OSLO, Norway, June 6, 2011 /PRNewswire/ --
- Trial Stopped Based on Data Results from Pre-Planned Interim Analysis; Patients in Placebo Arm Will Be Offered Treatment with Radium-223 Chloride
Algeta ASA (OSE: ALGETA) today announced that the Phase III ALSYMPCA (radium-223 chloride in SYMptomatic Prostate CAncer) trial evaluating the investigational compound radium-223 chloride, which is exclusively licensed by Bayer, in patients with castration-resistant prostate cancer (CRPC) and bone metastases met its primary endpoint by significantly improving overall survival. Based on a recommendation from the Independent Data Monitoring Committee (IDMC), following a pre-planned interim analysis, the study will be stopped and patients on the placebo arm will be offered treatment with radium-223 chloride. The overall survival result was statistically significant (two-sided p-value =0.0022, HR = 0.699, the median overall survival was 14.0 months for radium-223 chloride and 11.2 months for placebo). The complete results from the study will be presented at an upcoming scientific meeting.
The safety and tolerability of radium-223 chloride were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in the safety profile of radium-223 chloride. Common adverse events from the ALSYMPCA trial included diarrhea, neutropenia and thrombocytopenia
Radium-223 chloride is an investigational agent and is not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other health authorities.
"We are pleased that radium-223 met its primary endpoint of significantly improving overall survival in patients with CRPC and bone metastases, and are hopeful about the potential of radium-223 chloride for this patient population," said Andrew Kay, President and CEO of Algeta.
The filing strategy for radium-223 chloride based on the IDMC's recommendation to stop this study, is being evaluated and patients in the placebo arm will be offered treatment with radium-223 chloride.
Phase III Trial Design
The ALSYMPCA trial is a Phase III, randomized (2:1), double-blind, multi-dose, placebo-controlled international study of radium-223 plus current standard of care compared with placebo plus current standard of care in patients with symptomatic castration-resistant/hormone-refractory prostate cancer that has spread to the bone. The primary endpoint of the study is overall survival. Secondary endpoints include time to occurrence of skeletal related events (SRE), changes and time to progression in prostate-specific antigen (PSA) tests and alkaline phosphatase (ALP) tests, safety and impact on quality of life and health economics. ALSYMPCA was initiated by Algeta ASA (Oslo, Norway) in June 2008. Enrollment in the trial was completed in January 2011 and 922 patients were randomized.
About Radium-223 Chloride
Radium-223 chloride is an investigational pharmaceutical containing an alpha-particle emitting nuclide in development for cancer patients with bone metastases. In September 2009, Bayer signed an agreement with Algeta for the development and commercialization of radium-223 chloride. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally, while Algeta retains an option for up to 50/50 co-promotion and profit-sharing in the United States.
About CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in Northern European countries and the United States. In 2008, an estimated 903,000 men had prostate cancer and 250,000 died from the disease worldwide.
Castration-resistant prostate cancer (CRPC) was formerly known as hormone-refractory prostate cancer (HRPC). Approximately 90 percent of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to bone pain, fracture and other complications that can significantly impair a man's health. In fact, bone metastases are the main cause of disability and death in patients with CRPC.
Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.
Radium-223 chloride is being developed under a development and commercialization agreement with Bayer Schering Pharma AG, and is in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-resistant prostate cancer (CRPC). Radium-223 chloride is also under investigation in phase IIa clinical trials as a potential new treatment for bone metastases in endocrine-refractory breast cancer patients, and in a phase I/IIa trial in combination with docetaxel chemotherapy in for bone metastases CRPC patients.
Algeta is also exploring the potential of Targeted Thorium Conjugates (TTCs), which are based on conjugating the alpha-emitter thorium-227 to targeting molecules, as a basis of a future pipeline of tumor-targeting alpha-pharmaceutical candidates.
The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.