Bionor Pharma Announces Approval of REDUC Trial

Bionor Pharma ASA announces that the Company has received approval from the Danish Regulatory Agency for its REDUC trial.

The REDUC trial is a combination of Bionor Pharma’s lead vaccine candidate Vacc-4x and the Histone DeAcetlyase inhibitor (HDACi) Istodax®(romidepsin). Bionor Pharma further announces that the Company today has entered into a Supply Agreement with Celgene Corp (NASDAQ: CELG). for supply of Istodax® for the REDUC trial. This agreement secures Bionor Pharma free supply of study drug of Istodax®.

The REDUC (“Kick and Kill”) trial’s objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate (“Kick”) these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate (“Kill”) the infected cells.

“We and others have shown that HIV can be kicked into activation by use of HDAC inhibitors” said Professor Lars Østergård, Aarhus University Hospital. “The next natural step towards a cure against HIV is to combine such kick strategy with a kill-strategy. The Vacc-4x vaccine is one of the most advanced kill strategies and combining an HDACi with Vacc-4x represent the obvious choice. The results obtained from the REDUC study are likely to be of major scientific impact in the hunt for a cure for HIV.”

About the REDUC trial
The REDUC trial will study the combination of the HDAC inhibitor Istodax®and Vacc-4x in HIV patients on combination antiretroviral therapy (cART).  The first phase of the study will establish the optimal dose of Istodax® based on safety and the effect on the latent reservoir. The second phase will include vaccination with Vacc-4x followed by treatment with Istodax® once a week for three weeks. Patients will then have a protocol specified cART treatment interruption for 18 weeks.   During this period without cART the control of HIV replication will be evaluated to see if the virus load continues to be suppressed by the immune system. Bionor Pharma is the study sponsor and Department of Infectious Diseases Q, Aarhus University Hospital, Denmark with Lead investigator Professor Lars Østergaard will be conducting the study. Enrollment of patients into the study is planned  for Q2 2014.

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