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Algeta Receives IND Approval for Alpharadin(TM) to Commence Clinical Development in the USA
Date:2/21/2008

OSLO, February 21 /PRNewswire-FirstCall/ -- Algeta ASA (OSE: ALGETA), the cancer therapeutics company, today announced that it will shortly commence clinical development of Alpharadin(TM) in HRPC patients in the USA. Algeta filed its Investigational New Drug (IND) application for its lead product Alpharadin(TM) with the United States Food and Drug Administration (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. Alpharadin(TM) has already been studied in phase II clinical trials in Europe and has demonstrated a potential for a significant survival benefit in hormone-refractory prostate cancer (HRPC) patients with skeletal metastases.

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, one of the world's leading oncology centers. 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.

Following the start up of the BC1-08 trial, Algeta will continue discussions with the FDA to agree on the design of the further clinical development program for Alpharadin(TM)

"We are delighted to have been given the clearance by FDA to advance Alpharadin into clinical development in the United States, and to be working with one of the world's leading cancer centers on our clinical program," said Dr. Thomas Ramdahl, President and CEO of Algeta. "There is a great unmet medical need among men suffering from HRPC with skeletal metastases and the opening of this US clinical trial will be an important step in our overall clinical development of Alpharadin. As earlier announ
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SOURCE Algeta
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