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

PARIS & COPENHAGEN, Denmark–(BUSINESS WIRE)–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
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 Author:       Jordi Giralt, M.D., Ph.D.
Head of the Radiation Oncology Service at Vall d’Hebron University
Hospital, Barcelona, Spain
Oral ePoster 16 Discussion:

and Neck V

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®)
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.
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:
(Doxorubicin Transdrug™): Phase III in hepatocellular carcinoma
(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
more information, visit the website

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 (
or on the company’s website (


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