HIV treatment with nasal-drop form

Oslo 10.04.2012 – Bionor Pharma ASA (OSE: BIONOR) today announces that the placebo controlled study of nasally administered HIV therapeutic vaccine Vacc-4x in combination with Eurocine Vaccines` Endocine has been finalized in Q1 as planned and previously communicated. 24 patients were included, and 23 completed the study. No serious adverse events have been reported.

Analysis of the comprehensive data has started, and first results from the study are planned to be released during first half of May 2012.

About Eurocine Vaccines
Eurocine Vaccines is a publicly listed, clinical-stage company developing nasal vaccines that meet important medical needs. The vaccines are developed up to proof of concept (clinical phase I/II) and licensed to partners for further development and commercialization. The company’s proprietary vaccine adjuvant technologies, which are a key element of the nasal vaccines, are also offered to license partners for development in various indications.

More information about Eurocine Vaccines, its research and products, is available at

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)

About Bionor Pharma ASA

Bionor Pharma is a biopharmaceutical, listed company based in Oslo, Norway. (OSE: BIONOR) The Company’s investments in developing therapeutic vaccines are more than US$60 million. Bionor’s vaccines are based on the proprietary technology platform developed following decades of research on peptides. The vaccines are designed to safely activate each person’s immune system to combat viral disease.

The Company’s lead investigational product, the HIV therapeutic vaccine Vacc-4x, has completed a phase IIb multinational (USA, Germany, UK, Spain and Italy), placebo controlled double-blind trial, which found a statistically significant reduction in viral load in treated subjects. The second HIV therapeutic vaccine, Vacc-C5 is expected to be ready for first in man clinical trial 2Q 2012, and is developed to induce antibodies to HIV that can reduce immune hyper activation associated with HIV infection. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, a treatment that can potentially revolutionize the management of HIV infections and could form the basis for both a therapeutic and a preventative vaccine.

Bionor researchers has been investigating three potential pathways to market for the HIV vaccine candidates Vacc-4x and Vacc-C5, through further clinical studies:

  1. Vacc-4x revaccination study with patients who participated on the phase IIb study, which aims to further reduce their viral load set point, during periods that the patients are not on traditional medicine (antiretroviral therapy (ART)).
  2. Vacc-4x combined with Revlimid® (lenalidomide), for patients with unmet medical needs today, no longer responding well to ART.
  3. Vacc-C5 clinical trial phase I/II, subsequent Vacc-C5 in combination with Vacc-4x.
  4. The Company’s innovative technology platform is also well suited to the development of vaccines for a wide range of other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human Papilloma Virus) and CMV (Cytomegalovirus). Preclinical studies with Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) are planned to be finalized in second half 2012.

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