Updated phase III data confirm overall survival benefit of Alpharadin in men with advanced prostate cancer that has spread to the bone
(Thomson Reuters ONE) -
Not intended for US media
* Overall survival in Alpharadin arm significantly increased by 44%
* Median survival benefit increased to 3.6 months
* Significantly delayed time to first skeletal-related event (SRE)
* Submissions seeking marketing approval in US & Europe expected in 2H 2012
* Further development activities to include combination trials in prostate
cancer, as well as studies in breast cancer and osteosarcoma
Oslo, Norway, 4 June 2012 - Algeta ASA (OSE: ALGETA) announces that updated data
from the pivotal phase III ALSYMPCA trial for its investigational drug
Alpharadin (radium-223 dichloride[1]) confirm the improvement in overall
survival of Alpharadin in men with castration-resistant prostate cancer (CRPC)
and symptomatic bone metastases, compared to the interim analysis from June
2011.
The updated data showed that Alpharadin improved overall survival by 44%
(p=0.00007, HR=0.695), resulting in a 30.5% reduction in the risk of death
compared to placebo. The median overall survival benefit with Alpharadin was
2.8 months at the time of the interim analysis in June 2011 and 3.6 months in
this updated analysis (14.9 months in patients given Alpharadin vs. 11.3 months
with placebo). These data will be presented as a late-breaking abstract in an
oral abstract session on June 5, 2012 at the 48th Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago, IL (USA) (LBA No. 4512).
"Bone metastases are one of the main causes of disability and death in patients
with castration-resistant prostate cancer, yet until now there has been little
progress made towards developing therapies that target the cancer when it has
spread to the bone," said Dr. Chris Parker of The Royal Marsden NHS Foundation
Trust, London, and The Institute of Cancer Research, London, and principal
investigator of ALSYMPCA. "Alpharadin is the first therapy specifically
addressing cancer that has spread to the bone that has shown, in a phase III
trial, to significantly improve overall survival."
In addition to improving overall survival, radium-223 dichloride led to a
statistically significant delay in the time to first skeletal-related event
(SRE).
The overall safety and tolerability profile for Alpharadin was consistent with
previous study results. The most common hematologic adverse events included
anemia (31% vs. 31%), neutropenia (5% vs 1%) and thrombocytopenia (12% vs. 6%)
for patients receiving Alpharadin compared to placebo. With respect to Grade 3
and 4 adverse events, the most common events included anemia (13% vs. 13%),
neutropenia (2% vs. 1%) and thrombocytopenia (6% vs. 2%). The most common non-
hematologic adverse events included bone pain (50% vs. 62%), nausea (36% vs.
35%), diarrhea (25% vs. 15%), and vomiting (19% vs. 14%) for patients receiving
Alpharadin as compared to placebo. With respect of Grade 3 to 4 adverse events,
the most common events included bone pain (21% vs. 26%).
Andrew Kay, President & CEO of Algeta, commented: "The results from the
extensive clinical program evaluating Alpharadin continue to give us confidence
in its potential, pending marketing approvals, to become a new treatment option
for cancer patients with bone metastases. This is a significant achievement for
Algeta. In turn, this provides a strong foundation on which we are building a
global oncology company with a high quality commercial organization in the US
allied to our research and development headquarters in Norway."
Alpharadin has been granted Fast Track designation by the US Food & Drug
Administration (FDA). The Fast Track process is designed to facilitate the
development, and expedite the review, of drugs to treat serious diseases and
fill an unmet medical need. Fast Track designation must be requested by the drug
company and can be initiated at any time during the drug development process.
Bayer plans to file Alpharadin seeking marketing approval for CRPC with
regulatory authorities in the US and Europe based on the ALSYMPCA data in the
second half of 2012. In terms of further development activities, Bayer intends
to conduct studies in earlier settings of prostate cancer, including combination
studies with other agents, as well as undertaking exploratory studies in other
tumors such as breast cancer and osteosarcoma.
The presentation slides given by Dr Parker will be made available to download at
www.algeta.com following the session.
###
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 dichloride) is being evaluated as a
potential new treatment for cancer patients with bone metastases. Alpharadin is
under clinical investigation in castration-resistant prostate cancer (CRPC)
patients with bone metastases. Submissions seeking marketing approval for this
indication are expected to be made in the second half of 2012 to regulatory
authorities in both the US and Europe; Alpharadin has Fast Track designation for
this indication in the US. Alpharadin, which is exclusively licensed to Bayer,
is not currently approved by the US Food & Drug Administration (FDA), the
European Medicines Agency (EMA) or any other health authority.
Alpharadin is also under clinical investigation in endocrine-refractory breast
cancer patients with bone metastases and is in a phase I/IIa trial in
combination with docetaxel chemotherapy in CPRC patients with bone metastases.
Alpharadin is being evaluated and will be commercialized, if approved, under a
global agreement with Bayer Pharma AG. If approved, Bayer will market Alpharadin
worldwide, and Algeta will co-promote Alpharadin with Bayer in the US.
Algeta is also evaluating 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 potential future pipeline of tumor-targeting alpha-
pharmaceutical candidates. Algeta has TTC agreements in place with Sanofi and
Affibody.
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 that relate to
events and depend on circumstances that will occur in the future which, by their
nature, may 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 as to whether such forward looking statements will prove to be
correct. These forward looking statements include statements regarding expected
timing of regulatory filings and future development activities. 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, unforeseen delays in the timing of
expected regulatory filings, 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, the ability to
identify and hire a sufficient number of qualified employees for the US field
force, 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 costs associated
with the co-promotion of Alpharadin may be greater than anticipated, 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 and difficulties of obtaining relevant governmental approvals for new
products, and the other risks and uncertainties described in our annual report.
[1] Previously referred to as radium-223 chloride.
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Pres release:
http://hugin.info/134655/R/1616967/515818.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#1616967]
Unternehmensinformation / Kurzprofil:
Datum: 04.06.2012 - 06:02 Uhr
Sprache: Deutsch
News-ID 152472
Anzahl Zeichen: 10608
contact information:
Town:
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Kategorie:
Business News
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"Updated phase III data confirm overall survival benefit of Alpharadin in men with advanced prostate cancer that has spread to the bone"
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