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Bionor Pharma ASA Release: Final Regulatory Approvals Received for International Study to Reboost Patients From the Completed Vacc-4x Phase II Trial


12/5/2012 9:37:03 AM

OSLO, NORWAY--(Marketwire - December 05, 2012) - Bionor Pharma ASA (OSLO: BIONOR)

News Summary

  • Study design: Open, clinical phase II study, with two Vacc-4x immunizations while patients remain on conventional HIV medication (Antiretroviral Therapy, ART), followed by up to 16 weeks of treatment interruption

  • Primary endpoints: Changes in viral load compared to the previous study, and immune responses to the vaccine

  • Aim of the study: To determine whether a lower viral load level ("set point") can be achieved by reboosting previously Vacc-4x vaccinated HIV infected patients, indicating a potential for "stair stepping" down viral load through "booster" injections

  • Funding from GLOBVAC: Bionor Pharma was awarded NOK 10.48M/US$1.85M from Globvac in July 2012, primarily to fund the reboost study

Bionor Pharma ASA (OSLO: BIONOR) announced today that the new reboost study of patients from the previously conducted large phase II study with Vacc-4x, has been approved by all necessary regulatory authorities and will begin immediately at 11 clinics in USA, Germany, England, Spain and Italy.

The study is being conducted to investigate whether further reduction in viral load can be obtained in patients who participated in the previous Vacc-4x phase II study. Bionor Pharma was awarded NOK 10.48 million / US$ 1.85 million from Globvac (Research Council of Norway's program for Global Health- and Vaccine Research) in July 2012 towards funding for this study. Researchers hope the study will lead to a better understanding of how Vacc-4x can contribute to a "functional cure" for HIV, where the patients' immune system, with the help of the vaccine, becomes capable of keeping the virus under control.

About the Vacc-4x phase II reboost study
Up to 40 patients at 11 clinics, all from the previous phase II study with Vacc-4x, will take part in this reboost study. Patients will be given two booster immunizations with Vacc-4x while on ART. After an additional 8 weeks on ART, patients stop ART treatment for up to 16 weeks. The whole study period is approximately 37 weeks for each patient.

Results from the previous Vacc-4x phase II study
The virological data showed statistically significant 64% reduction of viral load "set point" (average of the last two viral load measurements before restarting ART) in patients receiving Vacc-4x compared to those given placebo. Moreover, the HIV viral load set point in patients given Vacc-4x was 60% lower than pre-ART (level before starting conventional HIV therapy, ART). In the placebo group, no change compared to pre-ART was observed.

Step towards long lasting HIV viral control with repeated Vacc-4x immunizations
ART is not a cure, but blocks virus production only while patients take this medication. ART must therefore be a lifelong treatment. Bionor Pharma's therapeutic vaccine Vacc-4x aims to induce long lasting virus control, either in combination with ART or without it, by training immune cells to seek out and kill virus-producing cells. The observed 64% reduction in viral load set point in patients who received Vacc-4x compared to placebo in the phase II study therefore represents a potential step towards "functional cure" for HIV.

In clinical practice, periods of ART interruption for various reasons or non-adherence are not uncommon.
In these situations, therapeutic vaccination to strengthen the immune system's ability to control the viral infection could provide an important health benefit.

Global HIV challenge
According to global authorities, 34 million people were living with HIV in 2011. There are approximately 2.7 million new HIV infected annually. 1.7 million people died from AIDS in 2011, and since the beginning of the epidemic, more than 60 million people have contracted HIV and nearly 30 million have died of HIV-related causes.

Only one out of four HIV-infected patients currently has access to ART treatment. According to recent CDC studies, less than 25 percent of people prescribed conventional HIV medicine stay permanently on the treatment. Pharmaceutical sales to treat HIV are approximately US$ 10.6 billion (NOK 63 billion) annually, and treatment cost per patient is approx. US$ 15,000 (NOK 90,000) per year.

About Bionor Pharma ASA
Bionor Pharma is a leading vaccine company, listed on the Oslo Stock Exchange. The Company's investments in developing therapeutic vaccines exceed US$70 million. Following closure of a private placement in June 2012, with gross proceeds of US$9.6 million, the Company has secured funding of planned scientific and business related activities until mid 2014.

Bionor Pharma's vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides, and they are designed to safely stimulate the immune system to combat viral diseases.

HIV vaccines, Bionor Pharma's leading projects
In addition to the previously mentioned research into Vacc-4x, Bionor Pharma has developed a second HIV vaccine candidate, Vacc-C5, to induce HIV antibodies that can reduce the harmful hyperactivation of the immune system, caused by HIV infection, which leads to AIDS.

Bionor Pharma is in the process of conducting three further studies that can lead towards phase III:

1. Vacc-4x in combination with Celgene's immune modulator Revlimid® (Lenalidomide), in patients who fail to regain a normal immune system despite having a well-controlled viral load on ART. The researchers will investigate whether Revlimid can enhance the effect of Vacc-4x. The placebo- controlled study was approved by German regulatory authorities to begin at four clinics in Germany in Q3 2012, and is currently recruiting patients.

2. Reboost with Vacc-4x in patients from the previous phase II study (USA and 4 European countries), to investigate whether this can result in a further reduction in viral load.

3. Clinical phase I/II study with Vacc-C5, to investigate safety, and whether this vaccine leads to the formation of antibodies against HIV in humans. The open study has been approved by the Norwegian regulatory authorities to begin at Oslo University Hospital, and is currently recruiting patients.

First results from the above studies are expected in 2013.

Bionor Pharma is exploring the possibility to combine Vacc-4x and Vacc-C5 (Vacc-HIV), as the basis for both a therapeutic and a preventive HIV vaccine.

Vaccines for other viral diseases
The Company's innovative technology platform is also well suited to develop vaccines for other viral diseases, including Influenza, HCV (Hepatitis C), CMV (Cytomegalovirus) and HPV (Human papillomavirus). The universal influenza vaccine (Vacc-Flu) and Hepatitis C vaccine (Vacc-HCV) are in the preclinical phase of development.

Business Strategy
Based on the three new studies with Bionor Pharma's HIV vaccines, and the preclinical data from studies with the universal influenza- and Hepatitis C vaccines, the Company has started a structured process for commercialization of the vaccine technology and products.

More information about Bionor Pharma is available at www.bionorpharma.com.

This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act). Vacc-4x, Vacc-C5, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are investigational treatments that have not been approved for marketing by any regulatory authority.


Contact information
Bionor Pharma ASA, Oslo
Hilde Aalling Syvertsen
Director Communications & Corporate Affairs
+47 23 01 09 60


USA Contact:
David Sheon
+1 202 422-6999
dsheon@WHITECOATstrategies.com

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