Algeta completes successful sample size re-estimation of pivotal ALSYMPCA trial
(Thomson Reuters ONE) -
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.
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
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 castration-resistant (hormone-refractory) 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#1410959]
Press release: http://hugin.info/134655/R/1410959/363311.pdf
Unternehmensinformation / Kurzprofil:
Datum: 03.05.2010 - 07:53 Uhr
Sprache: Deutsch
News-ID 20116
Anzahl Zeichen: 0
contact information:
Town:
Oslo
Kategorie:
Business News
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