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.
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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
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