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news.Astellas Pharma, partner of Basilea Pharmaceutica, has started the formal process to allow continuation of patient enrollment into the Phase III clinical studies of Isavuconazole for the treatment of life-threatening invasive fungal infections.
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Basilea Pharmaceutica said that the process to re-open Phase III clinical sites for the Isavuconazole trials has started after the completion of the transfer of the investigational new drug (IND) application and clinical trial sponsorship internationally to Astellas.
The three Phase III studies, one targeting yeast infections (candidemia and other invasive Candida infections), one mold infections (invasive aspergillosis) and a third trial including rare molds infections and renally impaired patients with aspergillosis, are intended to evaluate the safety, tolerability and efficacy of Isavuconazole
After completing the review of the phase III clinical program, Astellas and Basilea have carried out certain study protocol amendments to the invasive aspergillosis study in order to account for changes in clinical practice, the evolving regulatory environment and ongoing advancements in clinical diagnostics.
The treatment of first new patients in the Phase III program is expected in the third quarter of 2010, which is subjected to approvals from local Ethic Committees.
Achim Kaufhold, chief medical officer of Basilea Pharmaceutica, said: “The implementation of these protocol amendments that allow for a swift continuation of patient recruitment and the anticipated expansion of patient numbers underscore Astellas’ and our commitment to pursue the development path for this treatment.”