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Bionor Pharma ASA : Results for viral load on Vacc-4x

02/15/2012 | 06:44am US/Eastern

Oslo 15.02.2012 - With final review of phase IIb viral load data completed, researchers confirm statistically significant reduction of HIV viral load on Vacc-4x compared to placebo

 Bionor`s Clinical Research Program Moves Forward with Three Main Pathways to Market

News Summary
• Final review of phase IIb data confirms statistically significant 64% reduction of viral load "set point" (average of the last two viral load measurements before the end of the study) in patients receiving Vacc-4x compared to those given placebo, indicating a possible new option for patients and doctors.
• The HIV viral load set point in patients given Vacc-4x was 60% lower than pre-ART (level before starting with standard medicine, ART).  In the placebo group, no change compared to pre-ART was observed. 
• The conclusive data provide a basis for further HIV trials, offering Bionor three main pathways to market:
o Re-vaccination  to reduce the viral set point further - aiming at a 'functional cure'
o Immunization in the presence of Revlimid®,  targeting patients that fail to regain immune competence (CD4 counts) while on ART
o Combining Vacc-4x and Vacc-C5, which could potentially revolutionize HIV management

 Bionor Pharma announced today that researchers have completed a final review of the Company`s lead therapeutic HIV vaccine, Vacc-4x, and its ability to reduce the amount of HIV circulating in patients ("viral load").

These final conclusions from the phase IIb, placebo-controlled, double-blind, international, multicenter trial, confirm initial findings of a statistically significant difference in viral load set point between Vacc-4x and placebo groups at the end of the study. The full results in addition to the final review of the immunological assessment are being prepared for publication in an international peer reviewed journal.

Vacc-4x is designed to generate immune responses to conserved domains of p24 that are common to all strains of HIV. Sustained immune responses to p24 have previously been shown to delay HIV disease progression.

Researchers from the Ragon Institute, Harvard, and MIT published in 2011 findings confirming the existence of conserved regions on p24 and emphasizing their potential as targets for an HIV vaccine. Bionor identified these domains over a decade earlier, and began developing the vaccine based on these findings. Today Bionor's Vacc-4x is the most studied immunotherapeutic product targeting p24.

About Vacc-4x phase IIb study and results
136 patients participated in the five country trial, with two-thirds (93) randomized to receive Vacc-4x together with ART, while one-third (43) received a placebo injection and ART. Patients were immunized with Vacc-4x or placebo while on ART over a period of 28 weeks. This was followed by a period without treatment, lasting up to 24 weeks (until week 52).

For patients that successfully completed the study (week 52), the placebo group (n=25) had a viral load set point of 61,900 cmL compared to the Vacc-4x group (n=56) that had a viral load set point of 22,300 cmL. This difference represents a reduction of 64% and is statistically significant (p =0.04). All values represent median.

A subgroup comparison has been performed with only those patients who had a known viral load measurement before starting ART (pre-ART). The placebo group (n= 18) had no statistically significant difference between pre-ART viral load (52,731 cmL) and the viral load set point at the completion of the study (50,400 cmL, p= 0.98). In contrast, the Vacc-4x group (n=45) had pre-ART viral load of 60,470 cmL, compared to 24,150 cmL at study completion, resulting in a statistically significant reduction of 60% (p= 0.0001).

The previously reported findings showing an association between viral load and HIV-specific immune responses are also confirmed. Patients with immune responses to p24 at study termination had a higher viral load set point in the placebo group (61,900 cmL) compared to the Vacc-4x group (22,925 cmL). HIV-specific immune responses resulted in increased viral load in the placebo subjects, whereas the Vacc-4x group had a significantly better viral control (p=0.048).

"These final results confirm that Vacc-4x lowers viral load in patients with HIV who have remained off ART for at least 6 months," said Vidar Wendel-Hansen, MD, PhD, Chief Medical Officer, Bionor Pharma, "and suggests a correlation between this effect and the vaccine induced immune responses to p24." 

Several independent further paths to market for Vacc-4x
Based on the conclusive phase IIb data, Bionor is studying several paths to guide the direction towards a Phase III pivotal trial, the final study before regulatory review and market entry:

1. Vacc-4x revaccination of patients from the phase IIb study, to further reduce the viral load set point (study planned 1H 2012). Based on the statistically significant lowering of viral load after vaccination with Vacc-4x compared to before taking ART, Bionor researchers plan to re-vaccinate Vacc-4x patients from the IIB study to see if the viral set point can be reduced even further.  Such an approach may eventually form a "functional cure," meaning that HIV viral load is gradually reduced to lower levels following successive ART-free periods.

2. Vacc-4x in combination with Revlimid® (Lenalidomide), for patients with unmet medical needs (study planned 1 H 2012). Based on the confirmed ability for Vacc-4x to lower viral load in HIV patients, Bionor will study the effect of combining Vacc-4x with Revlimid, for patients who are well controlled on ART but fail to regain immune competence (CD4 T-cell counts). By combining Vacc-4x with Revlimid, an immunomodulatory drug, Bionor`s researchers will determine whether patients experience improvement.

3. Vacc-4x in combination with Vacc-C5, to reduce viral load and the spread of infection. Vacc-C5 is designed to induce antibodies to HIV that can reduce HIV associated immune hyperactivation which leads to AIDS. Preclinical studies have shown that Vacc-C5 successfully induced antibodies against HIV in animal models such as rabbits and sheep. Bionor intends to conduct the first clinical study of Vacc-C5 in man in 2Q 2012. 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 is furthermore investigating different options for administration of its vaccines.
An ongoing trial at Oslo University Hospital aims to reveal whether Vacc-4x given by nasal administration can provide equivalent effect compared to delivery by needle injection. Such administration will be important for cost and availability in both Western and especially developing countries. All patients have been successfully included in the trial and the results are expected in first half of 2012.

Partnering process
The successful outcome of the phase IIb clinical trial, together with the Company`s further preclinical and clinical program, makes a partnering process a natural next step for Bionor Pharma.

About Bionor Pharma ASA
Bionor Pharma is a biopharmaceutical, listed company based in Oslo, Norway.

The Company's lead investigational product, the HIV therapeutic vaccine Vacc-4x, has completed a phase IIb multinational, placebo controlled double-blind trial, which found a statistically significant reduction in viral load in treated subjects.

A second HIV therapeutic vaccine, Vacc-C5 is developed to induce antibodies to HIV that can reduce immune hyperactivation associated with HIV infection, which leads to AIDS. The first clinical trial for Vacc-C5 is planned 2Q 2012. Because researchers have already found that patients with antibodies to the C5 region on HIV have little virus in their blood and slow disease progression, Bionor anticipates that Vacc-C5 will offer an important weapon towards finding a functional cure for HIV. Vacc-4x in combination with Vacc-C5 can potentially revolutionize the management of HIV infection and could form the basis for a preventative HIV vaccine.

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) and HPV (Human Papilloma Virus).  Preclinical studies with Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) are planned to be finalized in second half 2012, preparing for the clinical stage of development and partnering.

Bionor's vaccines are based on the proprietary technology platform developed following several years of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral disease.

Bionor seeks to create positive cash flow at an early stage of development by signing partnering deals with biotechnology and pharmaceutical companies. This includes short-term out-licensing of products with royalty payments or direct funding of clinical trials, such as Bionor's agreement signed in August 2011 with one of the world's largest Biotech companies. The collaboration includes a clinical trial on patients/subjects with HIV using a combination of Vacc-4x, and the cancer drug Revlimid.

More information about Bionor Pharma, its research and products, 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 is an investigational treatment that has not been approved for marketing by any regulatory authority.

# # #


Contacts
Bionor Pharma ASA, Oslo: +47 23 01 09 60/ Skien: +47 35 90 85 00
Steen Krøyer, CEO,   or Vidar Wendel-Hansen, CMO, Chief Medical Officer

USA Contact: 
David Sheon +1 202 422-6999

dsheon@WHITECOATstrategies.com

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