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Algeta: New analyses from phase III ALSYMPCA trial in patients with castration-resistant prostate cancer with bone metastases presented at ESMO 2012


October 1, 2012 - London

Not intended for US media
  

  • Radium-223 dichloride (Alpharadin) was significantly superior to placebo in health-related quality of life (QOL) measures  

  • Hematologic safety profiles for patients receiving chemotherapy after radium-223 dichloride were similar to those receiving chemotherapy after placebo  

Oslo, Norway, 1 October 2012 - Algeta ASA (OSE: ALGETA) announces that further data and analysis from the phase III ALSYMPCA study of radium-223 dichloride (Alpharadin) in patients with castration-resistant prostate cancer with bone metastases have been presented as two posters at the ESMO 2012 Congress (Vienna, Austria; 28 September - 2 October 2012).

Dr. Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These new analyses continue to build our confidence in radium-223 dichloride's potential for use in the treatment of castration-resistant prostate cancer patients with bone metastases."

Both posters can be found at www.algeta.com

Safety of chemotherapy after radium-223 dichloride (Poster 936P)

The first analysis, conducted post-hoc and presented by Dr. Oliver Sartor (Medical Director Tulane Cancer Center, Tulane Medical School, New Orleans, LA, and Principal Investigator for US arm of ALSYMPCA), found that, based on the limited sample size (n=147), hematologic safety profiles for patients receiving chemotherapy after radium-223 dichloride were similar to those for patients receiving chemotherapy after placebo.

The cohort for this analysis consisted of all patients who received chemotherapy after administration of radium-223 dichloride or placebo. The proportion of patients receiving subsequent chemotherapy was 93/614 (15%) in the radium-223 dichloride group and 54/307 (18%) in the placebo group. The most common chemotherapeutic agents administered after study drug treatment were docetaxel (n=105), mitoxantrone (n=23), and cyclophosphamide (n=19).

Administering chemotherapy after the study drug had no deleterious effect on patient overall survival (OS). In the 147 patients from the ALSYMPCA study receiving chemotherapy after study drug, median OS from start of chemotherapy was 15.6 months in the radium-223 dichloride group and 14.6 months in the placebo group (P = 0.663).

Quality of Life assessment (Poster 898PD)

The second, preplanned, analysis, from all 921 patients recruited into ALSYMPCA and presented by Dr. Christopher Parker (Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK, and Principal Investigator for ALSYMPCA), concluded that radium-223 dichloride showed significantly better preservation of quality of life (QOL), with improved functioning and well-being, compared to placebo, as well as confirming previously reported survival and safety endpoints.

Radium-223 dichloride improved the QOL response rate versus placebo (27% vs 18% p < 0.05), and better preserved QOL over time versus placebo (FACT-P: p < 0.05). QOL was assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EuroQoL (EQ-5D) instruments, both well validated instruments in prostate cancer.

Radium-223 dichloride is not currently approved by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other health authority.

References

936P - Sartor, O. et al. Safety of cytotoxic chemotherapy following radium-223 chloride (Ra-223) therapy in the phase 3 ALSYMPCA study in patients with castration-resistant prostate cancer (CRPC) with bone metastases.

898PD - Parker, C. et al. Updated survival, quality of life (QOL), and safety data of radium-223 chloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) with bone metastases from the phase 3 double-blind, randomized, multinational study (ALSYMPCA).

###

For further information, please contact

Mike Booth +47 2202 4510
Communications & Corporate Affairs ir@algeta.com
International media enquiries:
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk
US investor enquiries:
Tricia Swanson +1 646 378-2953
The Trout Group tswanson@troutgroup.com

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. The Company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA performing commercial marketing operations in the US. Algeta is listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information please visit www.algeta.com.

Forward-looking statements

This news release contains certain forward-looking statements that are based on uncertainty, as they relate to events and depend on circumstances that will occur in the future and which, by their nature, may have an impact on results of operations and the financial condition of Algeta. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking statements will prove to be correct. These forward looking statements include future development activities.  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, unforeseen delays in the timing of expected regulatory filings, general economic and business conditions, the ability to successfully commercialize radium-223 dichloride risks in obtaining regulatory approvals for radium-223 dichloride, and the other risks and uncertainties described in our annual report.

This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Press release



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Source: Algeta ASA via Thomson Reuters ONE

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