BioAlliance Pharma Announces Two New Key Steps in the Development of Its AMEP® Biotherapy
April 26 2012 - 12:00PM
Business Wire
Regulatory News:
BioAlliance Pharma SA (Euronext Paris - BIO), a company
dedicated to orphan oncology products and specialty products, today
announces the validation by the French drug agency (Afssaps) of its
application for a phase I/II clinical trial with Amep® in the
metastatic melanoma, and the signature of a partnership agreement
for the development of its biotherapy with the Department of
Oncology of the Herlev Hospital of Copenhagen.
Submitted end of January 2012, the phase I/II clinical trial
application follows the positive preliminary results of a first
phase I trial via local administration (intratumoral) in patients
with metastatic melanoma. This phase I/II trial, to be conducted on
a European level, aims at evaluating the safety and efficacy
profile of the Amep® biotherapy via systemic route (intramuscular)
in the same indication. The growing incidence of metastatic
melanoma and the short survival duration of patients make this
cancer a disease with a very strong therapeutic need.
Moreover, BioAlliance Pharma and the Herlev Hospital of
Copenhagen have recently signed a partnership agreement to conduct
a complementary phase I clinical trial with Amep® in Denmark. This
trial, currently under evaluation by the Danish Medicines Agency,
aims at evaluating the safety and the efficacy of the Amep®
biotherapy in patients with different types of metastatic solid
tumors. It will be conducted by Dr Julie Gehl, Oncologist, Clinical
Associate Research Professor at University of Copenhagen, who was
already actively involved in the first phase I trial via local
route, and thus reinforces the development plan of this asset.
“As planned, we are pursuing the European development of a
particularly innovative therapy, developed and valued in a
consortium associating academic research, industrials and melanoma
clinicians, and co-financed by OSEO's Strategic Industrial
Innovation Program”, declares Judith Greciet, CEO of BioAlliance
Pharma. “The collaboration with a great European oncology centre,
in partnership with Dr Julie Gehl, to evaluate the interest of
Amep® in other types of cancers is an interesting opportunity that
reinforces the value of this key asset. The receivability of the
phase I/II trial via intramuscular route, together with this
partnership agreement, represent two key achievements in the
clinical development of Amep®, an original biotherapy of our
strategic portfolio”.
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® (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™)
in primary liver cancer: Authorization for Phase III clinical
trialClonidine 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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