Algeta Completes Comprehensive Phase II Clinical Program With Alpharadin for Treating Bone Metastases in Patients With Advanced Prostate Cancer
– Results Highlight the Potential of Alpharadin to Treat Bone Metastases
in Major Cancer Indications
Algeta ASA (OSE: ALGETA), the cancer therapeutics company, announces that
with the results of the BC1-04 study reported today it has completed its
comprehensive phase II clinical program evaluating Alpharadin (radium-223) as
a new treatment for bone metastases in patients with hormone-refractory
prostate cancer (HRPC). The program provides strong evidence that Alpharadin
can prolong patient survival times, improve quality of life and offer a
placebo-like safety profile.
These exciting clinical results combined with Alpharadin’s unique
bone-targeting properties highlight the potential of this new cancer
therapeutic to be a first-choice treatment for bone metastases that
frequently arise from a number of high incidence cancers as well as HRPC
(e.g. breast, lung and thyroid). Bone metastases are a serious consequence of
certain advanced cancers causing intractable and debilitating pain as well as
further reducing life expectancy.
In addition, the results, including data from the final trial in the
program (BC1-04; outlined below), suggest that Alpharadin has an ideal
profile to be used in combination with other cancer therapies.
The Alpharadin phase II program comprised three trials and involved 286
individuals. It was designed to provide detailed information on the safety
and therapeutic efficacy of different doses of Alpharadin in HRPC patients,
both symptomatic and asymptomatic for bone metastases, as well as evaluating
its ability to relieve pain caused by bone metastases in symptomatic
patients. In all three phase II trials completed, the primary efficacy
endpoints were met while providing compelling evidence of the benign,
placebo-like safety profile of Alpharadin. In addition, data from the BC1-04
study support an optimal therapeutic dose level of 50 kBq/kg as selected for
use in the global phase III ALSYMPCA trial (see below for further details).
Furthermore, the successful completion of the phase II program also
supports Algeta’s strategy for targeting Alpharadin at patients with
metastatic HRPC who are unsuitable or who have failed docetaxel chemotherapy
and for first-line use in combination with docetaxel. A combination study is
in preparation, which if successful will enable Algeta to market Alpharadin,
either alone or in combination with docetaxel, to approximately 85% of the
global HRPC market.
Algeta’s President and CEO, Dr.
the phase II program is an important milestone for Algeta that gives us great
confidence in the potential of Alpharadin as a new, safe and effective
treatment for metastatic prostate cancer. The program has demonstrated not
only that Alpharadin can improve patient quality of life by successfully
treating the painful and debilitating bone metastases arising from the
primary cancer, but also that it has a proven survival benefit for patients.
We believe there is not a single cancer therapeutic available today offering
these patients such clinical benefits, let alone one which is so readily
tolerated. We remain confident that the phase III clinical program will
confirm these impressive results and support a strong case for regulatory
approval in due course.”
Cancer Research and the Royal Marsden Hospital in
principal investigator, said: “The clinical results generated so far for
Alpharadin in treating metastatic prostate cancer are highly encouraging and
offer patients the possibility of an effective treatment that both prolongs
life while also maintaining quality of life. In addition, the results
announced today further emphasize the remarkably favourable safety profile of
Alpharadin compared to other products used in the treatment of HRPC. This
major benefit of Alpharadin makes the ALSYMPCA phase III trial a very
attractive option for suitable patients as they can continue to receive best
standard care in addition to the study drug.”
Results of phase II clinical study BC1-04
The BC1-04 study was a double-blind, randomized, dose-finding,
repeat-dose study comparing three different dose levels of Alpharadin given
three times with six weeks interval to HRPC patients with skeletal
metastases. The drug was given by i.v. injection predominantly on an
outpatient basis. The primary study objective was to investigate whether
there was a dose-response relationship with respect to the proportion of
patients showing a PSA response, and to investigate the six weeks’ dosing
schedule in order to prepare for possible combination trials with docetaxel.
The primary efficacy objective was met and this showed a dose-dependent
effect across the three dose levels; 25 kBq/kg, 50 kBq/kg and 80 kBq/kg,
respectively. The secondary, but important, endpoint of bone-specific
alkaline phosphatase (b-ALP) also showed a significant dose-dependent effect
between the lowest and the two higher dose levels, as well as confirming once
more the strong bone-targeting nature of Alpharadin. ALP is a severity marker
of metastatic bone disease and of prognostic importance. Again, the benign
safety profile of Alpharadin was confirmed. Importantly for a drug in this
clinical setting no significant bone marrow toxicity was observed in patients
receiving Alpharadin, which suggests that in addition to being a product of
choice for patients with bone metastases it may also have an ideal profile to
be used in combination with other therapies.
Algeta began enrolling patients for the global phase III ALSYMPCA
(ALpharadin in SYMptomatic Prostate CAncer) study in
750 patients are expected to be enrolled in
For more information on the ALSYMPCA trial, please go to
http://www.algeta.com and click on the ALSYPMCA link in the menu bar.
Algeta ASA is a cancer therapeutics company built on world-leading,
proprietary technology. Algeta is developing new, targeted cancer
therapeutics that harness the unique characteristics of alpha particle
emitters and are potent, well-tolerated and convenient to use.
Algeta’s lead product candidate, Alpharadin (based on radium-223), has
blockbuster potential for treating bone metastases arising from multiple
major cancer types, owing to its bone-targeting nature, potent efficacy
(therapeutic and palliative) and benign, placebo-like safety profile.
Development of Alpharadin is most advanced targeting bone metastases
resulting from hormone-refractory prostate cancer (HRPC), and it entered an
international phase III clinical trial (ALSYMPCA) in mid-2008 based on
compelling clinical results from a comprehensive phase II program.
Algeta’s strategy is to launch Alpharadin as a first or second line
treatment for cancer patients with bone metastases either alone or in
combination with current standard of care therapies, thereby maximizing its
Algeta is also developing other technologies for delivering alpha
emitters. These include microparticles, liposomes, and methods to enhance the
potency of therapeutic antibodies and other tumor-targeting molecules by
linking them to the alpha particle emitter thorium-227. The Company is
Oslo Stock Exchange in
Alpharadin and Algeta are trademarks of Algeta ASA.
About Bone Metastases
Bone is the most common organ to be affected by metastatic cancer (Ref.
1). Approximately 1.5 million cancer patients suffer from bone metastases
worldwide and there are some 300,000 new cases each year. Importantly,
metastases may stay confined to the skeleton with subsequent morbidity and
eventual death almost entirely due to skeletal complications and their
Some 80% of bone metastases are due to prostate and breast carcinomas.
For these high incidence cancers, 65-75% patients with advanced disease will
have bone metastases (Ref. 2). They may suffer multiple skeletal
complications over several years because the clinical course of metastatic
bone disease is relatively long. The effects are often debilitating
(intractable bone pain, fractures, hypercalcaemia, and spinal cord
compression) and profoundly impair a patient’s quality of life.
Bone metastases also occur frequently in patients with lung, kidney and
thyroid cancers – respectively in 30-40%, 20-25% and 60% of patients with
Current treatments for skeletal metastases are largely palliative. They
include opioid analgesics, external beam radiotherapy, beta-emitting
radionuclides and bisphosphonates.
1. Coleman, R.E. Clinical features of metastatic bone disease and risk of
2. Rubens, R.D, and Coleman, R.E. Bone Metastases. In: Abaloff, M.D.,
Armitage, J.O., Lichter, A.S. and Niederhuber, J.E. Clinical Oncology 1995:
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
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technological development, the risk that research & development will not
yield new products that achieve commercial success, the impact of
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risk of non-approval of patents not yet granted and difficulties of obtaining
relevant governmental approvals for new products.
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