p53 Gene Therapy Product Enters Phase II Trials

Rhone-Poulenc Rorer's Gencell division and partner Introgen have startedthe first Phase II clinical trial of a gene therapy targeting p53, a gene which is mutated in over 50% of all cancers. The study will enroll around 80 patients with advanced head and neck cancer at sites in the USA, Europe and Japan.

The start of Phase II trials indicates that R-PR is happy to press ahead with development of the gene therapy, codenamed INGN 201, which is delivered via an adenoviral vector. The $50 million, 1994 agreement between the firms called for Introgen to develop the product up to Phase I, with R-PR Gencell responsible for Phase II and III trials.

European Phase I trials with the product are also planned to start before the end of the year in neoplastic ascites, colorectal cancer, hepatocellular carcinoma, and in combination with chemotherapy and radiotherapy, according to R-PR.