Clinical analyses from Alpharadin clinical program to be presented at ASCO
(Thomson Reuters ONE) -
Findings support specific targeting of Alpharadin to bone metastases and highly
tolerable safety profile
Oslo, Norway, 4 June 2010 - Algeta ASA (OSE: ALGETA), the focused oncology
company, announces that analyses of clinical data from its phase I and phase II
clinical program with Alpharadin will be presented at the 46th Annual Meeting of
the American Society for Clinical Oncology (ASCO), 4-8 June 2010 in Chicago,
USA.
Alpharadin (radium-223 chloride), being developed by Algeta and Bayer Schering
Pharma AG, is a first-in-class alpha-pharmaceutical that has demonstrated in
clinical trials a potent and highly targeted antitumor effect on bone metastases
in cancer patients combined with a highly tolerable side-effect profile.
Alpharadin is currently being evaluated in a global phase III clinical trial
(ALSYMPCA) to treat bone metastases resulting from castration-resistant
(hormone-refractory) prostate cancer (CRPC), with overall survival as the
primary endpoint.
Highlights of the analysis of the clinical data presented at ASCO are:
* A combined safety analysis from 292 patients who received Alpharadin in the
phase I and phase II studies confirmed its highly tolerable side-effect
profile. The incidence of haematological toxicity was very low and there was
no observed renal or hepatic toxicity.
* Analysis of data from a phase I pharmacokinetic and biodistribution study
with escalating doses of Alpharadin found that Alpharadin rapidly cleared
the blood and began accumulating in bone metastases within ten minutes of
injection.
* Analysis of biodistribution and dosimetry data from the phase I program
showed that Alpharadin was rapidly and specifically taken up by bone and the
remainder was rapidly excreted, predominantly through the gastrointestinal
tract.
* The rapid localization of Alpharadin to bone metastases combined with its
emission of very short-range and potent alpha radiation may account for the
highly tolerable safety profile observed in phase I and II studies.
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said, "It is rare to see
such a favorable safety profile in a new oncology candidate. The tolerability of
Alpharadin combined with the evidence from a phase II that it can confer a
significant survival benefit and improve patients' quality of life continues to
give us great confidence in Alpharadin's potential to address the devastating
impact of bone metastases in cancer patients."
Copies of the posters will available from www.algeta.com
###
For further information, please contact:
For Algeta:
Andrew Kay, CEO +47 2300 7990 / +47 4840 1360 (mob)
Gillies O'Bryan-Tear, CMO +47 23 00 7824 / +47 4804 1411 (mob)
Øystein Soug, CFO +47 2300 7990 / +47 9065 6525 (mob)
post(at)algeta.com
International media enquiries: +44 207 638 9571
Mark Swallow/Helena Galilee/David Dible 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
For Bayer Schering Pharma:
David Freundel +1 (973) 305-5310
david.freundel(at)bayer.com
About Algeta
Algeta is a focused oncology company developing novel targeted therapies for
patients with cancer based on its alpha-pharmaceutical platform.
Algeta's lead product Alpharadin (based on radium-223) 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 in up to 90% of certain late-stage cancers, e.g.
prostate, breast and lung.
Alpharadin is partnered with Bayer Schering Pharma AG, a major pharmaceutical
company, and is in a global phase III clinical trial (ALSYMPCA) to treat bone
metastases resulting from hormone-refractory (castration-resistant) prostate
cancer. Alpharadin is also under investigation in phase II clinical trials as a
potential new treatment for bone metastases in endocrine-refractory breast
cancer patients.
Algeta also aims to develop a future pipeline of tumor-targeting
alpha-pharmaceutical candidates based on the alpha particle emitter thorium-227,
through selective in-licensing and/or acquiring innovative technologies and
tumor-targeting molecules.
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 trademarks of Algeta ASA.
Forward-looking Statement
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. Theses
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.
###
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1421556]
Press release: http://hugin.info/134655/R/1421556/370852.pdf
Unternehmensinformation / Kurzprofil:
Datum: 04.06.2010 - 09:02 Uhr
Sprache: Deutsch
News-ID 21963
Anzahl Zeichen: 0
contact information:
Town:
Oslo
Kategorie:
Business News
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