Bionor Immuno today announced that it has advanced its efforts to develop the first HIV therapeutic immunization with the dosing of patients in a global Phase 2b clinical trial of the company's lead candidate (Vacc-4x).
This randomized, double-blind, placebo-controlled trial is being conducted in HIV infected patients with the potential to offer an important drug free break in their current antiretroviral therapy. The company anticipates that trial results will be available by year end 2009.
"The commencement of this global Phase 2b study represents an important milestone in the clinical development of our Vacc-4x therapeutic peptide candidate," said Birger Sørensen, President and CEO of Bionor Immuno. "In previous clinical studies, this peptide therapeutic candidate has demonstrated promising results in T-cell stimulation of the immune system in HIV patients. Bionor is excited to provide a potential significant step forward for treatment alternatives in the management of HIV disease."
Earlier observations of HIV patients showed that sustained immune responses to the protein p24 in the HIV virus were associated with delayed disease progression. Building on this observation, Vacc-4x is comprised of 4 modified synthetic peptides, each of which correspond to a conserved domain of the p24 protein. The modified peptides in Vacc-4x are designed to amplify and extend immunity to this protein, which could allow for extended drug free periods and may delay disease progression.
Dr. Barry Peters, Head of the Academic Unit of HIV & STDs at the Guys & St Thomas' site of Kings College London, is leading the research in the UK and has 20 years of clinical experience of managing people with HIV infection. He says: "A successful immunotherapeutic HIV vaccine would give patients and doctors enormous advantages over current treatments, both in developed and developing countries. Even if this vaccine is not the final answer, it could help the march towards a successful immunotherapeutic HIV vaccine."
Dr. Richard Pollard, Head of the Infectious Diseases Division at The University of California, Davis Medical School, Sacramento, California, says "this is the largest current therapeutic vaccine trial in the world involving 345 patients. This trial will establish a solid foundation for HIV immune therapies if we can maintain immunogenicity during drug free periods.
About Vacc-4x Peptide Therapeutic Candidate