Alpharadin Significantly Improves Overall Survival for Patients with Castration-Resistant Prostate Cancer and Symptomatic Bone Metastases
(Thomson Reuters ONE) -
Not intended for U.S. Media
First presentation of full ALSYMPCA phase III data as part of Presidential
Session featuring Best and Late-Breaking Abstracts at 2011 European
Multidisciplinary Cancer Congress
Oslo, Norway, 24 September 2011 - Algeta ASA is pleased to announce results
from the phase III ALSYMPCA study with the investigational agent Alpharadin
(radium-223 chloride). The study met its primary endpoint by significantly
improving survival by 44% [hazard ratio (HR)=0.695; p=0.00185] in patients with
castration-resistant (hormone-refractory) prostate cancer and symptomatic
(painful) bone metastases. All of the main secondary endpoints were met. The
ALSYMPCA study accrued 922 patients
The results of this international, double-blind, randomized, placebo-controlled
phase III clinical trial will be presented today at 14:35 CEST during the
Presidential Session I: Best and Late-Breaking Abstracts at 2011 European
Multidisciplinary Cancer Congress (EMCC) in Stockholm, Sweden (Abstract
No.1LBA). The 2011 European Multidisciplinary Cancer Congress is the 16th
congress of the European CanCer Organisation (ECCO), the 36th congress of the
European Society for Medical Oncology (ESMO) and the 30th congress of European
Society for Therapeutic Radiology and Oncology (ESTRO).
The presenter is Dr. Chris Parker from the Institute of Cancer Research (ICR)
and Royal Marsden Hospital, the principal investigator of ALSYMPCA.
The phase III data showed that patients treated with Alpharadin had the
following outcome:
* A median overall survival of 14 months compared to 11.2 months for the
placebo group,
* Median time to first skeletal-related event (SRE) of 13.6 vs. 8.4 months
(64% improvement, HR=0.610, p=0.00046),
* Total alkaline phosphatase (ALP) normalization in 32.9% of patients taking
Alpharadin vs. 0.9% of patients on placebo (p<0.001); and
* A 49% improvement in time to prostate-specific antigen (PSA) progression
(HR=0.671, p=0.00015).
* Total ALP response, defined as a 30% reduction from baseline, was seen in
43% of patients treated with Alpharadin vs. 3% in patients in the placebo
group (p<0.0001).
Alpharadin's safety profile was consistent with results from the phase I and II
studies; the most common adverse events were nausea (34% on Alpharadin and 32%
on placebo), diarrhea (22% and 13%, respectively), constipation (18% and 18%,
respectively) and vomiting (17% and 13%, respectively). The incidence of grade
3 or 4 neutropenia was 2% on Alpharadin and 1% on placebo. Bone pain was less
common on Alpharadin (43% vs. and 58% on placebo) and the overall incidence of
adverse events and serious adverse events was lower with Alpharadin than
placebo, consistent with results from phase II studies. This safety profile
shows that Alpharadin has a highly favorable therapeutic ratio when used to
treat patients with bone metastases and CRPC.
"These data are significant because they demonstrate that Alpharadin can prolong
life in patients with castration-resistant prostate cancer (CRPC) and bone
metastases" said Dr. Chris Parker of the ICR and Royal Marsden Hospital, London,
and principal investigator of ALSYMPCA. "These results and previous study
findings suggest that Alpharadin, a novel alpha-pharmaceutical, may provide a
new standard of care for the treatment of castration-resistant prostate cancer
patients with bone metastases."
Algeta's worldwide development and commercial partner, Bayer Pharma AG (Bayer),
plans to file marketing applications for Alpharadin with regulatory authorities
in the U.S. and Europe based on these data in mid-2012. If approved, Alpharadin
will be commercialized and distributed globally by Bayer. Under the terms of the
September 2009 agreement between Algeta and Bayer, Algeta has an option for up
to 50/50 co-promotion and profit-sharing in the USA.
Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "The positive
outcome of the ALSYMPCA study is a tremendous result for Algeta and Bayer, their
shareholders and most importantly for the patients with CRPC who have bone
metastases, an area of high medical need where there are few treatment options.
Alpharadin, an alpha-pharmaceutical, demonstrated a survival benefit in this
trial for patients with bone metastases and prostate cancer, making this an
exciting time for Algeta. We would like to thank all the investigators and
patients who contributed to this clinical trial."
Algeta and Bayer announced on 6 June 2011 that the Independent Data Monitoring
Committee (IDMC) recommended stopping and unblinding the ALSYMPCA phase III
study following a pre-planned interim analysis that demonstrated the trial had
met its primary endpoint by significantly improving overall survival. The safety
and tolerability of Alpharadin were also found to be consistent with previous
phase I and phase II trial outcomes and did not show any new or unexpected
changes in the safety profile of Alpharadin. The IDMC also recommended that
patients in the placebo arm be offered treatment with Alpharadin following the
unblinding of the trial.
Alpharadin was recently granted Fast Track designation by the U.S. 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.
ALSYMPCA Study Design
The ALSYMPCA trial (ALpharadin in SYMptomatic Prostate CAncer patients) is an
international, double-blind, randomized (2:1), placebo-controlled phase III
clinical study evaluating Alpharadin plus best standard of care compared with
placebo plus best standard of care in patients with CRPC and symptomatic
(painful) bone metastases. The study treatment consisted of up to six
intravenous administrations of Alpharadin or placebo, each separated by an
interval of four weeks. The study recruited 922 patients who were docetaxel
ineligible or intolerable or had failed prior docetaxel therapy at 138 centers
in 19 countries.
The primary endpoint of the study is overall survival. Secondary endpoints
include time to occurrence of SREs, changes and time to progression in PSA and
ALP, safety, and impact on quality of life measures.
About Alpharadin
Alpharadin (radium-223 chloride) is an investigational alpha-pharmaceutical (a
pharmaceutical containing an alpha-particle emitting nuclide) in development for
treating cancer patients with bone metastases. The compound mimics many of the
behaviors of calcium in the bone to target areas of high bone turnover in and
around bone metastases.
In September 2009, Algeta signed an agreement with Bayer for the development and
commercialization of Alpharadin. Under the terms of the agreement, Bayer will
develop, apply for global health authority approvals, and commercialize
Alpharadin globally, while Algeta retains an option for up to 50/50 co-promotion
and profit-sharing in the USA.
Alpharadin was granted Fast Track designation by the U.S. Food and Drug
Administration (FDA) in August 2011. Alpharadin is an investigational agent and
is not approved for marketing by the European Medicines Agency (EMA), the U.S.
FDA, or any other health authorities.
About CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in developed countries
including the United Kingdom and the United States (other than skin cancer), and
the incidence rate continues to rise. In 2008, an estimated 899,000 men were
diagnosed with prostate cancer and 258,000 died from the disease worldwide.
Prostate cancer is the sixth leading cause of death from cancer in men.
CRPC is also known as hormone-refractory prostate cancer (HRPC). The majority of
men with CRPC have radiological evidence of bone metastases. Once the cancer
cells settle in the bone, they interfere with bone strength, often leading to
bone pain, fracture and other complications that can significantly impair a
man's health. Bone metastases secondary to prostate cancer typically target the
lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause
of disability and death in patients with CRPC.
Notice of Presentation, Webcast and Conference Call
A presentation to investors and analysts will take place in Stockholm on Monday
26 September at 15:00 CEST. Algeta's President and CEO Andrew Kay and CMO
Gillies O'Bryan-Tear will present at:
HealthCap
Odlander, Fredrikson & Co AB
Strandvägen 5B
SE-114 51 Stockholm
Sweden.
The presentation will also be webcast live and can be accessed from
www.algeta.com/webcast where questions can be submitted live during the
presentation.
A conference call will be held simultaneously. To participate in the conference
call, please dial the appropriate number below five minutes prior to the call:
800 80 119 (in Norway)
+47 23 18 45 01 (from abroad)
To access the replay, please dial +47 23 18 45 02. Enter account no. 1870
followed by #, then press 1, conference no. 870 followed by #. Press 1 to play.
A replay version of the conference call will also be available at
www.algeta.com.
###
For further information, please contact:
+47 2300 7990 / +47 4840 1360 (mob)
Andrew Kay, CEO
+47 2300 7990 / +47 4840 1411 (mob)
Gillies O'Bryan-Tear, CMO
+47 2300 7990 / +47 9065 6525 (mob)
Øystein Soug, CFO
post(at)algeta.com
International media enquiries:
Mark Swallow/David Dible/Sita Shah +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.
Alpharadin is being developed under a development and commercialization
agreement with Bayer Pharma AG, 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 IIa 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 for bone metastases in CRPC patients.
Algeta's lead product Alpharadin (based on radium-223 chloride) 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 frequently in certain late-stage cancers, e.g.
prostate (in approximately 75-90% patients), breast (up to 75%) 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 was founded in 1997. Algeta
listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).
Alpharadin and Algeta are registered trademarks.
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. These
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 pursuant to section
5-12 of the Norwegian Securities Trading Act.
Press release:
http://hugin.info/134655/R/1549445/476460.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#1549445]
Unternehmensinformation / Kurzprofil:
Datum: 24.09.2011 - 00:02 Uhr
Sprache: Deutsch
News-ID 69137
Anzahl Zeichen: 15065
contact information:
Town:
Oslo
Kategorie:
Business News
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"Alpharadin Significantly Improves Overall Survival for Patients with Castration-Resistant Prostate Cancer and Symptomatic Bone Metastases"
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