The peer-reviewed and highly recognized journal The Lancet HIV has accepted the results of the REDUC Part B trial for publication
(Thomson Reuters ONE) -
BIONOR PHARMA ASA
STOCK EXCHANGE ANNOUNCEMENT
The peer-reviewed and highly recognized journal The Lancet HIV has accepted the
results of the REDUC Part B trial for publication
(Oslo, Norway, 9 June 2016) Bionor Pharma ASA (Bionor) (OSE:BIONOR), announced
today that the positive results from the clinical trial REDUC Part B (BPC01-
001) will be published for the first time in the peer-reviewed and highly
recognized journal The Lancet HIV. The manuscript, entitled "The combined effect
of Vacc-4x/rhuGM-CSF vaccination and romidepsin on the HIV-1 reservoir: a phase
Ib/IIa, single group, clinical trial", will be published online shortly. Ole
Schmeltz Søgaard from Aarhus University Hospital in Denmark is corresponding
author of the manuscript. Top line results from REDUC Part B were announced by
Bionor on 21 December 2015.
The REDUC Part B trial resulted in important signals, which provide the first
evidence for the feasibility of a Shock & Kill strategy for achieving a
functional cure for HIV infection:
* Latent HIV reservoir was significantly reduced by approximately 40% measured
by Total HIV DNA and qVOA. Measured by Integrated HIV DNA, a statistical
non-significant decrease of 19% was observed.
* Viral load (Plasma HIV-1 RNA) remained below the limit of detection (20
copies/ml) in 11 of 17 patients throughout the trial while on cART despite a
documented viral reactivation in CD4+ T cells following romidepsin
infusions. Of the six patients with detectable viral load, four patients had
measureable but low HIV in the blood after one of the three romidepsin
infusions. Importantly, only two of 17 patients had detectable viral load
after each of the three romidepsin infusions.
* The treatment of Vacc-4x/rhuGM-CSF and romidepsin (Istodax(®), supplied by
Celgene Corporation) was safe and well tolerated. All adverse reactions were
consistent with the known side effects of either romidepsin or Vacc-
4x/rhuGM-CSF.
These results are crucial in showing that Vacc-4x administered with rhuGM-CSF is
capable of priming the immune system to control HIV in the blood after the virus
has been 'shocked' out of its dormant state by a latency reversing agent. The
trial results are supported by previous data, demonstrating that Vacc-4x/rhuGM-
CSF reduced the viral load set-point during antiretroviral treatment
interruption in a placebo-controlled trial (CT BI-Vacc-4x 2007/1).
Unni Hjelmaas, Acting CEO, commented: "The publication of the REDUC Part B
results in The Lancet HIV underpins our view that Bionor is advancing a first-
in-class functional cure for HIV. Having peer reviewers support that trial
results are very encouraging and provide the first evidence that the concept of
Shock & Kill may work is reassuring for our ongoing efforts to secure the future
financing of the company and position our therapeutic vaccine Vacc-4x as a core
component in HIV immunotherapy."
The results also emphasize that further optimization of the Shock & Kill
strategy is needed to achieve a sizeable impact on the latent reservoir that
will translate into clinically measureable benefits for persons living with HIV,
as the combined intervention did not prolong median time to viral rebound during
ART interruption. Bionor anticipates that a third agent capable of further
strengthening immune reactivity is needed as part of a combination treatment in
addition to Vacc-4x and a latency reversing agent. These considerations have
previously been described in the company's announced clinical strategy and are
being addressed in the BIONAB clinical trial.
Based on the REDUC data, Bionor is currently also planning BIOSKILL, a
multicenter placebo-controlled proof of concept Phase II clinical trial, which
is intended to document the potential of Vacc-4x as a core component of a HIV
cure strategy.
Further information
Unni Hjelmaas, Acting CEO, +47 915 19 651, uh(at)bionorpharma.com
Jørgen Fischer Ravn, VP Investor Relations & Communications, +45 2030 3903,
jfr(at)bionorpharma.com
About Bionor
Bionor Pharma is a Norwegian biopharmaceutical company focused on advancing its
proprietary therapeutic vaccine Vacc-4x in combination with other medicines
toward a functional HIV cure. The company believes it has first mover potential
based on clinical results to date and early adoption of now recognized clinical
strategy. In December 2015, Bionor announced that the HIV 'Shock & Kill' trial
REDUC with Vacc-4x and romidepsin successfully met its primary endpoint by
significantly reducing latent HIV reservoir and further demonstrated control of
viral load. Bionor is currently planning BIOSKILL, a proof-of-concept Phase II
trial, which may lead to a major value inflection point and partnering
opportunities. Bionor currently retains full ownership rights to Vacc-4x, i.e.,
the upside potential from partnering or licensing remains with the company.
Bionor is based in Oslo, Norway and is listed on Oslo Børs (OSE:BIONOR). More
information about Bionor is available at www.bionorpharma.com.
Bionor_Lancet_June2016:
http://hugin.info/131219/R/2019334/749657.pdf
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originality of the information contained therein.
Source: Bionor Pharma ASA via GlobeNewswire
[HUG#2019334]
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Datum: 09.06.2016 - 14:52 Uhr
Sprache: Deutsch
News-ID 476799
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