News Archive
21.February 2008
Algeta receives IND approval for Alpharadin to commence clinical development in the USA

Oslo, Norway, February 21st 2008 - Algtea ASA,  the cancer therapeutics company, today announced that it will shortly commence clinical development of Alpharadin in HRPC patients in the USA.  Algeta filed Investigational New Drug (IND) application for its lead product Alpharadin with the United States Food and Drug Administration (FDA) in December 2007.  The statutory 30 days consultation period was extended by the FDA for a further 30 days period by agreement with the company and the IND has now been cleared by the FDA without any objections being made to the application.  Alpharadin has already been studied in phase II significant trials in Europe and has demonstrated a potential for significant survival benefit in hormone-refractory prostate cancer (HRPC) patients with skeletal metastases.

An initial Phase I pharmacokinetics, biodistribution and dosimetry study with Alpharadin i HRPC patients with skeletal metastases will be conducted at the Memorial Sloan-Kettering Cancer Center in New York,  one of the world's leading oncology centers. Following the start up of this trial, Algeta will continue discussions with the FDA to agree on the design of the furthre clinical development program for Alpharadin.