SYDNEY, Australia - A possible treatment for genital warts using "virus-like particles" will go into Phase IIb or Phase III trials in Australia next year, following what the scientists involved called a successful Phase I trial in China.
Ian Frazer of the University of Queensland's Centre for Immunology and Cancer Research, based at the Princess Alexandra Hospital in Brisbane, said that the recently completed Phase I trial was large enough to almost count as a Phase II trial.
He said that trial, at Wenzhou Medical College, involved more than 30 people and was designed to establish dose responses and safety. The results, to be published soon, showed the treatment to be safe. Indications of the treatment's efficacy were "sufficiently encouraging" - including strong immune responses from three-quarters of those treated - to proceed to a Phase IIb or Phase III trial in Brisbane, probably involving 120 to 150 patients. Trial details have not been finalized.
Trials of that size are expensive, but Frazer declined to specify the source of the funding for the trials.
"I'm not prepared to go on public record with the name. I don't even have to name the sponsor to the ethics committee," he said.
The virus-like particle used for the treatment is a version of the genital wart virus re-engineered through recombinant DNA techniques to provoke the immune response without causing the illness. The same technology, developed by a team led by Frazer at the hospital in 1993, is being used for other treatments being tested, including a cervical cancer treatment being developed with the help of CSL Ltd., of Melbourne.