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Algeta Completes Comprehensive Phase II Clinical Program With Alpharadin for Treating Bone Metastases in Patients With Advanced Prostate Cancer
Date:1/14/2009

ably favourable safety profile of Alpharadin compared to other products used in the treatment of HRPC. This major benefit of Alpharadin makes the ALSYMPCA phase III trial a very attractive option for suitable patients as they can continue to receive best standard care in addition to the study drug."

Results of phase II clinical study BC1-04

The BC1-04 study was a double-blind, randomized, dose-finding, repeat-dose study comparing three different dose levels of Alpharadin given three times with six weeks interval to HRPC patients with skeletal metastases. The drug was given by i.v. injection predominantly on an outpatient basis. The primary study objective was to investigate whether there was a dose-response relationship with respect to the proportion of patients showing a PSA response, and to investigate the six weeks' dosing schedule in order to prepare for possible combination trials with docetaxel.

The primary efficacy objective was met and this showed a dose-dependent effect across the three dose levels; 25 kBq/kg, 50 kBq/kg and 80 kBq/kg, respectively. The secondary, but important, endpoint of bone-specific alkaline phosphatase (b-ALP) also showed a significant dose-dependent effect between the lowest and the two higher dose levels, as well as confirming once more the strong bone-targeting nature of Alpharadin. ALP is a severity marker of metastatic bone disease and of prognostic importance. Again, the benign safety profile of Alpharadin was confirmed. Importantly for a drug in this clinical setting no significant bone marrow toxicity was observed in patients receiving Alpharadin, which suggests that in addition to being a product of choice for patients with bone metastases it may also have an ideal profile to be used in combination with other therapies.

Algeta began enrolling patients for the global phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study in June 2008. A
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SOURCE Algeta
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