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Bionor Pharma Announces Successful Completion of Part A of REDUC Study; First Evidence that Romidepsin “Kicks” HIV out of Reservoirs

•HDAC inhibitor (HDACi) Istodax® (romidepsin) successfully reactivated (“kick”) HIV in patients
•Treatment of Istodax® was safe and well tolerated
•Part B of the REDUC study to enroll patients in Q2 2014

(Oslo, Norway, 12 May 2014)  Bionor Pharma ASA (OSE: BIONOR) announces that the part A of the REDUC study has successfully completed. The objective of part A of the study was to establish the optimal dose of the HDACi Istodax® (romidepsin) based on safety and the effect on HIV reactivation. Treatment with 5mg/m2 of romidepsin was successfully able to reactivate HIV in 6 patients while on conventional HIV medication cART. Both cell-associated un-spliced HIV RNA as well as extracellular HIV RNA were significantly increased as a result of romidepsin infusion. The treatment was safe and most adverse events (AEs) were of grade 1. Two grade II AEs in one individual were observed. No serious adverse events were observed.

Data from part A of the study will be submitted to the upcoming international AIDS society (IAS) conference meeting.

The objective of part B of the REDUC trial is to investigate the effect on the HIV latent reservoir and viral load by combining Vacc-4x vaccination with romidepsin reactivation of HIV. Researchers refer to this approach as a “Kick-kill” strategy, where the HDACi is used to “kick” the virus out of reservoirs making the HIV infected cells visible to the immune system; the immune response generated by Vacc-4x will be able to attack and eliminate the infected cells. Conventional HIV medication, cART is shown not to be able to address the virus in reservoirs and sanctuary regions.

Enrollment of patients for part B is expected to start in Q2 2014.

"As predicted by pre-clinical work, it is comforting to know that romidepsin can reactivate latent HIV reservoirs in patients,” said Professor Lars Østergaard, Aarhus University Hospital, the Principal Investigator of this trial. “We are pleased with today’s results, and this looks very promising for the key objective of the trial exploring the potential reduction of the latent HIV reservoirs by Vacc-4x vaccination following by romidepsin activation,” continued Professor Lars Østergaard. “Especially the significant detection of HIV RNA in plasma by a standardized and routine RT-PCR assay indicates a strong ability of romidepsin to activate the reservoir.”

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 established the optimal dose of Istodax® based on safety and the effect on latent reservoirs. 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 viral load continues to be suppressed by the immune system. Bionor Pharma is the study sponsor. The Department of Infectious Diseases, 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.

About Bionor Pharma ASA
Bionor Pharma is a leading biotechnology company, searching for breakthrough products for the treatment and prevention of life-threatening viral diseases. The Company is listed on the Oslo Stock Exchange, and is developing vaccines for viral infections. The vaccines are based on a proprietary technology platform developed following more than two decades of research into peptides, and they are designed to safely stimulate the immune system to combat viral diseases. 

More information about Bionor Pharma is available at www.bionorpharma.com.

Bionor Pharma ASA
CFO Synne H Røine, Norway Tel +47 99 22 98 92 
David Sheon, USA  Tel  +1 202 422-6999