Clinical studies using PolyICLC with Dr. Salazar of Walter Reed include three diseases. 1) Preliminary studies with AIDS. There are currently 35 patients who have been entered into the first phase of the work determining the best dose and schedule. Detailed analysis of lymphocyte subsets showed that there are transient rises in a number of subsets after injection of polyICLC. This effect lasts for one or two days, and then the value reverts to pretreatment levels. We have started a number of patients on polyICLC alone, without AZT, 3 times a week, at a low dose. There was one death in this group of six, a patient who had pneumocystis before starting treatment and who died a week after starting treatment. There have been no opportunistic infections in this group, but this schedule has been ongoing only 4 months. 2) The work with multiple sclerosis is developing to the point where a randomized double-blind trial may be considered. Patients receive low doses of the drug 2 or 3 times a week. There are minimal side effects, and the patients either remain stable or improve slightly. The first patient with neurologic disease, who was put on polyICLC nine years ago, made a dramatic improvement. He was treated for seven years. Starting with complete paralysis, after treatment for three months he was able to go home, complete his education, get a job, and get married; however, he experienced recurring weakness about every 5-6 weeks and needed polyICLC treatment. Now, he has been off the drug for 1.5 years and remains well. 3) Five glioma patients are being treated with polyICLC plus CCNU in an adjuvant setting. One of the five died after a year; the others are still alive. USAMRIID has initiated a formal plan to treat normal volunteers prophylactically with polyICLC to test its efficacy against exotic virus infections of military importance.
