Successfully results from clinical study with Vacc-4x and Endocine
Oslo 10.05.2012 - Successful Immunization and Safety Documented in Nasal Administration Study of the HIV Vaccine Vacc-4x together with Endocine
This New Option May Offer Easier Treatment Access for HIV Patients Globally
* Vaccine related immune responses found in HIV patients given Vacc-4x
together with Endocine through nasal administration in a placebo controlled
* The study also documents safety by nasal administration
* Further analyses are ongoing, and will be published at a later stage
Bionor Pharma ASA, Eurocine Vaccines AB and Oslo University Hospital today announced that vaccine related immune responses are documented in patients given active vaccine in a nasal immunization study, combining Bionor Pharma's Vacc-4x and Eurocine Vaccines' adjuvant Endocine. The results are furthermore documenting safety by nasal administration of the vaccine.
The clinical costs have been covered by a grant from The Research Council of Norway (RCN) of US$ 1.2 million (NOK 6.9 million), under the GLOBVAC program.
Vacc-4x is a therapeutic HIV-vaccine based on four, slightly modified peptides (building blocks of proteins) from conserved parts of the HIV-virus. Endocine is an adjuvant shown to enhance the immune response to vaccine antigens delivered nasally.
Researchers at Oslo University Hospital studied the effect of nasal delivery of Vacc-4x in combination with Eurocine Vaccines' adjuvant Endocine, compared to the effect of Endocine alone.
"We are pleased to report positive, preliminary results from the study, indicating that Vacc-4x for HIV patients may be given by Nasal administration as well as by injection," said Professor Dag Kvale, MD, Ph.D., Principal Investigator at Oslo University Hospital. "These results are promising for HIV patients globally, by potentially providing a new class of HIV treatment that's even easier to deliver."
"We are seeing these data as important, both for the Vacc-4x and for our other vaccine candidates," said Steen Krøyer, CEO, Bionor Pharma ASA.
"Positive results from this study with nasally delivered combination of Vacc-4x and Endocine can pave the way to help the growing number of HIV patients with unmet medical needs," said Hans Arwidsson, CEO, Eurocine Vaccines AB.
About the Study and the Results
The single blinded, randomized, placebo-controlled, immunogenicity study included 24 patients, all receiving conventional HIV medicine (antiretroviral therapy, ART). 18 patients received active, nasal vaccine (both Vacc-4x and the adjuvant Endocine) at either of three different dose levels of Vacc-4x, and 6 patients received Endocine only (control group). All patients were given weekly nasal drops for four weeks (one patient was withdrawn at week 6, without reasons related to the study). The final study visit was scheduled at week 8. Overall, the treatment was very well tolerated, although some reported mild and transient sensations in the nose the same day.
Only the patients given active nasal vaccine (with Vacc-4x) increased their vaccine related immune responses during the 8 weeks study period. This outcome was further confirmed by a skin test (DTH).
These results support that immunization of HIV-infected individuals by nasal co- administration of Vacc-4x and Endocine adjuvant is safe and is able to strengthen vaccine related immune responses. Dose-related differences are currently under evaluation, and additional data including antibody production in mucosal secretions will be analyzed and published at a later stage.
About the HIV vaccine Vacc-4x
Vacc-4x is a therapeutic HIV-vaccine based on four, slightly modified peptide sequences from conserved (stable) parts of the HIV-virus, which doesn`t change even if the virus mutates (is changing). The chosen peptides have been modified to increase immunogenicity of the vaccine. The product has broad patent protection.
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. The Company's investments in developing therapeutic vaccines exceed US$70 million. Bionor's vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral diseases.
The Company's lead investigational product, the HIV therapeutic vaccine Vacc-4x, has in a completed phase IIb multinational (USA, Germany, UK, Spain and Italy), placebo controlled, double-blind study, shown a statistically significant reduction in viral load.
Bionor researchers believe that the 64 % reduction in viral load in patients who received Vacc-4x in the phase IIb study is a long-lasting viral control as a result of the patient's immune system`s new ability to kill virus producing cells, in contrast to the viral reduction obtained with daily conventional medicine (antiretroviral therapy, ART). Research shows that treatment with ART is putting the virus producing cells into a resting state, from which they can "wake up" even more than a decade later, and again start producing virus within
few weeks if patients go off ART. Because most patients who are given ART are known to stop taking it for various reasons (high costs, limited access, development of resistance, and serious adverse events), Bionor believes Vacc-4x could be a vital treatment option that can stabilize patients even when they stop taking ART.
Bionor`s second HIV therapeutic vaccine, Vacc-C5 is planned to be ready for first in man clinical trial 2Q 2012, and is developed to induce antibodies to HIV that can reduce immune hyper activation associated with HIV infection. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventative vaccine.
According to the UN organization UNAIDS, 34 million people were living with HIV in 2010. Approximately three million new people are infected annually. Pharmaceutical sales to treat HIV are US$ 10.6 billion (NOK 63 billion) annually, and treatment cost per patient is approx. US$ 15,000 (NOK 90,000) per year.
Only one out of six HIV infected patients globally are today provided with treatment.
Pathways to market for HIV vaccines
Bionor researchers will investigate various independent pathways to market for
the HIV vaccine candidates Vacc-4x and Vacc-C5, through further clinical studies
starting this year:
1. Vacc-4x revaccination in patients who participated in the phase IIb study,
which aims to further reduce the viral load by killing of virus producing cells,
during periods where patients are not on ART.
2. Vacc-4x combined with Revlimid® (lenalidomide), in patients with a weakened
immune system which does not improve despite well controlled viral load by
treatment with ART.
3. Vacc-C5 clinical trial phase I/II, to document whether Vacc-C5 increases HIV
antibodies, subsequent Vacc-C5 in combination with Vacc-4x, with the aim of
eradicating HIV and thereby revolutionize HIV treatment.
Vaccines for other viral diseases
The Company's innovative technology platform is also well suited to develop
vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV
(Human Papilloma Virus) and CMV (Cytomegalovirus).
All preclinical trials with Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV
(Hepatitis C vaccine), including toxicology are planned to be finalized second
half 2012, thereby being ready to enter human clinical studies.
More information about Bionor Pharma, its research and products, is available at
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act).
Vacc-4x is an investigational treatment that has not been approved for marketing
by any regulatory authority.
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Bionor Pharma ASA, Oslo: +47 23 01 09 60/ Bionor Pharma`s laboratories:
+47 35 90 85 00
Steen Krøyer, CEO
David Sheon 202 422-6999