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:
Specialty products
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
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 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).
