RAC passes Introgen gene therapy trial

The Recombinant DNA Advisory Committee (RAC) completed its review of Introgen's Phase III trial protocol for INGN 201 adenoviral p53 gene therapy to treat head and neck cancer. The company said this was the first Phase III registration protocol to pass the RAC review process. The study, which will be conducted in the U.S., Canada and Europe, is expected to enroll 240 patients with refractory head and neck cancer. Introgen is partnered with Aventis.

Last month, Rep. Henry Waxman (D-Calif.) questioned what he called the "high mortality" rate in the company's Phase I trial of INGN 201 in lung cancer patients. At that time, Introgen CEO David Nance said Waxman had deliberately "misrepresented the facts." (see BioCentury Extra, Feb. 25). According to Nance, none of the deaths were classified by investigators as definitely or probably being caused by the product. ...