Positive Outcome of Interim Analysis of pivotal Alpharadin study: Primary endpoint met in Phase III ALSYMPCA study.
Alpharadin is in development for treating bone metastases in patients with castration-resistant prostate cancer.
Oslo, Norway, 6 June 2011 – Algeta ASA (OSE: ALGETA) today announced that an independent expert committee has recommended stopping its phase III,pivotal, ALSYMPCA study of Alpharadin (radium-223 chloride) for the treatment of bone metastases in patients with castration-resistant prostate cancer (CRPC) on the basis of statistically significant efficacy.
Based on a recommendation from the ALSYMPCA 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 Alpharadin. 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 Alpharadin and 11.2 months for placebo). The complete results from the study will be presented at an upcoming scientific meeting and submitted for publication in a peer-reviewed journal.
The safety and tolerability of Alpharadin 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 Alpharadin.
Alpharadin is being developed by Algeta and Bayer Schering Pharma AG (“Bayer”). Under the terms of the collaboration Bayer will be responsible for the global filing. Bayer plans to discuss with the regulatory authorities in the near future regarding the filing strategy for Alpharadin, based on the IDMC’s positive recommendation to unblind this study and will offer patients in the placebo arm treatment with Alpharadin when the trial is unblinded.
The ALSYMPCA study (ALpharadin in SYMptomatic Prostate CAncer patients) is an international, double-blind, randomized, placebo-controlled phase III clinical trial evaluating the potential of Alpharadin plus best standard of care versus placebo plus best standard of care to treat symptomatic bone metastases in CRPC patients. The trial began in June 2008, enrollment in the trial was completed in January 2011 and 922 patients were randomized.
Dr Chris Parker, from the Royal Marsden Hospital, and Principal Investigator of ALSYMPCA, said:
”Around 90% of men with advanced prostate cancer have bone metastases, which are the main cause of disability and death in this disease. Advanced prostate cancer has a poor prognosis, and treatment options are limited. Based on the observed survival benefit and its safety profile, Alpharadin may become an important treatment for patients with bone metastases from advanced prostate cancer”
Andrew Kay, Algeta’s President and CEO, said:
“The positive outcome of the ALSYMPCA interim analysis is a tremendous result for Algeta, its shareholders and most importantly for the patients with CRPC who have bone metastases, which is an area of high medical need where there are few treatment options. Alpharadin, potentially the first alphapharmaceutical, demonstrated a survival benefit in this trial for patients with bone metastases and this is an exciting time for the company. We would like to thank all the investigators and patients who contributed to this clinical trial.”
Alpharadin is an investigational agent and is not approved for marketing by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), or any other health authorities.
For further information, please contact
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Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.
Alpharadin 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). Alpharadin 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 for bone metastases in CRPC patients.
Algeta’s lead product Alpharadin (based on radium-223 chloride) is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastases from advanced cancer. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects.
The development of bone metastases represents a serious development for cancer patients as they are associated with a dramatic decline in patient health and quality of life, ultimately leading to death. Bone metastases represent a major unmet medical need, occurring frequently in certain late-stage cancers, e.g. prostate (in approximately 75-90% patients), breast (up to 75 %) and lung (up to 40%). 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).
Alpharadin and Algeta are registered trademarks.
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.