BioAlliance Pharma: Presentation of Livatag Survival Results at the International Liver Cancer Congress in Hong Kong
PARIS--(BUSINESS WIRE)--Sep 5, 2011 - Regulatory News: BioAlliance Pharma SA (Paris:BIO), a company dedicated to specialty and orphan oncology products, today announces oral communication of the Phase II clinical trial results of its orphan product Livatag® at the annual congress of ILCA (International Liver Cancer Association), the only international organization devoted exclusively to liver cancer research with participation of worldwide best specialists.
Pr. Philippe Merle, Professor of hepatology at the Hospices Civils de Lyon and principal investigator of the Phase II trial, presented preliminary survival results observed in patients with unresectable hepatocellular carcinoma (primary liver cancer). Out of the total 50 patients planned, 28 were randomized and have received intra-arterial injection of Livatag® (n=17) or chemoembolization (n=11), according to a 2/1 scheme (2 patients with Livatag® for 1 patient with chemoembolization). Livatag® was administered every 4 weeks, up to 3 injections.
Although the trial had been put on hold due to severe pulmonary adverse events, the assessment of survival has been continued based upon the recommendation of the Independent Data Safety Monitoring Board.
The survival results for patients treated with Livatag® showed a significant increase compared to the control group with 31.7 months median survival versus 15 months (p<0.05). Patients who received 3 injections had an even better response with an increased median survival (33 versus 15 months) (p<0.05).
Pr. Philippe Merle concluded on the promising opportunities offered by the new slow intravenous administration route, enabling a better control of pulmonary effects, considering the substantial survival benefits showed in a pathology where therapeutic solutions are rare.
These results have also been accepted for a presentation during the AFEF (Association Française pour l'Etude du Foie) congress in Paris, from September 28 to October 1, 2011.
« Livatag® is the leading product of our « orphan oncology products » portfolio that comprises also two other products in clinical phase (clonidine Lauriad™ in phase II in the treatment of mucositis and AMEP™, in phase I in the treatment of metastatic melanoma)”, declared Judith Greciet, CEO of BioAlliance Pharma. “This development strategy in an orphan disease is a key driver of the Company growth. The strong interest for Livatag® from the scientific and medical community confirms our choice to expand in such area where there is a crucial medical need”.
Primary liver cancer, or hepatocellular carcinoma, is the fifth cancer in incidence and the third leading cause of cancer deaths worldwide. This cancer is highly chemo-resistant, very often diagnosed at an advanced stage and still represents a high unmet medical need. Livatag® is a treatment presented in nanoparticles able to deliver doxorubicin in chemoresistant cells. Livatag® was granted an orphan drug status in Europe and in the United States.
Livatag® is today the leader in the orphan oncology products portfolio, also including clonidine Lauriad™ in the prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer (phase II) and AMEP® in metastatic melanoma (phase I).
The Association Française pour l'Etude du Foie is a medical society that promotes the development of hepatology in France and in French speaking countries through scientific meetings among hepatologists and publications.
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; the products' commercialization rights are licensed to international commercial partners invested in the hospital setting. In areas where medical needs are insufficiently met, its targeted approaches help overcome drug resistance and improve patient health & quality of life.
BioAlliance Pharma has developed an advanced product portfolio:
Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 28 countries (EU US, Korea)
Sitavir® (Acyclovir Lauriad TM) (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™) in primary) liver cancer: Phase II results on survival
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 2010 Reference Document filed with the AMF on April 7, 2011, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
Contact: BioAlliance Pharma SA
Judith Greciet, CEO
Tel +33 1 45 58 76 00
Nicolas Fellmann, CFO
Tel.: +33 1 45 58 71 00
Tel.: +33 6 64 18 99 59
Posted: September 2011