Oslo 10.09.2013 – Bionor Pharma ASA (OSE: BIONOR) announces that the Company has chosen romidepsin for the planned combination study with Vacc-4x, after considering various HDAC inhibitors (HDACi). Romidepsin is marketed in the US as Istodax® by Celgene Corporation Inc.
The “Kick, Kill” study is planned to be conducted by the HIV research team at Aarhus University Hospital, led by Prof. Lars Østergaard. Prof. Østergaard presented the background and expectations of the study at Bionor Pharma’s Capital Markets Day in June.
“HDAC inhibitors have recently shown the ability to release HIV from the lymphatic system where the virus hides, and positive data from this new HDAC inhibitor research will be published shortly” says Prof. Østergaard. He continues; “The combination of providing Bionor Pharma’s T-cell killing vaccine Vacc-4x, followed by an HDAC inhibitor may represent a new treatment that can completely or periodically enable patients to forego continuous treatment with HIV medications, and thereby lead to a Functional Cure. Romidepsin is chosen because it has proven to be the most effective HDAC inhibitor to release HIV from virus reservoirs where virus is hiding. We are very positive about this study which represents a new way to treat HIV, and have expectations that this can improve the current treatment of HIV”.
“Bionor Pharma is excited about the cooperation with the HIV scientists at Aarhus University Hospital, who are in the forefront within this novel field of HIV research” says Dr. Anker Lundemose, CEO Bionor Pharma. “Vacc-4x has previously demonstrated its ability to induce killing of virus producing cells by training the immune system, which seems to be essential as soon as an HDAC inhibitor has activated such cells from being dormant in the reservoir”.
Bionor Pharma will be the sponsor for the combination study at Aarhus University Hospital, and the plan is to submit the application with study protocol to the Danish Health Authorities by Q4 2013. Bionor Pharma filed patents on the combination of its vaccines with other treatment modalities including IMiD and HDACi earlier this year. The original romidepsin patent has expired.
The execution of the new “Kick Kill & Boost” strategy depends on funding of the Vacc-4x & HDACi combination trial. To this end, the Company continues to . evaluate various strategic and financial opportunities, and will continue to update the market on these efforts during H2 2013.
Bionor Pharma ASA
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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.
The Company has focused its research in therapeutic HIV vaccines, and has two vaccine candidates in the clinical stage of development: Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells, and Vacc-C5 is designed to induce antibodies to HIV that can reduce the harmful hyperactivation of the immune system which can lead to AIDS. The foremost candidate Vacc-4x is the furthest advanced T-cell vaccine in the HIV space and, has shown a statistically significant reduction in viral load in a phase II randomized, multinational, double-blind, placebo-controlled study.The Company’s innovative technology platform is also well positioned to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human papillomavirus) and CMV (Cytomegalovirus).
Bionor Pharma has twice been granted funds from GLOBVAC under administration of the Norwegian Research Council in 2012 and 2013.More information about Bionor Pharma is available at www.bionorpharma.com.
This information is subject to the disclosure requirements of §5-12 vphl (Norwegian Securities Trading Act). Vacc-4x, Vacc-C5, Vacc-HIV and Vacc-Flu are currently investigational treatments that have not been approved for marketing by any regulatory authority.