Onxeo Expands Livatag® International Phase III Clinical Trial “ReLive” to 3 New Countries

PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Regulatory News:

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ Copenhagen:
ONXEO), an innovative company specializing in the development of orphan oncology
drugs, today announced that Livatag® phase III clinical trial “ReLive” is
expanded to 3 new countries in the Middle-East and North Africa region (MENA).

The ReLive study is an international phase III trial designed to assess
Livatag®’s (Doxorubicin Transdrug™) efficacy on survival in 400 patients with
refractory hepatocellular carcinoma in progression following treatment with
Sorafenib. The study is already implemented in about 65 clinical centers in 8
countries, in Europe and North America, with more than 40% of the patients
having already been randomized. Preliminary data from the “ReLive” study are
expected by early 2017.

Relive phase III trial expansion in line with strategic plan
In line with Onxeo’s strategic expansion plan for the Livatag® “ReLive” phase
III trial, the company is opening up trial centers in three new countries:
Lebanon, Egypt, and the Kingdom of Saudi Arabia (KSA). These new countries are
in addition to the 8 countries where patients are currently being recruited. The
decision to expand the number of countries in the study is based on the
reassuring feedback that has been received from the data safety monitoring board
(DSMB) and the additional funds that Onxeo has available post the recent
successful capital raising. The addition of these 3 new countries is designed to
optimize recruitment rate in the study.

MCT : Specialized CRO for MENA region
Onxeo has engaged MCT, a contract research organization (CRO) specialized in
running clinical trials in the Middle East and North Africa (MENA region), to
implement the trial in the Lebanon, Egypt, and KSA. MCT, which will be driven by
Onxeo´s internal clinical development team, will be in charge of all
administrative procedures as well as the opening and follow-up of new trial
centers. Approximately 10 additional trial centers should be open and the first
patient expected to be enrolled as soon as mid- 2015.

Data Safety and Monitoring Board (DSMB)
The next Data Safety and Monitoring Board (DSMB) session, at which the safety
data from this Phase III trial are reviewed, is scheduled to take place in the
coming weeks. Since the study started, the DSMB has met 5 times and concluded
each time that the trial could be pursued with no modification, which reflects a
good safety profile of Livatag® so far.

“Livatag® is a key program within Onxeo’s orphan oncology portfolio and the
opening of the ReLive trial in an additional region is a critical element of our
strategy to perform the study in a timely manner and as result creates
significant value from this very attractive asset. The launch of the study in
new regions such as MENA also helps to raise awareness about Livatag® with
clinicians at a broader level, which will be extremely important for ensuring
the product’s adoption at a later stage”, said Judith Greciet, CEO of Onxeo.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) or hepatocarcinoma is the most common of the
primary liver cancers (85% to 90%). According to Globocan (2012 data), liver
cancer is the 6th most common cancer in terms of incidence (782,000 new cases
worldwide each year, 5.6% of all new cancer cases) with the 2nd highest
mortality rate (746,000 deaths, 9.1% of the total) after lung cancer. The risk
factors are well known: infection by hepatitis viruses (B and C),
overconsumption of alcohol (another major cause of cirrhosis) and metabolic
diseases, especially obesity, a growing cause of cirrhosis and HCC.

About Livatag®(doxorubicin Transdrug™)

Livatag® (Doxorubicin Transdrug™) is a doxorubicin formulation in the form of
lyophilized nanoparticles of polyisohexylcyanoacrylate (PIHCA).This new
therapeutic approach allows drug resistance to be avoided by short-circuiting
the mechanisms of multi-drug resistance developed by tumor cells through the
masking of the anticancer agent. Acting as a Trojan horse, the nanoparticle
formulation avoids rejection of doxorubicin outside the cell so that it can
exert its cytotoxic action. By specifically targeting tumor cells in the liver
and overcoming resistance to doxorubicin, Livatag® represents a significant
breakthrough in the treatment of this cancer. The first indication of this
product is hepatocellular carcinoma; the 6th most widespread cancer in the world
and the 2nd cause of cancer-related death.

About Onxeo
Onxeo has the vision to become a global leader and pioneer in oncology, with a
focus on orphan or rare cancers, through developing innovative therapeutic
alternatives designed to “make the difference”. The Onxeo team is determined to
develop innovative medicines that provide patients with hope and significantly
improve their lives.

Key orphan oncology products at the advanced development stage are:
Livatag® (Doxorubicin Transdrug™): Phase III in hepatocellular carcinoma
Validive® (Clonidine Lauriad®): Phase II in severe oral mucositis: Positive
preliminary top-line results
Beleodaq® (belinostat): registered in the US in peripheral T-cell lymphoma
For more information, visit the website www.onxeo.com

Disclaimer
This communication expressly or implicitly contains certain forward-looking
statements concerning Onxeo and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors, which could cause the
actual results, financial condition, performance or achievements of Onxeo to be
materially different from any future results, performance or achievements
expressed or implied by such forward-looking statements. Onxeo is providing this
communication as of this date and does not undertake to update any forward
-looking statements contained herein as a result of new information, future
events or otherwise. For a discussion of risks and uncertainties which could
cause actual results, financial condition, performance or achievements of Onxeo
to differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the 2013 Reference
Document filed with the AMF on April 7, 2014, which is available on the AMF
website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).
Onxeo
Judith Greciet, CEO
j.greciet@onxeo.com
or
Nicolas Fellmann, CFO
n.fellmann@onxeo.com
+33 1 45 58 76 00
or
Caroline Carmagnol / Sophie Colin – Alize RP
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 1 44 54 36 62