Results highlight the potential of Alpharadin to treat bone
metastases in major cancer indications
Oslo, Norway, 14 January 2009 - 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 offers 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
supports 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. Thomas Ramdahl, said: "The completion
of 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."
Dr Chris Parker, a prostate cancer specialist based at the Institute
of Cancer Research and the Royal Marsden Hospital in Sutton, UK, and
the study's 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 June 2008.
Approximately 750 patients are expected to be enrolled in Europe,
Asia, South America and Canada.
For more information on the ALSYMPCA trial, please go to
www.algeta.com and click on the ALSYPMCA link in the menu bar.
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For further information, please contact
Dr. Thomas Ramdahl, President +47 23 00 79 90 / +47 913 91 458 (mob)
& CEO +47 23 00 79 84 / +47 906 56 525 (mob)
Øystein Soug, CFO post@algeta.com
For international enquiries: +44 (0)207 638 9571
Dr. Mark Swallow / David Dible mark.swallow@citigatedr.co.uk
/ Helena Galilee
Citigate Dewe Rogerson
About Algeta
Algeta ASA is a Norwegian 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 commercial potential.
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 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 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 treatment.
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 advanced disease.
Current treatments for skeletal metastases are largely palliative.
They include opioid analgesics, external beam radiotherapy,
beta-emitting radionuclides and bisphosphonates.
References
1. Coleman, R.E. Clinical features of metastatic bone disease and
risk of skeletal morbidity. Clin Cancer Res. 2006;12:6243s-6249s.
Review
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: 643-665
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.
Theses 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.
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