Onxeo: Belinostat Abstracts for American Association for Cancer Research 2015

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 preclinical and clinical data on belinostat will be presented at the 2015 American Association for Cancer Research (AACR) Annual Meeting (April 18-22, 2015) in Philadelphia (Pennsylvania), USA.

Preclinical and clinical abstracts involving belinostat will be featured at the AACR 2015. To be highlighted are especially abstracts no. 114 and 5480. Abstract no. 114 concerns the mass balance study of ¹⁴C-belinostat in patients with recurrent or progressive malignancy. The aim of the study is to evaluate the excretion (mass balance) and pharmacokinetics of belinostat and to further understand the drug’s metabolism. The study is a post-marketing requirement study set by the US Food and Drug Administration (FDA). The study’s top-line results show that the study was positively conducted. Abstract 5480 concerns the clinical toxicity of belinostat, which shows that belinostat has a good safety profile.

The studies supporting these abstracts were conducted on belinostat in different cancer indications and have generated relevant and robust preclinical and clinical data on the product’s profile, alone or in combination with other chemotherapies. These first data will much help supporting and finalizing the best development plan for belinostat and already advocate for the selection of new promising orphan oncology indications.

The involvement of the large number of investigators in these studies demonstrates the scientific and clinical interest on the product and is encouraging for the future potential of clinical sites to enroll.

"Already registered and marketed in the US for the treatment of peripheral T-cell lymphoma, belinostat has furthermore a strong potential research focus and several potential cancer indications. The product’s development plan is being built based on these assets and perfectly fits with our strategy to build a robust and diversified pipeline focused on the orphan oncology”, comments Judith Greciet, CEO of Onxeo.

Please see the abstracts, that are now available on AACR’s website (http://www.aacr.org/).

About the AACR

The American Association for Cancer Research (AACR) is the first and largest cancer research organization in the world. The Philadelphia-based nonprofit organization was founded in 1907 by a group of 11 physicians and scientists interested in research "to further the investigation and spread the knowledge of cancer." 

The mission of the AACR is to understand, prevent, diagnose, treat, and cure cancer by promoting research, education, communication, and collaboration. To that end, the AACR focuses on every facet of high-quality, innovative cancer research.

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 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 2014 Reference Document filed with the AMF on April 14, 2015, which is available on the AMF website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).