Date: 2012-05-10
Type of information:
phase: 2b
Announcement: results
Company: Bionor Pharma (Norway) Eurocine Vaccines (Sweden)
Product: Vacc-4x and Endocine
Action mechanism: Vacc-4x is a therapeutic HIV-vaccine based on four, slightly modified peptides (building blocks of proteins) from conserved parts of the HIV-virus. Endocine is an adjuvant shown to enhance the immune response to vaccine antigens delivered nasally.
Disease: HIV-Aids
Therapeutic area: Infectious diseases
Country:
Trial
details: The single blinded, randomized, placebo-controlled, immunogenicity study included 24 patients, all receiving conventional HIV medicine (antiretroviral therapy, ART). 18 patients received active, nasal vaccine (both Vacc-4x and the adjuvant Endocine) at either of three different dose levels of Vacc-4x, and 6 patients received Endocine only (control group). All patients were given weekly nasal drops for four weeks (one patient was withdrawn at week 6, without reasons related to the study). The final study visit was scheduled at week 8.
Latest
news: * On May 10, 2012, Bionor Pharma ASA, Eurocine Vaccines AB and Oslo University Hospital have announced that vaccine related immune responses are documented in patients given active vaccine in a nasal immunization study, combining Bionor Pharma's Vacc-4x and Eurocine Vaccines' adjuvant Endocine. The results are furthermore documenting safety by nasal administration of the vaccine. Researchers at Oslo University Hospital studied the effect of nasal delivery of Vacc-4x in combination with Eurocine Vaccines' adjuvant Endocine, compared to the effect of Endocine alone. Overall,the treatment was very well tolerated, although some reported mild and transient sensations in the nose the same day. Only the patients given active nasal vaccine (with Vacc-4x) increased their vaccine related immune responses during the 8 weeks study period. This outcome was further confirmed by a skin test (DTH). Bionor`s second HIV therapeutic vaccine, Vacc-C5 is planned to be ready for first in man clinical trial 2Q 2012, and is developed to induce antibodies to HIV that can reduce immune hyper activation associated with HIV infection. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventative vaccine. The clinical costs have been covered by a grant from The Research Council of Norway (RCN) of US$ 1.2 million (NOK 6.9 million), under the GLOBVAC program.
These results support that immunization of HIV-infected individuals by nasal co- administration of Vacc-4x and Endocine adjuvant is safe and is able to strengthen vaccine related immune responses. Dose-related differences are currently under evaluation, and additional data including antibody production in mucosal secretions will be analyzed and published at a later stage.
Bionor researchers believe that the 64 % reduction in viral load in patients who received Vacc-4x in the phase IIb study is a long-lasting viral control as aresult of the patient's immune system`s new ability to kill virus producingcells, in contrast to the viral reduction obtained with daily conventionalmedicine (antiretroviral therapy, ART). Research shows that treatment with ART is putting the virus producing cells into a resting state, from which they can \"wake up\" even more than a decade later, and again start producing virus withinfew weeks if patients go off ART. Because most patients who are given ART are known to stop taking it for various reasons (high costs, limited access,development of resistance, and serious adverse events), Bionor believes Vacc-4xcould be a vital treatment option that can stabilize patients even when they stop taking ART.
