DuPONT's CURRENT AMPLIGEN PRODUCTION WILL SUPPLY UP TO 5,000 PATIENTS

Executive Summary

DuPONT's CURRENT AMPLIGEN PRODUCTION WILL SUPPLY UP TO 5,000 PATIENTS in expanded clinical trials, DuPont Pharmaceuticals and Biotechnology R&D Director Joseph Mollica told the Presidential AIDS Commission's Feb. 19 meeting in New York City. In an update on the status of the antiviral agent jointly being developed by DuPont and HEM Research, Mollica told the commission that production of Ampligen "is being increased to a maximum capacity to support about 5,000 patients, enough for trials, but not enough for commercialization." DuPont is planning to scale up its own production capability for further trials and "possible commercialization" in approximately two-and-a-half years. In the meantime, the firm has approached other manufacturers to contract out individual segments of the production, Mollica said. Ampligen is currently being produced in lab scale quantities of less than 10 kg per year, enough for only a few hundred patients, according to Mollica. Since DuPont signed its agreement with HEM in October, a multicenter, double-blind, randomized trial in male patients with ARC has been accelerated. The study is underway at centers in New York, Philadelphia, Washington, D.C., Atlanta, Houston, and Miami. The trial is expected to be completed in one year, Mollica said.