BioAlliance Pharma has extended its ongoing acyclovir lauriad Phase III trial in the treatment of oral herpes to US. Ten clinical centers have been opened in the country and will join the 40 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 US, 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.
Dominique Costantini, president of the management board at BioAlliance Pharma, said: “With acyclovir lauriad in the US, our objective is to be able to access 60% of the potential market that the product represents.”
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