Oslo 29.04.2013 – Bionor Pharma ASA (OSE: BIONOR) announced today that all patients are now enrolled in the study for reboost of patients from the previously conducted phase II clinical study with Vacc-4x.
Thirty-three Patients Participate at 10 Clinics in USA and Europe
The 33 patients are recruited at 10 clinics in USA, Germany, England, Spain and Italy. The previous Vacc-4x phase II study showed a statistically significant 64% reduction in viral load, and this study is being conducted to investigate whether a further stepwise reduction in viral load can be achieved by reboosting patients who participated in the previous Vacc-4x 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, which will enable people to live long-term with no active HIV replication or disease progression in the absence of ongoing conventional HIV medication (antiretroviral therapy, ART).
About the Vacc-4x phase II reboost study
Study design: Open, clinical phase II study, with two Vacc-4x immunizations while patients remain on ART, followed by up to 16 weeks of treatment interruption. Thirty-three patients at 10 clinics, all from the previous phase II study with Vacc-4x, will take part in this reboost study. Patients are given two booster immunizations with Vacc-4x while on ART. After an additional 8 weeks on ART, patients stop taking ART for up to 16 weeks. The whole study period is approximately 37 weeks for each patient, which means that all patients are expected to have completed the study by January 2014. Analyzed data from the study will be announced 1H 2014.
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” (average of the last two viral load measurements before restarting ART) can be achieved by reboosting previously Vacc-4x vaccinated HIV infected patients, indicating a potential for “stair stepping” down viral load through “booster” injections.
Results from the previous Vacc-4x phase II study
The virological data from this study showed a statistically significant 64% reduction of viral load “set point” 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 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 for HIV, it only blocks virus production 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 people newly infected with HIV annually. Approximately 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 Centers for Disease Control and Prevention (CDC) studies, less than 25 percent of people prescribed conventional HIV medication stay permanently on the treatment. Global annual pharmaceutical sales to treat HIV are approximately US$ 10.6 billion (NOK 63 billion), and the treatment cost per patient is approximately US$ 15,000 (NOK 90,000) per year.
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 immune modulator Revlimid® (Lenalidomide), to investigate whether Revlimid 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.