Bionor announces the assembly of a world-leading clinical study advisory board to discuss a first proof of principle Phase II clinical study for Vacc-4x as a component in the Functional Cure of HIV
(Oslo, Norway, 5 May) Bionor Pharma ASA (OSE:BIONOR), a leading biotechnology company searching for breakthrough products for the treatment and prevention of life-threatening viral diseases, today announces the assembly of a successful clinical study advisory board meeting with the participation of some of the world’s most prominent scientific advisors in HIV Cure research. The purpose of the meeting was to advise on the design of a proof of principle clinical study of Bionor’s therapeutic T-cell vaccine candidate Vacc-4x together with a latency reversing agent.
At the meeting it was decided to plan for a randomized, double-blind, placebo-controlled Phase II study. The aim is to investigate the contribution of Vacc-4x as a component in a Function Cure for HIV. The study will be conducted as an international trial that may include multiple sites in Europe, US and Australia. The study will be sponsored by Bionor Pharma and governed by a steering committee with experts contributing to the Clinical Study Advisory Board.
Bionor Pharma invited scientific advisors from the US, Australia and six European countries to discuss the best possible design of what will be the first proof-of-principle Phase II study combining a therapeutic vaccine and a latency reversing agent. Participants were as follows:
Brigitte Autran, Paris, France
Steven Deeks, San Francisco CA, USA
John Frater, Oxford, UK
Daniel Kuritzkes, Boston MA, USA
Sharon Lewin, Melbourne, Australia
Lars Ostergaard, Aarhus, Denmark
Guiseppe Pantaleo, Lausanne, Switzerland
Ole S Sogaard, Aarhus, Denmark
Martin Tholstrup, Aarhus, Denmark
Linos Vandekerckhove, Ghent, Belgium
Jan Van Lunzen, Hamburg, Germany.
Bionor’s President and Chief Executive Officer, Dr. David H. Solomon, commented: “The contribution of key advisors and the commitment to share knowledge and work together across continents is vital in order to work towards a Functional Cure for HIV. We are very grateful that these eminent experts in the field of HIV research were able to attend the meeting with Bionor and contribute their expertise. This gives us the best chance of ensuring that we put the best possible design in place for this important study. We look forward to continuing our close dialogue with regulatory agencies in Europe, the US and Australia over the coming months to prepare for the clinical trial application which we plan to submit later in 2015.”
“It’s great to be able to bring together such a distinguished panel of experts in the field of HIV research in order to plan
this important study,” said Prof. Lars Jørgen Østergaard, Aarhus University Hospital, Skejby, Denmark – Moderator of the meeting. “We are looking forward to sharing knowledge in order to plan for this important study.”
Bionor Pharma is a leading biotechnology company advancing the first therapeutic vaccine towards a functional cure for HIV. The company’s focus is the research and development of peptide-based vaccines against viral diseases, primarily HIV.
Bionor Pharma’s current clinical development pipeline comprises two vaccine candidates for the treatment of HIV, Vacc-4x and Vacc-C5. Vacc-4x is the most advanced therapeutic vaccine in the HIV space and has demonstrated a reduction of viral load in a large, randomized, controlled Phase II trial, as well as safety and tolerability. Bionor Pharma’s current clinical focus is to explore whether Vacc-4x, used with other medicines as a combination therapy, can reduce the viral load even further, and the company, through a collaboration with Celgene Corp, is investigating Vacc-4x and romidepsin in the REDUC study.
Bionor is listed on the Oslo stock exchange, under the ticker BIONOR.
More information about Bionor is available at www.bionorpharma.com.
For more information please contact:
Bionor Pharma ASA
President and Chief Executive Officer David Solomon: Tel +00 47 23 01 09 60
Consilium Strategic Communications
Mary-Jane Elliott / Ivar Milligan / Jessica Hodgson / Hendrik Thys
email@example.com+44 (0)20 3709 5700