BioAlliance Pharma accelerates its international clinical research program
Extension to the United States of the acyclovir Lauriad® Phase III trial
Paris, November 28 2007 – BioAlliance Pharma SA (Euronext Paris – ticker code BIO) today announced it has extended its ongoing acyclovir Lauriad® Phase III trial in the treatment of oral herpes to the United States. Ten clinical centers have been opened in the country and will join the forty or so in Australia and Europe already participating in the trial, with a target of 640 patients.
The technology used in the trial (the Lauriad® buccal muco-adhesive tablet) has already proved itself in the company's Loramyc® product. The healing time of herpes lesions after taking a single acyclovir Lauriad® tablet will be compared with placebo. The company is planning to submit market authorization applications in the first half of 2009 in Europe and in the United States, subject to additional regulatory requirements.
Furthermore, after successful completion of patient enrolment in the pivotal phase III clinical trial performed with a view to registering Loramyc® in the US, the company is continuing to open additional European centers for its phase III doxorubicin Transdrug® trial in primary liver cancer.
"This successful international extension of our trials confirms the quality of BioAlliance Pharma's Clinical Research and Regulatory Affairs teams", commented Dominique Costantini, President of the Management Board. "With Acyclovir Lauriad® in the USA, our objective is to be able to access 60% of the potential market that the product represents".
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