Alpharadin found to be safe and easy to use in patients with bone metastases resulting from castration-resistant prostate cancer (CRPC)
(Thomson Reuters ONE) -
Oslo, Norway, 3 November 2010 - Algeta ASA (OSE: ALGETA), the focused oncology
company, presented yesterday an analysis based on clinical experience with
Alpharadin from its phase I and phase II programs. The analysis concluded that
Alpharadin is safe and easy to use, requires no specialized equipment and is
convenient for patients. These data were presented in a poster at the 52nd
annual meeting of the American Society for Radiation Oncology (ASTRO) in San
Diego, USA.
Alpharadin (radium-223 chloride) is a first-in-class alpha-pharmaceutical with a
potent, targeted effect on bone metastases and a highly tolerable side-effect
profile in patients with bone metastases resulting from castration-resistant
prostate cancer (CRPC).
The properties of Alpharadin were characterized to establish the radiation
protection parameters for its safe use in the phase I and phase II clinical
trials involving 292 patients, and the ongoing 900-patient phase III ALSYMPCA
study.
Key among the properties described was the ultra-short penetration of alpha
particles and the fact that alpha radiation is readily blocked, which allows for
ease of handling of Alpharadin and no requirement for complex shielding during
shipping and administration. Patients are treated as outpatients and can return
to normal life immediately afterwards.
From a clinical perspective, the major benefit of alpha-pharmaceuticals is that
the ultra-short range corresponds to a highly localized cytotoxic action in
target areas containing bone metastases (effective range: 2-10 cell diameters).
This localized effect spares surrounding healthy tissue and bone marrow and
results in the favorable side-effect profile observed in the phase II clinical
program: hematologic adverse events with Alpharadin were typically mild (CTC
grades 1, 2) and transient, and not one patient withdrew due to hematologic
toxicity.
Finally, Alpharadin is manufactured as a ready-to-use vial and the 11.4 day
half-life allows a long shelf life of 28 days, enabling sufficient time for its
distribution (including long-distance shipment) and administration to patients.
Gillies O'Bryan-Tear, Algeta's CMO, commented: "Alpha-pharmaceuticals represent
a truly new class of cancer therapeutic that produces a potent, localized
therapeutic effect combined with a highly favourable side-effect profile. Our
studies with Alpharadin have demonstrated that alpha-pharmaceuticals are easy to
use for clinicians and convenient for patients, all of which gives us great
confidence in the potential of alpha-pharmaceuticals to establish themselves in
future regimes for cancer patients in need of new treatment options."
Copies of the poster are 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/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 being developed under a development and commercialization
agreement 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 prostate cancer (CRPC). Alpharadin is also
under investigation in phase II clinical trials as a potential new treatment for
bone metastases in endocrine-refractory breast cancer patients, and in a phase
I/IIa trial in combination with docetaxel chemotherapy in for bone metastases
CRPC 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#1458295]
Press release:
http://hugin.info/134655/R/1458295/397782.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
Unternehmensinformation / Kurzprofil:
Datum: 03.11.2010 - 08:15 Uhr
Sprache: Deutsch
News-ID 48350
Anzahl Zeichen: 7940
contact information:
Town:
Oslo
Kategorie:
Business News
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"Alpharadin found to be safe and easy to use in patients with bone metastases resulting from castration-resistant prostate cancer (CRPC)"
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