PARIS--(BUSINESS WIRE)--Regulatory News :
BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), a Company dedicated to the development of orphan oncology products and supportive care products, announces the initiation of its Phase II clinical trial evaluating the efficacy and safety of Validive® (clonidine Lauriad®) in the United States in patients with chemoradiation therapy-induced oral mucositis with head and neck cancer, as scheduled in the advancement calendar of the project.
Further to IND approval by the United States Food and Drug Administration (FDA), the first investigational sites have been initiated in May in the U.S. and are ready to start recruiting patients. About twenty sites are planned to be initiated in the U.S. in the coming weeks.
“This extension was set up thanks to our teams’ involvement and to a marked interest of clinicians from major U.S. centers specialized in oncology and radiotherapy for Validive®, a drug that meets a strong medical need in a pathology with currently no preventive validated treatment,” declares Judith Greciet, CEO of BioAlliance Pharma.
The clinical trial is also being conducted in Europe in about thirty centers in 4 countries: France, Germany, Spain and more recently Hungary.
So far, more than 60% of planned patients have been enrolled in Europe and the U.S. extension is planned to help accelerate the recruitment. The trial is expected to be finalized in late 2013/early 2014 with results in 2014.
“Thanks to the initiation of additional sites, especially in the United States, the acceleration of the Validive® clinical trial enables the expectation of results as soon as next year. This is a crucial step to firmly validate the efficacy of Validive® in the severe oral mucositis, strongly reinforcing the value of this leading drug of our orphan oncology portfolio,” adds Judith Greciet.
Severe oral mucositis occurs in more than 60% of patients treated with radio/chemotherapy for head and neck cancer, and currently has no validated curative or preventive treatment. It may induce intense oral pain and eating disability leading to hospitalization and enteral or parenteral nutritional support. The disease also frequently requires stopping, sometimes for a prolonged period, the cancer treatment protocol, thus strongly impacting treatment efficacy for the patient.
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:
Loramyc®/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 products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (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
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).