BioAlliance Pharma : First Meeting of the International Advisory Board on Oral Mucositis and Development of Validive®
September 30 2013 - 11:55AM
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, held the first meeting of
its international Advisory Board dedicated to oral mucositis and to
the associated clinical development program with Validive®
(clonidine Lauriad®).
This multidisciplinary Advisory Board is composed of
internationally recognized European and American experts, in the
fields of oral mucositis and oral medicine, oncology and
radiotherapy: Drs Stephen Sonis (Boston, Massachusetts), Paolo
Bossi (Milano, Italy), Joel Epstein (LA, California), Jorge Giralt
Lopez del Segredo (Barcelona, Spain) and Michael Henke (Freiburg,
Germany). Its purpose is to provide advice and input on development
strategy and medical positioning of Validive® in oral
mucositis.
Validive® is currently being developed for the prevention and
treatment of chemoradiation therapy-induced oral mucositis in
patients with head and neck cancer. The Phase 2 international,
double blind, placebo controlled study being conducted in Europe
and in the US has enrolled nearly 75% of planned patients.
Recruitment should be completed early in 2014 with results and
analyses completed later in the year expected to represent a major
step towards the validation of Validive®. The Advisory Board will
assist BioAlliance Pharma with Validive®’s development strategy and
has started assessing the most relevant strategic path from ongoing
Phase II to registration.
“Validive®’s biological activities are consistent with the
interruption of pathways known to be important in the development
of mucositis. Coupled with its unique formulation, Validive® could
become an attractive option for the prevention of oral mucositis, a
severe treatment complication for which no preventive treatment is
currently available,” comments Stephen Sonis.
“Moreover, this panel of worldwide scientific and medical
experts in oncology treatment-induced oral mucositis will help us
design the future trials with Validive®, a key asset in our Orphan
Oncology portfolio, to meet patients’ needs and help us to maximize
the potential of Validive® in this disabling disease,” adds Pierre
Attali, BioAlliance Pharma’s Chief Operating Officer in charge of
strategy and medical affairs.
About Severe Oral MucositisSevere oral mucositis is a
particularly invalidating pathology occurring in more than 60% of
patients treated with radio/chemotherapy for head and neck cancer
and has currently no validated curative or preventive treatment. It
may induce intense oral pain and eating disability requiring
enteral or parenteral nutritional support. Thirty percent of
patients need to be hospitalized as a result and symptoms can force
patients to stop treatment for an undefined period thus reducing
treatment efficacy.
About BioAlliance PharmaDedicated to cancer and
supportive care treatment with a focus on resistance targeting and
orphan products, BioAlliance Pharma 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 26
countries (EU, US, Korea), commercialized in Europe and in the
US.Sitavig® (Acyclovir Lauriad®) (labialis herpes): Registered in
the US and in 8 European countries, registration status in the
other European countries.Fentanyl Lauriad® (chronic cancer pain):
Positive preliminary Phase I results
Orphan Oncology productsLivatag® (Doxorubicin Transdrug™)
(primary liver cancer): Phase III on goingValidive® (Clonidine
Lauriad®) (mucositis): Phase II on goingAMEP® (invasive melanoma):
Phase I on goingFor 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 2012 Reference Document filed
with the AMF on April 18, 2013, 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 SAJudith Greciet,
CEOjudith.greciet@bioalliancepharma.comorNicolas Fellmann, Tel.:
+33 1 45 58 76
00CFOnicolas.fellmann@bioalliancepharma.comorALIZE
RPCaroline Carmagnol, +33 6 64 18 99
59caroline@alizerp.comorChristian Berg, +33 6 31 13 76
20christian@alizerp.com
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