British Bio-technology Group plc said it began last week a pilotPhase I trial of its p24-VLP, an immunotherapy designed toslow or prevent the onset of AIDS in HIV-positive subjects.
The trial to test tolerability at St. Mary's Hospital in Londonrepresents the first time the compound has been tested in HIV-positive subjects.
p24-VLP is genetically engineered using BBG's virus-like-particle (VLP) technology. The injectable compound is a proteinproduced in yeast cells and is designed to stimulate immunityto the core HIV virus protein, p24.
The VLPs used in the product consist of spherical subcellularparticles formed by a self-assembling yeast protein. Theprotein is engineered to contain p24, multiple copies of whichare then displayed on the surface of the VLP. The protein,therefore, becomes highly immunogenic and mimics thestimulus of an infectious virus particle.
"We hope that immunotherapy will play an important role inthe treatment of AIDS," said the study's principal investigator,Jonathan Weber of St. Mary's Hospital. "This p24-VLP study isthe first opportunity to explore this approach."
BBG expects results from the trial by the end of 1993. If thetrial is successful, the company has scheduled further Phase IItrials of p24-VLP in several continental European centers in1993. Phase II trials will be funded by BBG of Oxford, England,which retains worldwide commercial rights to the product.
P24-VLP has been recommended by the National Institutes forAllergies and Infectious Diseases (NIAID) for evaluation in U.S.trials, also expected to begin during 1993.
-- Michelle Slade Associate Editor
(c) 1997 American Health Consultants. All rights reserved.