�Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, announced that the primary objective of its BC1-03 Phase II bother
palliation survey 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 tribulation
also confirmed Alpharadin's benign side-effect visibility and, importantly for
a drug in this clinical setting, no significant os marrow toxicity was
observed.
In manpower with HRPC life anticipation 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 ar a pregnant problem as they bathroom cause intractable and
debilitating pain as well as contributing to a farther reduction in life
expectancy.
The BC1-03 study was a double blind randomised pain control study
comparing the palliative personal effects of four-spot different single dose levels of
Alpharadin in patients with boney metastatic HRPC. The do drugs was given by
i.v. shot mainly on an outpatient basis. The palliative efficaciousness of
Alpharadin was deliberate using an assessment of bone pain as comfortably 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 good
palliative effect of a single dosage of Alpharadin and that there is a net
dose-response effect, with higher doses providing better pain in the ass relief.
The study likewise showed a dose-dependent simplification in os alkaline
phosphatase (ALP) ranging from no effect in the lowest dose mathematical group to a
marked reduction in the higher dot groups. ALP is a severity marker of
gaunt metastatic disease and of prognostic importance.
The study has also further confirmed the safe of Alpharadin and shown
its benign side-effect profile. In fact, the higher the elvis of Alpharadin
that patients received, the fewer inauspicious events were experienced. This
reproduces the safety profile of the earlier BC1-02 Phase II study where
the Alpharadin group experienced fewer inauspicious effects than the placebo
comparator group. Importantly for a do drugs 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 research worker of the study Professor Sten Nilsson at the
Karolinska Hospital in Stockholm said: "These results display the
good impact of Alpharadin in terms of pain palliation are important,
as improved quality of life, aboard increased survival, are the two key fruit
goals of anti-cancer therapy of patients with pinched 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 substantial survival benefits
that we have already reported in patients with HRPC.
Based on our clinical trials to-date I am identical confident that
Alpharadin has the potency to become an crucial new therapy for
patients with prostate cancer. This view has been reinforced by the
enthusiastic and positive response we have received from key judgment
leaders around the humans to our unique coming to treating HRPC."
Algeta has lately started enrolling patients for the polar Phase
III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study. This
international written report will valuate Algeta's targeted therapeutic Alpharadin
in advanced, hormone-refractory prostate gland cancer (HRPC) that has
metastasized to the skeleton. Approximately 750 patients ar expected to be
enrolled at more than cxxv 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 the Crab,
based at the Institute of Cancer Research and the Royal Marsden Hospital in
the UK.
About Algeta
Algeta ASA is a Norwegian genus Cancer therapeutics company built on
world-leading, proprietary technology. Algeta is developing new, targeted
cancer therapeutics that harness the alone characteristics of alpha
subatomic particle emitters and are virile, 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 wasted metastases from multiple genus Cancer types, as well as
primary ivory cancers.
Algeta is besides 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
Thursday 4 September 2008
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