Analysis of updated ALSYMPCA phase III data confirms overall survival benefit of Alpharadin in castration-resistant prostate cancer patients with bone metastases
(Thomson Reuters ONE) -
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 +47 2202 4510
Communications & Corporate Affairs ir(at)algeta.com
International media enquiries: +44 207 638 9571
Mark Swallow mark.swallow(at)citigatedr.co.uk
Citigate Dewe Rogerson
US investor enquiries: +1 646 378 2928
Jessica Lloyd jlloyd(at)troutgroup.com
The Trout Group
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:
http://hugin.info/134655/R/1584461/495715.pdf
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]
Unternehmensinformation / Kurzprofil:
Datum: 10.02.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 113231
Anzahl Zeichen: 6337
contact information:
Town:
Oslo
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 235 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Analysis of updated ALSYMPCA phase III data confirms overall survival benefit of Alpharadin in castration-resistant prostate cancer patients with bone metastases"
steht unter der journalistisch-redaktionellen Verantwortung von
Algeta ASA (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
