Oslo, Norway, December 20th 2007 - Algeta ASA, the cancer therapeutics company, is pleased to provide an update on its clinical development of Alpharadin in hormone refractory prostate cancer (HRPC).
Phase III trial programme Algeta has finalised the study design for its pivotal international Phase III trial programme. Regulatory filing for start up of the trial is planned to commence early in 2008, and the first patient is expected to enrol before mid-2008. Initially, the trial is planned to enrol a total of 450 patients and to include clinical centres in Europe, Asia/Pacific and South America.
The primary endpoint of the Phase III trial will be the overall survival benefit of Alpharadin in patients with skeletal metastases from HRPC. The double-blind, controlled trial will enrol symptomatic HRPC patients who will be randomised to receive Alpharadin plus best supportive care or placebo plus best supportive care. Patients will receive multiple injections of Alpharadin over a period of six months.
An independent safety and monitoring board will be established to review the safety data of the trial.
Ongoing Phase I and II trial programme
Algeta's Phase II clinical development programme of Alpharadin in HRPC involves three clinical studies. The major efficacy study (BC1-02) has already been reported, and demonstrated significant survival benefit and a benign side effect profile in HRPC patients. Algeta began preparing the Phase III trial based on these encouraging data.
In the second Phase II trial (BC1-03), a potential dose-response relationship of the pain palliating effect of a single injection of Alpharadin in patients with painful skeletal metastases from HRPC is being studied. Four different dose levels of Alpharadin, ranging from 5 to 100 kBq/kg will be evaluated in this randomised, comparative, double-blind design. Patient enrolment is now complete and preliminary data from this trial is expected to be available in Q2 2008.
In the final Phase II study (BC1-04), a potential relationship between dose and therapeutic effect in patients with symptomatic or non-symptomatic HRPC, as measured by levels of serum prostate specific antigen (PSA), a widely recognized biomarker for progression of prostate cancer, is being explored. The patients in the trial have been randomised to three different dose levels of Alpharadin for a blinded evaluation. Patients will receive three injections of Alpharadin given at six-week intervals and patient recruitment is now complete. The preliminary results from this trial are expected to be available in Q3 2008.
Finally, patient enrolment in an open Phase I dosimetry trial (BC1-05) is ongoing and patient enrolment is expected to be complete during Q1 2008. This trial will provide additional biodistribution, pharmacokinetic, dosimetry and safety data for Alpharadin.
Together, these trials will provide additional clinical efficacy and safety data to supplement that provided by the highly successful Phase II efficacy trial (BC1-02).
Dr. Thomas Ramdahl, President and CEO of Algeta, said: "We have achieved two further important milestones in our Phase II trials by completing the enrolment of patients and we look forward to the first results in Q2 and Q3 in 2008. While these additional trials are important to support our overall clinical package for Alpharadin, our main focus is now on finalising preparations for the start of Phase III trials. We are well advanced in this process and have finalised the study design, which will measure the overall survival benefit of Alpharadin in HRPC patients, an unequivocal and internationally accepted endpoint for developmental prostate cancer treatments. We are on target for entering the first patient into the trial before mid-2008."