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Bionor Pharma Announces Successful Completion of the First Part of its Phase II Clinical Study Combining the HIV Vaccine Vacc-4x with Celgene’s Immunomodulator Lenalidomide (Revlimid®)

Oslo 13.06.2013 - The highest dose of lenalidomide has been chosen for the second, placebo-controlled part of the study, where a number of HIV patients are ready for screening

Bionor Pharma ASA (OSE: BIONOR) announced today that the first part of its phase II clinical study combining the HIV vaccine, Vacc-4x, with Celgene’s immunomodulator, lenalidomide, has been successfully completed. The aim of the first part of the study was to determine the highest tolerated dose amongst three different  lenalidomide doses. The results showed that all three doses were well tolerated, and the highest dose has been chosen for the second part of the study.  In this part the active group will receive Vacc-4x in combination with the chosen dose of lenalidomide, whereas the placebo group will only receive Vacc-4x. Four German clinics are conducting the trial, which will include HIV patients who have failed to regain a normal immune function (measured by CD4 T cell counts) despite having well controlled viral load from treatment with conventional HIV medication (antiretroviral therapy, cART).

HIV patients who fail to regain a normal immune function whilst on cART have increased morbidity and mortality. Bionor Pharma’s hypothesis is that Vacc-4x in combination with lenalidomide will induce cell-mediated immune responses leading to a recovery in immune cell counts as well as a decrease in viral load. In this way, Vacc-4x plus lenalidomide could have a significant impact on the treatment of HIV in patients on cART.

The objectives of the placebo-controlled study are to evaluate the changes in immune response in the two different Vacc-4x treated patient groups (with and without lenalidomide), measured by numbers and quality of the immune cells (CD4 and CD8). Although the patients have well controlled viral load from cART treatment, a secondary endpoint of the study is to evaluate the effect on HIV viral load by sensitive analysis methods.  Data from the study is expected in H1 2014.

About the study
The study takes place at four clinics in Germany. The patients, who have CD4 counts between 250 cells/mm3 and 500 cells/mm3, are on cART and will remain on this medication throughout the study period. The first part included 12 patents, and aimed to determine the highest tolerated dose out of three doses of lenalidomide in combination with Vacc-4x. The second, placebo-controlled, double-blinded part of the study is ready to start patient enrollment, and a number of patients are ready for screening. In total 24 patients will be included in this part. Half of the patients will receive Vacc-4x in combination with the selected dose of lenalidomide while the other half will receive Vacc-4x alone. The study period for the second part is 26 weeks. Bionor Pharma is the study sponsor and the costs are shared between Bionor Pharma and Celgene Corporation.

About Vacc-4x
Vacc-4x is a peptide-based HIV therapeutic vaccine, and is Bionor Pharma’s lead clinical candidate. Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells. Vacc-4x has been sucessfully tested in several Phase II studies, including a randomised, multinational double-blinded, placebo-controlled Phase IIb study in 135 patients where it exhibited a statistically significant 64% reduction in viral load compared to placebo.

About Lenalidomide (Revlimid®)
Lenalidomide is currently marketed by Celgene Corporation (NASDAQ: CELG), and has been used to successfully treat both inflammatory disorders and cancers for more than 10 years.  Lenalidomide is approved in more than 50 countries for the treatment of patients with blood cancer and patients with anemia. Lenalidonide is one of the best selling cancer medicines with annual sales of approx. US$ 3 billion. Lenalidomide has been shown to have immune modulating properties and influences the immune system in various ways that may enhance the immune stimulating effect of Bionor Pharma’s vaccines.

Bionor Pharma ASA
Hilde Aalling Syvertsen,
-Director Communications & Corporate Affairs 
Tel +47 23 01 09 60

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.

Global leader in the development of HIV vaccines
The Company has a leading position in the global research field for 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, 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).

Four vaccine candidates in development
HIV vaccine, Vacc-4x: 1. Clinical phase II study, combining Vacc-4x with Celgene’s immunomodulator lenalidomide (Revlimid®), to investigate whether lenalidomide enhances the effect of Vacc-4x in this placebo-controlled study in HIV patients with an impaired immune system.
2. Clinical phase II study, with Reboost in patients from the previous phase II study, aimed at reducing viral load even further.

HIV vaccine, Vacc-C5: Clinical phase I/II study, to investigate safety and whether the vaccine induces antibodies against HIV in humans.

HIV vaccine, Vacc-HIV (combination of Vacc-4x and Vacc-C5): A preclinical study is in preparation. The rationale behind Vacc-HIV is that this combination should prove more efficacious than each vaccine individually.

Universal influenza vaccine, Vacc-Flu: This vaccine is in the preclinical phase of development. Vacc-Flu is designed to produce long lasting immunity, and to be effective against all seasonal variations of influenza A.

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, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are currently investigational treatments that have not been approved for marketing by any regulatory authority.