Analysis of updated ALSYMPCA phase III data confirms .


10.02.12 07:05
Meldung
 
Analysis of updated ALSYMPCA phase III data confirms overall survival benefit of Alpharadin in castration-resistant prostate cancer patients with bone metastases

Not intended for US media

Oslo, Norway, 10 February 2012 - ALGETA ASA (OSE: ALGETA) announces that the survival analysis has been completed on updated clinical data generated from the ALSYMPCA phase III trial evaluating the investigational compound Alpharadin (radium-223 chloride), which is exclusively licensed by Bayer, in patients with castration-resistant prostate cancer (CRPC) patients and bone metastases.

The updated survival analysis was performed on data from all 921 patients randomized into the pivotal phase III, randomized, placebo-controlled, multicenter study. At the recommendation of the Independent Data Monitoring Committee, the study was stopped and unblinded in June 2011.

The updated analysis (n=921) confirmed the overall efficacy results of the pre-planned interim analysis from June 2011, showing an increase in median overall survival of 3.6 months (14.9 months in the Alpharadin arm vs. 11.3 months in the placebo arm). The hazard ratio was unchanged and the p-value improved.

The regulatory submissions for approval are anticipated mid 2012.

Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "This analysis of the updated ALSYMPCA data confirms the positive results we have previously seen with Alpharadin in improving survival in CPRC patients with bone metastases. We look forward to the regulatory filings in the middle of this year."

Alpharadin 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.

###

For further information, please contact

Mike Booth

Communications & Corporate Affairs
+47 2202 4510

ir@algeta.com
International media enquiries:

Mark Swallow

Citigate Dewe Rogerson
+44 207 638 9571

mark.swallow@citigatedr.co.uk
US investor enquiries:

Jessica Lloyd

The Trout Group
+1 646 378 2928

jlloyd@troutgroup.com

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.

Algeta's lead product Alpharadin (radium-223 chloride) is in development as a potential new treatment for cancer patients with bone metastases. It is in pre-registration for castration-resistant prostate cancer (CRPC) patients with bone metastases, and filings are expected mid 2012 in the USA and Europe; Alpharadin has Fast Track designation for this indication in the USA.

Alpharadin is also under clinical investigation in breast cancer patients with bone metastases and in combination with docetaxel chemotherapy in CPRC patients with bone metastases.

Alpharadin is being developed and will be commercialized, pending approval, under a global agreement with Bayer Pharma AG.

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 is listed on the Oslo Stock Exchange (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statements

This news release contains certain forward-looking statements 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. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance to the correctness of such statements. 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 or uncertainties associated with the success of future clinical trials, collaborations with other companies in the development of targeting molecules and alpha particle payloads, risks associated with technological development, growth management, general economic and business conditions and the pricing environment, the impact of competition, the ability to successfully commercialize Alpharadin and our other products, the risk that research & development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for Alpharadin and our other products as well as the expected timing of filings for regulatory approvals, and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report.

Press release






This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.



The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the

information contained therein.



Source: Algeta ASA via Thomson Reuters ONE


HUG#1584461



 

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