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 19th, 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.
« This first recommendation is a very positive and encouraging sign for the safety profile evaluation of Livatag® and consequently for the pursuit of the study,” comments Judith Greciet, CEO of BioAlliance Pharma. “Livatag® is the leader of our “Orphan Oncology product” portfolio, core of the Company’s growth strategy. It represents a very strong asset for BioAlliance and ReLive is a key milestone that enhances its value.”
About 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 LauriadTM) (labialis herpes): Positive phase III final results; registration status
Fentanyl LauriadTM (chronic cancer pain): Positive preliminary Phase I results
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (Clonidine LauriadTM) (mucositis): Phase II on going
AMEP® (invasive melanoma): Phase I on going
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com
This communication expressly or implicitly contains certain forward-looking statements concerning BioAlliance Pharma SA 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 BioAlliance Pharma SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioAlliance Pharma SA 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 BioAlliance Pharma SA to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2011 Reference Document filed with the AMF on April 24, 2012, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
Judith Greciet, +33 1 45 58 76 00
Nicolas Fellmann, +33 1 45 58 71
Caroline Carmagnol, +33 6 64 18 99 59
Christian Berg, +33 1 42 68 86 41
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