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Algeta Announces Radium-223 Chloride Met its Primary Endpoint of Significantly Improving Overall Survival in a Phase III Trial in Patients With Castration-Resistant Prostate Cancer That Has Spread to the Bone

June 6, 2011

OSLO, Norway, June 6, 2011 /PRNewswire-FirstCall/ –

– Trial Stopped Based on Data Results from Pre-Planned Interim Analysis;
Patients in Placebo Arm Will Be Offered Treatment with Radium-223 Chloride

Algeta ASA (OSE: ALGETA) today announced that the Phase III ALSYMPCA
(radium-223 chloride in SYMptomatic Prostate CAncer) trial evaluating the
investigational compound radium-223 chloride, which is exclusively licensed
by Bayer, in patients with castration-resistant prostate cancer (CRPC) and
bone metastases met its primary endpoint by significantly improving overall
survival. Based on a recommendation from the Independent Data Monitoring
Committee (IDMC), following a pre-planned interim analysis, the study will be
stopped and patients on the placebo arm will be offered treatment with
radium-223 chloride. The overall survival result was statistically
significant (two-sided p-value =0.0022, HR = 0.699, the median overall
survival was 14.0 months for radium-223 chloride and 11.2 months for
placebo). The complete results from the study will be presented at an
upcoming scientific meeting.

The safety and tolerability of radium-223 chloride were consistent with
previous Phase I and Phase II trial outcomes and did not show any new or
unexpected changes in the safety profile of radium-223 chloride. Common
adverse events from the ALSYMPCA trial included diarrhea, neutropenia and
thrombocytopenia

Radium-223 chloride is an investigational agent and is not approved by
the U.S. Food and Drug Administration (FDA), the European Medicines Agency
(EMA) or other health authorities.

“We are pleased that radium-223 met its primary endpoint of significantly
improving overall survival in patients with CRPC and bone metastases, and are
hopeful about the potential of radium-223 chloride for this patient
population,” said Andrew Kay, President and CEO of Algeta.

The filing strategy for radium-223 chloride based on the IDMC’s
recommendation to stop this study, is being evaluated and patients in the
placebo arm will be offered treatment with radium-223 chloride.

Phase III Trial Design

The ALSYMPCA trial is a Phase III, randomized (2:1), double-blind,
multi-dose, placebo-controlled international study of radium-223 plus current
standard of care compared with placebo plus current standard of care in
patients with symptomatic castration-resistant/hormone-refractory prostate
cancer that has spread to the bone. The primary endpoint of the study is
overall survival. Secondary endpoints include time to occurrence of skeletal
related events (SRE), changes and time to progression in prostate-specific
antigen (PSA) tests and alkaline phosphatase (ALP) tests, safety and impact
on quality of life and health economics. ALSYMPCA was initiated by Algeta ASA
(Oslo, Norway) in June 2008. Enrollment in the trial was completed in January
2011
and 922 patients were randomized.

About Radium-223 Chloride

Radium-223 chloride is an investigational pharmaceutical containing an
alpha-particle emitting nuclide in development for cancer patients with bone
metastases. In September 2009, Bayer signed an agreement with Algeta for the
development and commercialization of radium-223 chloride. Under the terms of
the agreement, Bayer will develop, apply for global health authority
approvals, and commercialize radium-223 chloride globally, while Algeta
retains an option for up to 50/50 co-promotion and profit-sharing in the
United States
.

About CRPC and Bone Metastases

Prostate cancer is the most common cancer among men in Northern European
countries and the United States. In 2008, an estimated 903,000 men had
prostate cancer and 250,000 died from the disease worldwide.

Castration-resistant prostate cancer (CRPC) was formerly known as
hormone-refractory prostate cancer (HRPC). Approximately 90 percent 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. In fact, bone metastases are the main cause of disability and
death in patients with CRPC.

About Algeta

Algeta is a company focused on developing novel targeted therapies for
patients with cancer based on its alpha-pharmaceutical platform.

Radium-223 chloride is being developed under a development and
commercialization agreement with Bayer Schering Pharma AG, and is in a global
phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from
castration-resistant prostate cancer (CRPC). Radium-223 chloride 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 in for bone
metastases CRPC patients.

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).

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.


SOURCE Algeta


Source: newswire



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