PARIS--(BUSINESS WIRE)-- Regulatory News:
BioAlliance Pharma SA (Paris:BIO)(Euronext Paris - BIO), a company dedicated to specialty and orphan oncology products, today announces two key steps in the development of its AMEP™ biotherapy with the submission to the French drug agency (Afssaps) of a phase I/II clinical trial in the metastatic melanoma and the grant of a European patent covering the product until 2022.
AMEP™ targets specific receptors (integrins), overexpressed by melanoma cells involved in tumor growth and tumor angiogenesis. Based on the results of a first phase I clinical trial showing a satisfactory safety and a signal of efficacy via local administration in man, BioAlliance Pharma pursues the development of AMEP™ with a European phase I/II trial via intramuscular route in patients with metastatic melanoma.
In addition, after Asia, BioAlliance Pharma has obtained a European patent protecting AMEP™ until 2022. This represents a new step towards the international recognition of the innovation brought by this anticancer therapy.
“The progress in its clinical development, along with the recognition of its original concept strengthen the interest of a particularly innovative therapy, developed in a consortium associating academic research, industrials and melanoma clinicians and co-financed by OSEO's Strategic Industrial Innovation Program to the "Cancer Anti-invasive Program" (CAP)”, declares Judith Greciet, CEO of BioAlliance Pharma. “AMEP™ is one of the 3 “Orphan oncology products” portfolio in clinical phase supporting BioAlliance’s ambition to become a major player in this area”.
About metastatic melanoma
The metastatic melanoma in an invasive skin cancer of bad prognosis. Its strong therapeutic need is still unmet. World Health Organization (WHO) estimates that worldwide there are nearly 200,000 new cases of melanoma and more than 46,000 deaths annually due to melanoma.
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: Authorization for Phase III clinical trial
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).
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
KEYWORDS: Europe France
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical Other Health