Norway-based Bionor Pharma (OSE: BIONOR) saw its shares leap 16% to 3.67 kroner on June 13, after the company revealed that the first part of its phase II clinical study combining the HIV vaccine, Vacc-4x, with Celgene’s immunomodulator, Revlimid (lenalidomide), has been successfully completed.
The aim of the first part of the study was to determine the highest tolerated dose among three different lenalidomide doses. The results showed that all three doses were well tolerated, and the highest dose has been chosen for the second part of the study. In this part the active group will receive Vacc-4x in combination with the chosen dose of lenalidomide, whereas the placebo group will only get Vacc-4x. Four German clinics are conducting the trial, which will include HIV patients who have failed to regain a normal immune function (measured by CD4 T cell counts) despite having well controlled viral load from treatment with conventional HIV medication (antiretroviral therapy, cART).
HIV patients who fail to regain a normal immune function whilst on cART have increased morbidity and mortality. Bionor Pharma’s hypothesis is that Vacc-4x in combination with lenalidomide will induce cell-mediated immune responses leading to a recovery in immune cell counts as well as a decrease in viral load. In this way, Vacc-4x plus lenalidomide could have a significant impact on the treatment of HIV in patients on cART.
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