BioAlliance Pharma: First meeting of the DSMB of the ReLive trial and continuation without modification of the Phase III clinical trial with Livatag® in primary liver cancer

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Judith Greciet, +33 1 45 58 76 00CEOorNicolas Fellmann, +33 1 45 58 71CFOorCaroline Carmagnol, +33 6 64 18 99 59orChristian Berg, +33 1 42 68 86 41

Regulatory News:

BioAlliance Pharma SA (Euronext Paris - BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces that the European Independent Board of Experts (Data Safety and Monitoring Board, DSMB) held its first meeting on the ReLive Phase III trial and recommended continuing it without modification to evaluate the efficacy of Livatag (doxorubicin Transdrug™) in primary liver cancer.

In order to ensure a regular safety monitoring of patients enrolled in ReLive, the organization of a Board of international experts was to meet every 6 months, and/or after inclusion of the first 25 patients, to review the safety data of patients included in the trial, and to recommend possible modifications of the protocol. This type of Board is usually organized in pivotal phase III clinical trials to assure patient safety and integrity of the trial.

Therefore, on November 19, and 6 months after the study initiation, BioAlliance Pharma held its Board of Experts meeting which, based on the data review from the first patients included and treated, unanimously recommended continuing the trial without modification

This international, multicenter, randomized clinical trial aims at evaluating the efficacy of Livatag on overall survival in nearly 400 patients suffering from Hepato Cellular Carcinoma, resistant or intolerant to sorafenib. Almost 20 French sites expert in hepatology are initiated. BioAlliance Pharma is planning to extend the study abroad in the short to medium term.

comments Judith Greciet, CEO of BioAlliance Pharma.

Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.

Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA.

BioAlliance Pharma has developed an advanced product portfolio:

Loramyc/Oravig (oropharyngeal candidiasis in immunocompromised patients): Registered in 28 countries (EU, US, Korea)Sitavir/Sitavig (Acyclovir Lauriad) (labialis herpes): Positive phase III final results; registration statusFentanyl Lauriad (chronic cancer pain): Positive preliminary Phase I results

Livatag (Doxorubicin Transdrug™) (primary liver cancer): Phase III on goingValidive (Clonidine Lauriad) (mucositis): Phase II on goingAMEP (invasive melanoma): Phase I on going

For more information, visit the BioAlliance Pharma web site at

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