BioAlliance Pharma SA (Euronext Paris – BIO), a Company
dedicated to specialty and orphan pharma products in oncology and supportive care, today
announces new achievements in its phase II clinical trial with clonidine Lauriad™.
This trial, in which more that 30% of planned patients are already included, aims at
evaluating the efficacy and tolerance of clonidine Lauriad™ in the prevention and the
treatment of radio/chemotherapy-induced oral mucositis in patients with head and neck
cancer. To date, the participating centers have not reported any particular toxicity related to
the product and they confirm their interest in this study.
Thus, BioAlliance Pharma is planning to enlarge the trial, already ongoing in France,
Germany and Spain, to 4 other European countries in the next weeks. This expansion to
about 50 active centers will enable to accelerate the recruitment in the trial that should be
finalized in 2013.
Oral mucositis is a particularly invalidating pathology occurring in 60% of patients treated
with radio/chemotherapy for head and neck cancer. It may induce intense oral pain and
eating disability requiring artificial nutritional support. 20 to 30% of patients have to be
hospitalized and more than 10% of them require a modification or a stop of the radiotherapy
treatment*. Radiotherapy-induced oral mucositis has currently no preventive cure.
“ Clonidine Lauriad™, that has been granted the “orphan designation” in Europe last
October, is a high potential asset of our “orphan oncology products” portfolio”, declares
Judith Greciet, CEO of BioAlliance Pharma. “Beyond optimizing the product development,
the expansion of our trial in Europe enables us to already involve a great number of
specialists, part of our future prescriber network”.
* Trotti et al, 2003