Targeted Genetics of Seattle, WA has begun the second leg of its study on tgDCC-E1A, a tumor inhibitory gene that is combined with radiation therapy for the treatment of head and neck squamous cell cancer.
The multi-center, open-label study will be open to adult patients with recurrent or progressive, inoperable squamous cell carcinoma of the head and neck, who have already undergone radiation therapy. Primary endpoints of the study include tumor response as measured by CT scan after 12 weeks of therapy, as well as the safety and tolerability of the gene in combination with radiation therapy.
The first part of the Phase II study was completed in May 2000 and evaluated tgDCC-E1A as a single agent. Of the 21 patients enrolled in the study, one experienced a complete response and nine others had a reduction in tumor size or stabilization of their disease, according to the company.
By AuntMinnie.com staff writersDecember 20, 2000
Copyright © 2000 AuntMinnie.com
