Eurocine Vaccines AB, Bionor Pharma ASA, and Oslo University Hospital announced that the nasal immunization study combining Bionor Pharma’s Vacc-4x and Eurocine Vaccines’ adjuvant Endocine is fully enrolled. Vacc-4x is a therapeutic HIV-vaccine based on four synthetic slightly modified peptide sequences from conserved parts of the P24 capsid protein of the HIV-virus. Endocine is an adjuvant that enhances immune responses to nasally administered vaccine antigens.
The clinical study is a single-blinded placebo-controlled clinical trial consisting of 24 HIV-patients stable on anti-retroviral therapy (ART). Eighteen patients will be given Endocine in combination with the Vacc-4x in three different dose groups, while the remaining six patients from the placebo group will receive Endocine only. All patients will remain on ART throughout the study. The study is expected to be completed 1Q 2012.
Bionor Pharma’s Vacc-4x has already shown in a placebo-controlled Phase IIb study to statistically significant reduce viral load in patients when delivered by injection. Researchers from Oslo University Hospital seek to study if nasal administration with Eurocine Vaccines´ Endocine will further boost responses to help patients better manage HIV through more accessible and efficient delivery. The research is funded by The Research Council of Norway (RCN)’s GLOBVAC program.
“We are pleased to report that patients have been generally very supportive to participate in this study” said Professor Dag Kvale, MD, Ph.D., Principal Investigator at Oslo University Hospital. “We are hopeful that nasal immunization could make a potentially new class of HIV treatment even easier to administer.”
“Successful results from this study could have favorable implications for delivery options for other Bionor vaccine candidates, as Influenza A and Hepatitis C,” said Steen Krøyer, CEO, Bionor Pharma ASA.
“We chose to study the combination of Vacc-4x and Endocine because of its potential to help the growing number of HIV patients who have unmet medical needs,” said Hans Arwidsson, CEO, Eurocine Vaccines AB. “When good business decisions are also good for global health, everyone wins.”
Date: January 4, 2012
Source: Eurocine Vaccines AB
