May 20, 2012

BioAlliance Pharma SA: Initiation of ReLive, phase III clinical trial with Livatag(R) In primary liver cancer

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PRESS RELEASE

May 14, 2012, 12:00 p.m. EDT

PARIS, May 14, 2012 (BUSINESS WIRE) -- Regulatory News:

BioAlliance Pharma SA (euronext paris:BIO), a Company dedicated to orphan oncology products and specialty products, today announces the initiation of ReLive, its phase III clinical trial with Livatag(R) (doxorubicin Transdrug(TM)), as scheduled in the advancement calendar of the project. This international, multicenter, randomized phase III trial aims at evaluating the efficacy of Livatag(R) on overall survival in nearly 400 patients suffering from Hepato Cellular Carcinoma, resistant or intolerant to sorafenib.

Almost 15 French sites expert in hepatology are already initiated and able to start recruiting the first patients. In the short and middle term, BioAlliance Pharma plans to extend the study to about 30 sites in France and abroad.

"Primary liver cancer is a particularly severe cancer and the need for efficacious treatments in advanced stage of the disease is major to improve patients' survival", declares Pr. Philippe Merle, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Principal Investigator of the study. "Livatag(R) represents a different therapeutic approach, as compared with targeted therapies currently under evaluation. Its nanoparticle formulation enables Livatag(R) to bypass the resistance mechanisms of the tumor cell and assign it an interesting activity. This clinical trial should confirm it."

The clinical trial batches of Livatag(R) have been performed by qualified companies for injectable cytoxic products in nanoparticle form, in collaboration with the BioAlliance Pharma's team specialized in industrial development that ensured the transmission of its know-how specific to nanoparticle Transdrug(TM) technology, and followed throughout the process. The clinical batches will be sent to the investigating sites in the next days.

At last, the European independent Board of experts of the ReLive trial has met, with Pr. Michel Beaugrand (Jean Verdier University Hospital, Paris) as President and Pr. Jordi Bruix (Hospital Clinic i Provincial, Barcelona), as Vice-President. It will perform a regular monitoring of the study.

"All necessary authorizations and conditions are now in place to enable us to actually start the ReLive trial; the investigators can now screen and treat their first patients. The need for alternative therapeutics in primary advanced liver cancer is crucial and this trial should enable to establish the efficacy and the tolerance of Livatag(R) in this indication. This last step of the product development is now launched, barely one year after announcement of the phase II preliminary results, and in line with the expected schedule, this is a substantial team performance", comments Judith Greciet, CEO of BioAlliance Pharma. "Livatag(R) is the leader of our "Orphan Oncology product" portfolio, core of the Company's growth strategy, and represents a very strong asset for BioAlliance, with a sales potential above 800 million Euros. Implementation and realization of ReLive are indeed key steps to value this Company's strong asset".

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:

Specialty products

Loramyc(R)/Oravig(R) (oropharyngeal candidiasis in immunocompromised patients): Registered in 28 countries (EU, US, Korea)

Sitavir(R) (Acyclovir Lauriad(TM)) (labialis herpes): Positive phase III final results; registration status

Fentanyl Lauriad(TM) (chronic cancer pain): Positive preliminary Phase I results

Orphan Oncology products

Livatag(R) (Doxorubicin Transdrug(TM)) in primary liver cancer: Authorization for Phase III clinical trial

Clonidine LauriadTM (mucositis): Phase II on going

AMEP(R) (invasive melanoma): Phase I on going

For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com

Disclaimer

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 ).

SOURCE: BioAlliance Pharma SA

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