Du är här

2016-02-23

Bionor Pharma ASA: The final assay in Bionor's REDUC trial for measuring latent HIV reservoir, Integrated HIV DNA, supports the Shock & Kill approach using Vac

BIONOR PHARMA ASA

STOCK EXCHANGE ANNOUNCEMENT

The final assay in Bionor's REDUC trial for measuring latent HIV reservoir,
Integrated HIV DNA, supports the Shock&Kill approach using Vacc-4x and
romidepsin

REDUC Part B results were presented today at the prestigious Conference on
Retroviruses and Opportunistic Infections (CROI)

(Oslo, Norway, 23 February 2016) Bionor Pharma ASA (OSE:BIONOR), a
biopharmaceutical company focused on advancing a functional cure for HIV,
announces that the third and final assay for measuring latent HIV reservoir
size, the primary endpoint in the REDUC Part B trial, supports that the
combination of Vacc-4x and the latency reversing agent romidepsin (Istodax®,
Celgene) leads to a reduction in latent viral reservoir.

The REDUC Part B results were presented today at an oral presentation at the
prestigious Conference on Retroviruses and Opportunistic Infections (CROI),
in Boston, MA (USA). The presentation, entitled "Effect of Sequential
Vacc-4x/GM-CSF Immunization and Romidepsin on the HIV Reservoir", which began
at 10:15 am EST (16:15 CET), was delivered by Dr. Ole Schmeltz Søgaard from
Aarhus University Hospital in Denmark.

In REDUC Part B, three different assays were selected to measure the effect on
latent reservoir size due to ongoing discussions in the scientific HIV
community on how best to estimate the true size of the reservoir and the
effects of treatments. As reported on 21 December 2015, the first two assays
demonstrated a significant reduction in the latent HIV reservoir (by 40% in
Total HIV DNA and qVOA assays).

Today Bionor reports results from the third assay of latent HIV reservoir by
measuring levels of integrated HIV DNA. With the results of this assay
showing a mean 13% non-statistically significant (p=0.271) reduction, the
direction of all three assays is consistent. The technological differences
between these assays in view of sample sizes allows no further comparison of
absolute numbers.

Dr. David Horn Solomon, President and CEO commented:

"I am satisfied with the results announced today, which continue to validate
that the combination of Vacc-4x and romidepsin is an important element in the
development of a possible functional cure for HIV. The first announcement of
final results from the REDUC trial in December 2015 fostered world-wide and
substantial interest in Bionor from patients, opinion leaders and media, and
with the findings presented today, we are further encouraged to continue our
pioneering work. Also, I am proud that the REDUC results were accepted for
oral presentation at CROI, which, in my view, supports that we have obtained
important new scientific knowledge."

The completion of the REDUC trial constitutes a strong foundation for further
advancement of Vacc-4x as a core component in a functional cure for HIV. As
previously communicated, Bionor expects to initiate the international and
controlled BIOSKILL clinical trial when funding has been secured to execute
and complete the full scope of the trial. To date, Bionor has received
approval of its clinical trial applications for BIOSKILL in the United
Kingdom and Denmark.

Please refer to the stock exchange announcement from 21 December 2015 for
further information about the REDUC trial and Bionor's development plans.

This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.

Further information

David Horn Solomon, President and CEO, +45 22 20 63 00, dhs@bionorpharma.com
Jørgen Fischer Ravn, VP Investor Relations&Communications, +45 20 30 39 03,
jfr@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 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 also has
offices in Copenhagen, Denmark and New York, USA. Bionor is listed on Oslo
Børs (OSE:BIONOR). More information about Bionor is available
atwww.bionorpharma.com.

Bionor_CROI_Int HIV DNA Assay
http://hugin.info/131219/R/1988689/730217.pdf

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Bionor Pharma ASA via Globenewswire

HUG#1988689

Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.