OSLO, August 28, 2008 /PRNewswire-FirstCall via COMTEX/ -- - Results Further
Support the Clinical Profile of This Novel Anti-Cancer Agent Under Development
to Improve the Survival of Patients With Hormone Refractory Prostate Cancer
(HRPC)
Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today
announced that the primary objective of its BC1-03 Phase II pain palliation
study was met. The study showed that even single doses of Alpharadin in patients
with painful bone metastases could produce increasing clinical benefit with
increasing dose. Pain palliation is an important quality of life benefit in
metastatic cancer patients. The trial also confirmed Alpharadin's benign
side-effect profile and, importantly for a drug in this clinical setting, no
significant bone marrow toxicity was observed.
In men with HRPC life expectancy can be as short as 18 months, and it is
estimated that 100,000 men in the EU and USA die from the disease each year. In
85% of these men the tumor will have spread into the bones. These metastases are
a significant problem as they can cause intractable and debilitating pain as
well as contributing to a further reduction in life expectancy.
The BC1-03 study was a double-blind randomised pain control study comparing the
palliative effects of four different single dose levels of Alpharadin in
patients with bony metastatic HRPC. The drug was given by i.v. injection mainly
on an outpatient basis. The palliative efficacy of Alpharadin was measured using
an assessment of bone pain as well as the patient's consumption of analgesia.
The primary study objective was to investigate whether there was a dose-response
relationship with respect to pain palliation in this patient group. The study
has shown the beneficial palliative effect of a single dose of Alpharadin and
that there is a clear dose-response effect, with higher doses providing better
pain relief.
The study also showed a dose-dependent reduction in bone alkaline phosphatase
(ALP) ranging from no effect in the lowest dose group to a marked reduction in
the higher dose groups. ALP is a severity marker of bony metastatic disease and
of prognostic importance.
The study has also further confirmed the safety of Alpharadin and shown its
benign side-effect profile. In fact, the higher the dose of Alpharadin that
patients received, the fewer adverse events were experienced. This reproduces
the safety profile of the earlier BC1-02 Phase II study where the Alpharadin
group experienced fewer adverse effects than the placebo comparator group.
Importantly for a drug in this clinical setting no significant bone marrow
toxicity was observed in patients receiving Alpharadin.
The full results of the BC1-03 study will be submitted for publication in a
peer-reviewed journal.
The principal investigator of the study Professor Sten Nilsson at the Karolinska
Hospital in Stockholm said: "These results showing the beneficial impact of
Alpharadin in terms of pain palliation are important, as improved quality of
life, alongside increased survival, are the two key goals of anti-cancer therapy
of patients with skeletal metastases."
Commenting on today's further positive news with Alpharadin, Algeta's President
and CEO, Dr. Thomas Ramdahl, said: "These results build on the positive Phase II
clinical data package that we have already assembled with Alpharadin, the
highlight of which was the significant survival benefits that we have already
reported in patients with HRPC.
Based on our clinical trials to-date I am very confident that Alpharadin has the
potential to become an important new therapy for patients with prostate cancer.
This view has been reinforced by the enthusiastic and positive response we have
received from key opinion leaders around the world to our unique approach to
treating HRPC."
Algeta has recently started enrolling patients for the pivotal Phase III
ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study. This international
study will evaluate Algeta's targeted therapeutic Alpharadin in advanced,
hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton.
Approximately 750 patients are expected to be enrolled at more than 125 medical
centers in Europe, Asia, South America and Canada. The Coordinating Investigator
for the study is Dr. Christopher Parker, a leading clinical oncologist and
specialist in prostate cancer, based at the Institute of Cancer Research and the
Royal Marsden Hospital in the UK.
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, has commenced an international
phase III clinical trial in hormone-refractory prostate cancer (ALSYMPCA) based
on positive phase II results. Alpharadin is a novel bone-seeking therapeutic
based on the alpha particle emitter radium-223 and may target skeletal
metastases from multiple cancer types, as well as primary bone cancers.
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.
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.
For further information, please contact:
Dr. Thomas Ramdahl, CEO,
+47-23-00-79-90 / +47-913-91-458 (mob);
0ystein Soug, CFO,
+47-23-00-79-84 / +47-906-56-525 (mob),
post@algeta.com;
For international enquiries:
Dr. Mark Swallow / David Dible,
Citigate Dewe Rogerson,
+44(0)207-638-9571,
mark.swallow@citigatedr.co.uk
SOURCE Algeta
www.prnewswire.com
