Onxeo Validive® Abstract Accepted for Oral Presentation at ASTRO Annual Meeting 2015

PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE (http://www.businesswire.com/))--
Regulatory News:

Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), an innovative company specializing
in the development of orphan oncology drugs, today announced that an abstract
supporting the clinical evaluation of Validive® (Clonidine Lauriad®), a
mucoadhesive buccal tablet developed for the prevention and treatment of chemo
-radioation therapy-induced severe oral mucositis (SOM) in patients with head
and neck cancer, has been accepted for oral presentation at the
upcoming 57th American Society for Radiation Oncology (ASTRO) Annual
Meeting (http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.as
t 
ro.org%2FMeetings-and-Events%2F2015-Annual
-Meeting%2FIndex.aspx&esheet=51203425&newsitemid=0&lan=en
-US&anchor=57th+American+Society+for+Radiation+Oncology+%28ASTRO%29+Annual+Meeti
n 
g&index=1&md5=f497af310fd3fbc3835f1452861beb6b), being held October 18-21, 2015
in San Antonio, TX.

In an oral presentation during the ePoster 16 Discussion Session “Head and Neck
V” on Wednesday, October 21, Dr. Jordi Giralt, M.D., Ph.D., Head of the
Radiation Oncology Service at Vall d’Hebron University Hospital in Barcelona,
Spain, and investigator of the Validive® Phase 2 trial, will discuss compliance
and patient acceptability of Validive® findings from the global Phase 2
randomized double-blind, placebo-controlled study.

Logistical details for the oral presentation and poster session include:

Title: Compliance and Patient Acceptability of Clonidine Mucoadhesive Buccal
Tablet (Clonidine Lauriad) to Prevent Severe Radiomucositis in Head and Neck
Cancer Patients

Presenting            Jordi Giralt, M.D., Ph.D.
Author:
                      Head of the Radiation Oncology Service at Vall d’Hebron
University
                      Hospital, Barcelona, Spain

Oral                  Head and Neck
ePoster
V (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fonlin
16
Discussion:           e.myiwf.com%2Fastro2015%2FS
                      essions.aspx%3FID%3D10652%26sp%3D
-1&esheet=51203425&newsitemid=0&lan=en
                     
-US&anchor=Head+and+Neck+V&index=2&md5=61816f9aa6ea67c8f82a 
db0d3e359553)

                      Presentation # 1139
                      Wednesday, October 21, 2015
                      10:45 a.m. – 12:15 p.m. CT
                      Room 102 A/B, Henry B. Gonzalez Convention Center

About Validive® (Clonidine Lauriad®)
Validive® is a therapeutic application of clonidine based on the mucoadhesive
technology Lauriad®. Onxeo’s proprietary Lauriad® technology significantly
increases the mucous and salivary concentrations of the active ingredient it
contains, with decreased systemic absorption.
As an agonist of the alpha-2 adrenergic receptors, Validive® exhibits anti
-inflammatory properties, and was developed for the prevention and treatment of
chemoradioation therapy-induced severe oral mucositis in patients with head and
neck cancer. Preclinical studies and a Phase II trial have confirmed Validive’s
mechanism of action and demonstrated that the therapy significantly reduces
incidence of severe mucositis, improves oral mucositis-related symptoms and
decreases radiotherapy-related adverse events, and exhibits a favorable safety
profile and strong adherence to treatment. Based on these results, the trial
Advisory Board approved a Phase III trial, which Onxeo plans to initiate by end
2015
Validive® was granted orphan drug status in Europe in November 2011 and also
received Fast-Track status from the U.S. Food and Drug Administration (FDA) in
January 2014.

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
final results
Beleodaq® (belinostat): registered in the US in 2nd line treatment of peripheral
T-cell lymphoma
For more information, visit the
website www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3
A 
%2F%2Fwww.onxeo.com&esheet=51203425&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=3&md5=b7adec56381c1f2c30c6a8cb593539da)

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 2014 Reference
Document filed with the AMF on April 14, 2015, which is available on the AMF
website (http://www.amf
-france.org (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww
. 
amf-france.org&esheet=51203425&newsitemid=0&lan=en
-US&anchor=http%3A%2F%2Fwww.amf
-france.org&index=4&md5=1ae5be7cb0579a26a1f6ca4722afe63b)) or on the company’s
website
(www.onxeo.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2F
w 
ww.onxeo.com&esheet=51203425&newsitemid=0&lan=en
-US&anchor=www.onxeo.com&index=5&md5=20b444e6a93263b7c97e81786a449a27)).
Contacts

Onxeo S.A.
Judith Greciet, CEO
j.greciet@onxeo.com
Nicolas Fellmann, CFO
n.fellmann@onxeo.com
+33 1 45 58 76 00
or
Caroline Carmagnol / Florence Portejoie – Alize RP (France)
onxeo@alizerp.com
+33 6 64 18 99 59 / +33 1 44 54 36 64
or
Kirsten Thomas / Lee Roth – The Ruth Group (U.S.)
kthomas@theruthgroup.com / lroth@theruthgroup.com
+1 508 280 6592 / +1 646 536 7012