Algeta ASA today announced that the primary objective of its BC1-03 Phase II pain palliation study was met. The study showed that even single doses of Alpharadin in patients with painful bone metastases could produce increasing clinical benefit with increasing dose.
Pain palliation is an important quality of life benefit in metastatic cancer patients. The trial also confirmed Alpharadin's benign side-effect profile and, importantly for a drug in this clinical setting, no significant bone marrow toxicity was observed.
In men with HRPC life expectancy can be as short as 18 months, and it is estimated that 100,000 men in the EU and USA die from the disease each year. In 85% of these men the tumor will have spread into the bones. These metastases are a significant problem as they can cause intractable and debilitating pain as well as contributing to a further reduction in life expectancy.
The BC1-03 study was a double-blind randomised pain control study comparing the palliative effects of four different single dose levels of Alpharadin in patients with bony metastatic HRPC. The drug was given by i.v. injection mainly on an outpatient basis. The palliative efficacy of Alpharadin was measured using an assessment of bone pain as well as the patient's consumption of analgesia. The primary study objective was to investigate whether there was a dose-response relationship with respect to pain palliation in this patient group. The study has shown the beneficial palliative effect of a single dose of Alpharadin and that there is a clear dose-response effect, with higher doses providing better pain relief.
The study also showed a dose-dependent reduction in bone alkaline phosphatase (ALP) ranging from no effect in the lowest dose group to a marked reduction in the higher dose groups. ALP is a severity marker of bony metastatic disease and of prognostic importance.
The study has also further confirmed the safety of Alpharadin and shown its benign side-effect profile. In fact, the higher the dose of Alpharadin that patients received, the fewer adverse events were experienced. This reproduces the safety profile of the earlier BC1-02 Phase II study where the Alpharadin group experienced fewer adverse effects than the placebo comparator group. Importantly for a drug in this clinical setting no significant bone marrow toxicity was observed in patients receiving Alpharadin.
The full results of the BC1-03 study will be submitted for publication in a peer-reviewed journal.
The principal investigator of the study Professor Sten Nilsson at the Karolinska Hospital in Stockholm said: "These results showing the beneficial impact of Alpharadin in terms of pain palliation are important, as improved quality of life, alongside increased survival, are the two key goals of anti-cancer therapy of patients with skeletal metastases."
Commenting on today's further positive news with Alpharadin, Algeta's President and CEO, Dr. Thomas Ramdahl, said: "These results build on the positive Phase II clinical data package that we have already assembled with Alpharadin, the highlight of which was the significant survival benefits that we have already reported in patients with HRPC.
Based on our clinical trials to-date I am very confident that Alpharadin has the potential to become an important new therapy for patients with prostate cancer. This view has been reinforced by the enthusiastic and positive response we have received from key opinion leaders around the world to our unique approach to treating HRPC."
Algeta has recently started enrolling patients for the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study. This international study will evaluate Algeta's targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. Approximately 750 patients are expected to be enrolled at more than 125 medical centers in Europe, Asia, South America and Canada. The Coordinating Investigator for the study is Dr. Christopher Parker, a leading clinical oncologist and specialist in prostate cancer, based at the Institute of Cancer Research and the Royal Marsden Hospital in the UK.