An initial Phase I pharmacokinetics, biodistribution and dosimetry study (BC1-08) with Alpharadin in HRPC patients with skeletal metastases will be conducted at the Memorial Sloan-Kettering Cancer Center in New York. This US trial will further expand the information obtained in a similar Phase I study (BC1-05) conducted at the Royal Marsden Hospital in London, for which patient enrolment has recently been completed.
Algeta has filed its investigational new drug application for its lead product Alpharadin with the FDA in December 2007. The statutory 30 day consultation period was extended by the FDA for a further 30 days by agreement with the company and the IND has now been cleared by the FDA without any objections being made to the application.