NMA (SLV) approve testing of Vacc-4x using a nasal administration system

Oslo, 16.06.2011 - Oslo University Hospital has received approval to test Bionor Pharma's HIV-vaccine, Vacc-4x, using a nasal administration system

Oslo University Hospital has notified Bionor Pharma of approval from the Norwegian Medicines Agency (Statens Legemiddelverk) for an Investigator Initiated Study (IIS) to be conducted at Oslo University Hospital, testing the effect of Bionor Pharma's therapeutic HIV-vaccine candidate, Vacc-4x, on HIV-positive patients using a nasal administration system as delivery platform. The clinical study has funding from a grant from the Research Council of Norway. Approval by the Regional Ethics Committee is pending.

The study (EUDRACTNR 2011-000568-80) will be an investor initiated trial with Oslo University Hospital as sponsor and funder. The clinical costs will be covered by a grant from Norwegian Research Council (NRC) of NOK 6.9 mill. under the GLOBVAC programme. As product supplier, Bionor Pharma is obliged under an agreement to provide Vacc-4x vaccine, but has no other contractual obligations.

In Bionor Pharma's clinical trials so far, Vacc-4x has been administered using syringe injection beneath the skin surface (intradermal injection), and granulocyte macrophage colony stimulating factor (GM-CSF) has been the immune enhancing substance (adjuvant) used injected at the same site. In the planned study at Oslo University Hospital a nasal delivery platform will be tested, using a liposomal suspension developed by Eurocine AB as adjuvant.

"Effective administration is key to vaccine efficiency and a prerequisite for usage in developing countries. This clinical study initiated by Oslo University Hospital with support from the RCN is an opportunity to test alternative delivery platforms and alternative adjuvants," comments Henrik Lund, CEO of Bionor Pharma.

The clinical study will be designed as a single-blinded placebo-controlled clinical trial consisting of 24 HIV-patients stable on Anti-Retroviral Therapy (ART). Eighteen patients will be given Vacc-4x in combination with the adjuvant (three different dose groups), and the remaining six patients from the placebo group will receive Vacc-4x only. The study will be performed at Oslo University Hospital (Ullevål) with Professor Dag Kvale as Principal Investigator.

Investigator Initiated Study (IIS)

An Investigator Initiated Study (IIS) is a clinical study where the investigator or institution is solely responsible for funding, ownership of data, design of study protocol and maintaining the role as sponsor for the clinical study. The role of the Company is to provide the investigational substance and minimal practical support in the operational conduct of the study. The division of responsibilities between sponsors and investigators in Investigator Initiated Study (IIS) is regulated by the EU Clinical Trial Directive (Directive 2001/20/EC)