Algeta is a Norwegian company that a few might have seen mentioned after they announced a deal with Bayer for Alpharadin.
September 3, 2009, Bayer to Pay Up to $800 Million for Algeta’s New Drug
more recent news.
Algeta completes successful sample size re-estimation of pivotal ALSYMPCA trial
Current study on schedule; opportunity taken to boost patient numbers without impacting time to filing
Oslo, Norway, 3 May 2010 - Algeta ASA (OSE: ALGETA), the focused oncology company, is pleased to announce that the sample size re-estimation of its pivotal ALSYMPCA clinical trial, which was pre-planned for the first half of 2010, was completed on schedule.
The sample size re-estimation confirmed that the current plan to recruit 750 patients into the ALSYMPCA study will meet the goals originally set for the study.
Algeta and its partner Bayer Schering Pharma AG ("Bayer") have in parallel decided to increase recruitment for ALSYMPCA to 900 patients. This will increase the statistical power of the trial to 90% thereby further increasing the likelihood of proving the efficacy of Alpharadin. It will also allow the study to recruit US patients, and allow US clinical oncologists to gain experience with the use of Alpharadin. Recruitment in ALSYMPCA passed 600 patients during April.
Importantly, based on the rapid recruitment already seen in this pivotal study, Algeta and Bayer anticipate the enrolment of ALSYMPCA will still complete as planned in the second half of 2010 with results of the trial anticipated in 2012. This would allow for a filing in 2012 as planned.
Andrew Kay, Algeta's President & CEO, said: "We are very pleased with the outcome of the sample size re-estimation as it confirms ALSYMPCA is a robust and well-designed trial. The trial recruitment rate is currently very good, and is expected to be boosted over the next few months as world-leading cancer centers in the USA come on-stream. This leads us to believe that the additional 150 patients can be enrolled in only a few months enabling us to complete recruitment in the second half of 2010."
Notes to Editors
A sample size re-estimation/confirmation used in major pivotal trials is a pre-planned checkpoint, and agreed with the regulators in the ALSYMPCA trial protocol. The purpose of the analysis was to check that sufficient events (deaths) will occur in the study within the required time period to detect the anticipated effect (overall survival benefit) of Alpharadin in these patients - i.e. to ensure the study has sufficient power.
The protocol amendment describing the increase in number of patients will be submitted to regulatory authorities before implementation.
ALSYMPCA (ALpharadin in SYMptomatic Prostate Cancer Patients) is a global phase III clinical trial evaluating the potential of Alpharadin (radium-223 chloride) to treat bone metastases resulting from castration-resistant (hormone-refractory) prostate cancer (CRPC). Bone metastases are the main cause of disability and death in patients with CRPC and approximately 90% of men with this disease have radiological evidence of bone metastasis. Alpharadin is being developed by Algeta and Bayer Schering Pharma AG and is a first-in-class alpha-pharmaceutical that has a potent and highly targeted antitumor effect on bone metastases combined with a highly favorable side-effect profile. In phase II trials, Alpharadin showed a statistically significant improvement in overall survival compared to placebo.
Algeta schedules First Quarter 2010 Presentation
Oslo, Norway, 3 May 2010 - Algeta ASA (OSE: ALGETA), the focused oncology company, will announce its first quarter 2010 results on Friday, 7 May 2010. A presentation to investors, analysts and the press will take place in Oslo at 09:45 CET. Algeta's President and CEO Andrew Kay and CFO Øystein Soug will present.
The presentation will also be webcast live and can be accessed from www.algeta.com/webcast where questions can be submitted live during the presentation.
#27) On September 08, 2009 at 5:09 AM, portefeuille (99.97) wrote: ALGETA.OL - 9.97 (59.25 NOK) - outperform