Regulatory News :
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), an innovative
Company dedicated to the development of orphan oncology, announced today
that Validive® (clonidine Lauriad®) received a Fast Track designation
from the U.S. Food and Drug Administration (FDA) for the prevention and
treatment of oral mucositis induced by radiotherapy and/or chemotherapy
in cancer patients.
The Fast Track procedure is designed to facilitate interactions with the
FDA and optimize the development time and review period for drugs
investigated as treatments for serious or life- threatening diseases
with a high unmet medical need.
Severe oral mucositis is a highly disabling disease, induced by
intensive radiochemotherapy protocols, particularly frequent in patients
treated for head and neck cancer. At severe stage, it induces intense
oral pain and eating disability, requiring enteral or parenteral
nutritional support. Hospitalization is needed in about 30% of patients
and symptoms can lead to anticancer treatment breaks or delays,
impacting overall chance of success for the treatment. No validated
curative or preventive treatment is currently available.
“The FDA’s decision to grant Fast Track Designation to Validive®
reflects FDA’s awareness about the seriousness of oral mucositis
disease, the strong need for an effective treatment and Validive®’s
potential to address this highly disabling disease. This designation is
key for Validive® development, it will allow an accelerated review
period by the FDA at the time where we are finalizing our large
international double blind phase II trial. Last patient is planned to be
enrolled in the coming weeks and top line data should be issued in the
second half of the year. Validive® is the second most advanced product
of our orphan oncology program, which drives the company growth. The
achievement of the phase II program is a major step to be achieved soon
for one of our key assets”, commented Judith Greciet, CEO of
BioAlliance Pharma.
Validive® (clonidine Lauriad®) is a mucoadhesive tablet based on our
Lauriad® technology that delivers high concentrations of an
anti-inflammatory active principle (clonidine) directly in the oral
cavity, the site of irradiation in the treatment of head and neck cancer.
About BioAlliance Pharma
Dedicated to cancer treatments with a focus on resistance targeting and
orphan products, BioAlliance Pharma conceives and develops innovative
products 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:
Orphan Oncology products
Livatag® (Doxorubicin
Transdrug™) (primary liver cancer): Phase III on going
Validive®
(Clonidine Lauriad®) (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 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 (www.bioalliancepharma.com).
Copyright Business Wire 2014