Positive phase IIa bone marker data of Alpharadin in breast cancer patients with bone metastases presented at 2011 San Antonio Breast Cancer Symposium
(Thomson Reuters ONE) -
Oslo, Norway, 9 December 2011 - Algeta ASA (OSE: ALGETA) announces that positive
results from the phase IIa BC1-09 clinical study evaluating Alpharadin (radium-
223 chloride) in endocrine-refractory breast cancer patients with bone
metastases were presented in a poster today at the 2011 CTRC-AACR San Antonio
Breast Cancer Symposium (San Antonio, TX, USA).
These results confirm the positive preliminary results announced by Algeta and
Bayer Pharma AG in June 2011.
Analysis of the trial data found that Alpharadin treatment met the co-primary
endpoints by significantly reducing the levels of bone alkaline phosphatase
(bALP), and urine N-telopeptide (uNTX) during the 16-week treatment period in
breast cancer patients with bone metastases receiving bisphosphonates. These
parameters are used as key markers of bone involvement in breast cancer.
Median uNTX levels were reduced by 20% (from 36 to 29 nmolBCE/mmol creatinine;
p=0.0164) and by 33% (from 36 to 24 nmolBCE/mmol creatinine; p=0.0201), at weeks
8 and 16, respectively; 17/23 and 13/16 patients had a decrease in uNTX at weeks
8 and 16, respectively.
Median bALP levels were reduced by 45% (from 22.1 to 12.1 ng/mL; p=0.001) at
week 8 and by 51% (from 22.1 to 10.9 ng/mL; p=0.0045) at week 16; bALP levels
were reduced in 20/22 patients at week 8 and in 14/16 patients at week 16.
Alpharadin was also found to be safe and well-tolerated in the study, confirming
the well-tolerated side effect profile seen in other studies. Three patients
reported serious adverse events, although none of these events was deemed to be
related to the study drug.
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These results are
encouraging for patients with bone metastases in breast cancer, who do not
always respond well to current treatments. They follow the exciting positive
phase III results we have seen in prostate cancer patients with bone metastases,
suggesting that Alpharadin may have potential in treating bone metastases across
multiple cancer indications. We look forward to further trials to confirm this."
Prof. Robert Coleman, a cancer specialist at the Weston Park Hospital in
Sheffield and Principal Investigator for the trial, said: "Bone metastases cause
significant distress for patients and may respond poorly to current modalities
of treatment. We are encouraged that Alpharadin has shown efficacy against key
markers of bone disease in these breast cancer patients. If Alpharadin can show
positive results in larger trials in breast cancer, then it may become an
important new therapy for women with limited treatment options."
The poster (number P4-16-04, abstract 41.035, Coleman, et al.) was entitled "An
open-label, phase IIa, non-randomized study of radium-223 in breast cancer
patients with bone dominant disease no longer considered suitable for endocrine
therapy." The poster will be available at www.algeta.com
BC1-09 trial design
The study included metastatic breast cancer patients with bone-dominant disease
who had progressed (based on imaging or other clinically relevant information)
on endocrine therapy and were no longer considered suitable for endocrine
therapy. In this open-label, multicenter, single-arm, phase IIa study, 23
patients were scheduled to receive four intravenous injections of radium-223
chloride 50 kBq/kg every four weeks. Bone markers were assessed at baseline,
prior to every treatment, and thereafter at each follow-up visit. The co-primary
efficacy endpoints were changes from baseline in urine levels of N-telopeptide
(uNTX) and bone alkaline phosphatase (bALP) at 16 weeks. Functional imaging with
FDG-PET was performed in 20 patients at baseline and weeks 8 and 16. Symptomatic
response was assessed using validated questionnaires (data not available yet).
###
For further information, please contact
Algeta ASA:
Mike Booth +47 2202 4510
Communications & Corporate Affairs ir(at)algeta.com
International media enquiries:
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson mark.swallow(at)citigatedr.co.uk
US investor enquiries:
Jessica Lloyd +1 646 378 2928
The Trout Group jlloyd(at)troutgroup.com
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 a first-in-class,
highly targeted alpha-pharmaceutical under clinical evaluation to improve
survival in patients with advanced forms of cancer and bone metastases. Its
localized action helps preserve the surrounding healthy tissue thereby limiting
side-effects.
Alpharadin is being developed under a development and commercialization
agreement with Bayer Pharma AG. In June 2011, a global phase III clinical trial
(ALSYMPCA) of Alpharadin to treat castration-resistant prostate cancer (CRPC)
patients with symptomatic bone metastases was stopped early after meeting its
primary endpoint of significantly improving overall survival. The US Food and
Drug Administration (FDA) granted Alpharadin Fast Track designation for this
indication. Alpharadin is also in clinical development as a potential new
treatment for breast cancer patients with bone metastases, and is in a phase
I/IIa trial in combination with docetaxel chemotherapy in CRPC patients with
bone metastases.
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 frequently in certain late-stage cancers, e.g.
prostate (in up to 90% patients), breast (up to 80%) and lung (up to 40%).
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,
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 and difficulties of obtaining relevant governmental approvals for
new products, and the other risks and uncertainties described in our annual
report.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
SABCS 2011 poster:
http://hugin.info/134655/R/1570294/488254.pdf
Press release:
http://hugin.info/134655/R/1570294/488253.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#1570294]
Unternehmensinformation / Kurzprofil:
Datum: 09.12.2011 - 14:00 Uhr
Sprache: Deutsch
News-ID 95560
Anzahl Zeichen: 9755
contact information:
Town:
Oslo
Kategorie:
Business News
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"Positive phase IIa bone marker data of Alpharadin in breast cancer patients with bone metastases presented at 2011 San Antonio Breast Cancer Symposium"
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