¿ Abbott Laboratories, of Abbott Park, Ill., reported Phase II trial data for the protease inhibitor ABT-378/r (lopinavir/ribonavir) at the 13th International AIDS Conference in Durban, South Africa. In two ongoing studies, the product continued to suppress HIV at 72 weeks both in new patients and in patients who had failed other therapies. In June, Abbott submitted a new drug application to the FDA for the product.
¿ Agouron Pharmaceuticals Inc., of La Jolla, Calif., reported that, in a long-term study, a majority of people living with HIV who received Viracept (nelfinavir mesylate, FDA-approved) combination therapy for three years in a clinical trial experienced suppression of virus as well as replenishment of CD4 cells. Agouron is a wholly owned subsidiary of Pfizer Inc., of New York.
¿ Hemispherx Biopharma Inc., of Philadelphia, is planning a Phase II/III HIV trial of Ampligen in Europe in light of new data suggesting that multidrug resistance to anti-HIV drugs is a bigger problem than previously thought. A Phase II/III U.S. study already has been designed to use the drug in an effort to salvage/rescue antiviral benefits from combination therapies to which HIV can develop resistance.
¿ Hollis-Eden Pharmaceuticals Inc., of San Diego, presented Phase I/II data for HE2000, indicating statistically significant increases in key immune system cells in 37 patients. The South African trial is ongoing, with additional follow-up data expected to be reported at future meetings.
¿ Vertex Pharmaceuticals Inc., of Cambridge, Mass., reported positive preliminary results suggesting that adding a low dose of ritonavir boosts blood levels of the company's Agenerase (amprenavir). Ritonavir is under development at Abbott Laboratories, of Abbott Park, Ill. Both products are anti-HIV protease inhibitors. Agenerase is partnered with Glaxo Wellcome plc, of London.