Results from Nasal Administration Study of HIV Vaccine Vacc-4x and Endocine Expected First Half of May
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 www.eurocine-vaccines.com
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 will investigate three potential pathways to market for the HIV vaccine candidates Vacc-4x and Vacc-C5, through further clinical studies starting this year:
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.
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.
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com
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Bionor Pharma ASA, Oslo: +47 23 01 09 60/ Skien: +47 35 90 85 00
Steen Krøyer, CEO
Vidar Wendel-Hansen, CMO