Onxeo S.A.: Phase II trial results of Validive® presented at the ASCO Conference

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 Validive® (clonidine Lauriad®) phase II clinical trial results have been accepted for a poster presentation at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO).

The ASCO annual meeting is a major event in the field of oncology that brings together 30,000 health professionals and updates on the major latest steps and results achieved in oncology worldwide. The event will be taking place in Chicago (USA), from May 29 to June 2, 2015.

Late October 2014, Onxeo reported positive preliminary top-line results of the large international Phase II clinical trial with Validive® in the prevention of oral mucositis in patients undergoing head and neck cancer treatment. They showed a reduction in the incidence of severe oral mucositis with a very good safety. Based on these data, the trial’s Board of experts has confirmed the interest of pursuing the development of Validive® with the initiation of a Phase III trial to evaluate the product’s efficacy. The company plans to initiate this trial in 2015.

"We are very pleased to have this presentation at the ASCO meeting, an opportunity to share the phase II clinical trial results of Validive® with the scientific community. The selection of our abstract emphasizes the expertise of our clinical development team and the quality of the data. It also confirms the interest of a key product of our orphan oncology portfolio that meets an unmet medical need in an invalidating pathology,” comments Judith Greciet, CEO of Onxeo.

About Severe Oral Mucositis

Severe oral mucositis is a particularly invalidating pathology occurring in more than 60% of patients treated with radio/chemotherapy for head and neck cancer and has currently no validated curative or preventive treatment. It may induce intense oral pain and eating disability requiring enteral or parenteral nutritional support. Thirty percent of patients need to be hospitalized as a result and symptoms can force patients to stop treatment for an undefined period thus reducing treatment efficacy.

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).