Onxeo Announces Positive DSMB Recommendation for Its Phase III Trial with Livatag® in Primary Liver Cancer

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

Onxeo SA (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen
- ONXEO), an innovative company specializing in the development of orphan
oncology drugs, today announced that the European Independent Board of Experts
(Data Safety and Monitoring Board, DSMB) in charge of the safety monitoring of
the Livatag® Phase III trial has once again unanimously recommended continuing
the study without modification.

“Each new positive recommendation from our DSMB further strengthens our
confidence about Livatag® safety profile and confirms that so far, the product
safety profile is as expected. This is of course of great importance for one of
our most promising programs”, comments Judith Greciet, CEO of Onxeo.

ReLive is an international, randomized Phase III trial aiming at demonstrating
the efficacy of Livatag® on survival in 400 patients with advanced
HepatoCellular Carcinoma (primary liver cancer) after failure of intolerance to
Sorafenib.

The Data Safety and Monitoring Board meets every 6 months to review the safety
data of the ReLive trial and consequently makes recommendations on the conduct
of the study. As in previous safety evaluations since trial’s initiation, the
DSMB unanimously recommended to continue the study without modification, based
on its positive assessment of the safety data of Livatag®. This fully positive
recommendation confirms once more the good safety profile of the product.

About HepatoCellular carcinoma
Hepatocellular carcinoma (HCC), or hepatocarcinoma, is the most common of the
primary liver cancers (85% to 90%). It is an aggressive cancer which is
resistant to chemotherapy. It is the 2nd highest cause of death from cancer
worldwide. It is commonly diagnosed at an advanced stage at which time few
therapeutic alternatives exist, presenting a strong therapeutic need. 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 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 to “make the difference”. The Onxeo teams are determined to develop
innovative medicines to provide patients with hope and significantly improve
their lives.

Key products at 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).
Contacts
Onxeo
Judith Greciet, CEO
j.greciet@onxeo.com
or
Nicolas Fellmann, CFO
n.fellmann@onxeo.com
+33 1 45 58 76 00
or
Alize RP
Caroline Carmagnol / Sophie Colin, +33 6 64 18 99 59 / +33 1 44 54 36 62
caroline@alizerp.com / scolin@alizerp.com