Onxeo: Belinostat Phase I/II Results in Soft Tissue Sarcoma to Be Presented at the 2015 Annual ASCO Meeting

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 the phase I/II clinical trial of belinostat in combination
with doxorubicin (PXD101-CLN-14) in patients with soft tissue sarcoma (STS) was
accepted for presentation in the Poster Discussion Session at the 2015 Annual
Meeting of the American Society of Clinical Oncology (ASCO), taking place in
Chicago, USA from May 29 to June 2, 2015. The PXD101-CLN-14 study was an open
-label, multicenter, dose-escalation phase I/II to evaluate the safety and
efficacy of the combination of belinostat with doxorubicin in patients with
advanced solid tumors (the phase I part of the study) and STS (the phase II part
of the study). The trial demonstrated that belinostat in combination with
doxorubicin has an acceptable safety profile, allowing the combination of
belinostat at the dose of 1000 mg/m2 on days 1-5 with 75 mg/m2 doxorubicin on
day 5 in a three-week schedule. Signals of efficacy in STS patients were also
demonstrated, in this highly severe disease. “We are delighted to be able to
present belinostat data at ASCO, which is a recognition for the team’s quality
work. These additional clinical data complete and reinforce our knowledge and
understanding of belinostat, as a anti-cancer compound and on its potential
association with a standard chemotherapy like doxorubicin. This is of great
interest while we are finalizing Beleodaq’s development plan”, comments Judith
Greciet, CEO of Onxeo. In July 2014, belinostat (Beleodaq®) was granted
accelerated approval in the USA by the Food and Drug Administration (FDA) for
the treatment of patients with relapsed or refractory peripheral T-cell lymphoma
(PTCL) in 2nd-line treatment after failure of standard chemotherapy. A phase III
trial is planned to be initiated in H1 2016 to expand the indication from 2nd to
1st line of treatment of PTCL in collaboration with Onxeo’s US partner, Spectrum
Pharmaceuticals, Inc. Beyond PTCL, belinostat’s profile, supported by clinical
data, advocates for its development in new promising orphan oncology
indications. The company is currently reviewing potential indications in order
to define the optimal development plan for belinostat. About soft tissue sarcoma
(STS) Sarcomas are a group of solid tumors in the connective tissue of the body
that are treated with surgery, chemotherapy, and/or radiation. Reported
objective response rates are very low with complete responses being rare or
absent in the trials that have led to the registration of anticancer treatments
in this indication over the past six years. Doxorubicin as a single agent or in
combination with ifosfamide is the most commonly used chemotherapeutic regimen
in patients with advanced STS. 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).
Contacts Onxeo Judith Greciet, CEO j.greciet@onxeo.com 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 onxeo@alizerp.com