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Clinical Analyses from Alpharadin Clinical Program Presented at ASCO


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Algeta ASA announces that analyzes of clinical data from its phase I and phase II clinical program with Alpharadin will be presented at the 46th Annual Meeting of the American Society for Clinical Oncology (ASCO), 4-8 June 2010 in Chicago, USA.

Alpharadin (radium-223 chloride), being developed by Algeta and Bayer Schering Pharma AG, is a first-in-class alpha-pharmaceutical that has demonstrated in clinical trials a potent and highly targeted antitumor effect on bone metastases in cancer patients combined with a highly tolerable side-effect profile.

Alpharadin is currently being evaluated in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-resistant (hormone-refractory) prostate cancer (CRPC), with overall survival as the primary endpoint.

Highlights of the analysis of the clinical data presented at ASCO are:

• A combined safety analysis from 292 patients who received Alpharadin in the phase I and phase II studies confirmed its highly tolerable side-effect profile. The incidence of haematological toxicity was very low and there was no observed renal or hepatic toxicity.

• Analysis of data from a phase I pharmacokinetic and biodistribution study with escalating doses of Alpharadin found that Alpharadin rapidly cleared the blood and began accumulating in bone metastases within ten minutes of injection.

• Analysis of biodistribution and dosimetry data from the phase I program showed that Alpharadin was rapidly and specifically taken up by bone and the remainder was rapidly excreted, predominantly through the gastrointestinal tract.

• The rapid localization of Alpharadin to bone metastases combined with its emission of very short-range and potent alpha radiation may account for the highly tolerable safety profile observed in phase I and II studies.

Gillies O’Bryan-Tear, Algeta’s Chief Medical Officer, said, “It is rare to see such a favorable safety profile in a new oncology candidate. The tolerability of Alpharadin combined with the evidence from a  phase II  that it can confer a significant survival benefit and improve patients’ quality of life continues to give us great confidence in Alpharadin’s potential to address the devastating impact of bone metastases in cancer patients.”
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