural injection of INGN 241 produced the MDA-7 therapeutic protein both in local and diffusible forms and the resultant biological effects. Study results further indicate that MDA-7 protein was detectable up to 4 cm from the injection site. This wide distribution of MDA-7 protein correlated closely with apoptosis, or cancer cell killing, up to 4 cm away from the injection site, at the external edge of the injected tumour.
The laboratory of Dr Paul B Fisher, professor of clinical pathology and the Michael and Stella Chernow Urological Cancer Research Scientist in the Departments of Neurological Surgery, Pathology and Urology at Columbia University discovered the mda-7 gene. Introgen holds an exclusive worldwide license to the gene.