BioAlliance Pharma SA: Presentation of Phase I clinical results with AMEP® biotherapy in the treatment of metastatic melanoma
02 October 2012 - 2:25AM
Business Wire
Regulatory News:
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), an
innovative Company dedicated to the development of orphan oncology
products and to supportive care products, presented safety and
tolerance results of the phase I clinical study with the AMEP®
biotherapy in the metastatic melanoma at the annual congress of
ESMO (European Society for Medical Oncology) in Vienna, Austria
(September 28th – October 1st).
These results were presented by Dr Julie Gehl (Clinical
Associate Research Professor at University of Copenhagen Department
of Oncology, Herlev Hospital of Copenhagen, Denmark), Principal
Investigator of the study, in the form of an abstract and of a
poster: “Proof of concept of gene therapy using plasmid AMEP in
disseminated melanoma: Safety and efficacy results of a phase I
first-in-man study.” Two other specialized European cancer centers
were also involved in the study: the Gustave Roussy Institute in
Villejuif (France) and the Institute of Oncology in Ljubljana
(Slovenia).
AMEP® targets specific receptors (integrins) particularly
expressed by melanoma cells and vascular endothelial cells, both
involved in tumor growth and tumor angiogenesis (formation of
neovascularization inducing tumour growth). This first phase I
clinical trial, conducted in advanced or metastatic melanoma, has
shown a very good safety profile of the biotherapy administered by
local electrotransfer (intratumoral) as well as satisfactory
signals of efficacy. Based on these positive results, BioAlliance
Pharma is pursuing the development of its biotherapy and obtained
last June the approval of the phase I/II clinical trial application
from the regulatory authorities. This trial, to be conducted on a
European level, aims now at evaluating the safety and efficacy
profile of the AMEP® biotherapy administered via systemic route
(intramuscular) in the same indication.
« The presentation of the first results of AMEP®’s clinical
development at a renowned European oncology congress, shows the
interest and the innovation of a promising and original project
whose clinical development is conducted by specialized European
centers,” declares Dr Bérangère Vasseur, Clinical Development
Director of BioAlliance Pharma.
“This first-in-man study showed that gene electrotransfer of
plasmid AMEP® could be safely administered, and transfection was
obtained in tumors. This represents the successful conclusion of a
European collaboration to perform gene therapy using this novel
agent. Already follow-up studies are approved, and we look forward
to the results of this continued effort to explore novel treatment
paradigms,” declares Dr Julie Gehl.
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 productsLoramyc®/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
statusFentanyl LauriadTM (chronic cancer pain): Positive
preliminary Phase I results
Orphan Oncology productsLivatag® (Doxorubicin Transdrug™)
(primary liver cancer): Phase III on goingValidive® (Clonidine
LauriadTM) (mucositis): Phase II on goingAMEP® (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).
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