Algeta to Enroll US Patients Into Global Phase III ALSYMPCA Trial Following Successful End-of-Phase II Meeting With FDA
– ALSYMPCA Study Designed to Evaluate Alpharadin for the Treatment of
Bone Metastases in Prostate Cancer Patients
Algeta ASA (OSE: ALGETA), the cancer therapeutics company, announces that
it is to enroll US patients into its ALSYMPCA phase III trial evaluating
Alpharadin as a new treatment for bone metastases in patients with
hormone-refractory prostate cancer (HRPC). This decision follows a successful
end-of-phase II meeting* with the US Food and Drug Administration (FDA), held
Algeta began enrolling patients for its global phase III ALSYMPCA
(ALpharadin in SYMptomatic Prostate CAncer) study in
enroll approximately 750 HRPC patients with bone metastases. Recruitment of
US patients into the study is now planned to commence this year.
Alpharadin (radium-223) is Algeta’s lead clinical candidate and has
demonstrated in phase II studies strong evidence that it can prolong patient
survival times, improves quality of life and offers a placebo-like safety
These exciting clinical results combined with Alpharadin’s unique
bone-targeting properties highlight the potential of this novel cancer
therapeutic to be an important new treatment for bone metastases that
frequently arise from a number of high incidence cancers as well as HRPC
(e.g. breast, lung and kidney). Bone metastases are a serious consequence of
certain advanced cancers causing intractable and debilitating pain as well as
further reducing life expectancy.
discussions with FDA have been productive and we believe they have
contributed positively to the overall clinical development plan for
Alpharadin. We are therefore extremely pleased to enroll US patients into our
pivotal ALSYMPCA study following the successful end-of-phase II meeting with
the FDA. We will be focusing on initiating the study at key clinical centers
in the US over the coming months.”
ALSYMPCA phase III clinical study
The ALSYMPCA study is a double-blind, randomized, controlled trial that
enrolls symptomatic HRPC patients who will be randomized to receive
Alpharadin plus best standard of care or placebo plus best standard of care.
The primary efficacy endpoint of the trial is overall survival. Patients
are being randomized 2-to-1 in favor of Alpharadin, which will be given as
six injections of 50 kBq/kg body weight, four weeks apart. Secondary
endpoints include time to occurrence of specified disease-related events, and
time to progression of certain key biomarkers indicative of disease status,
including blood levels of serum prostate-specific antigen (PSA) and total
alkaline phosphatase (ALP). In addition, the trial will monitor and evaluate
both the acute and long-term safety profiles of Alpharadin treatment as well
as its impact on quality of life.
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
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.
* The purpose of an end-of-phase II meeting is to determine the safety of
proceeding to Phase III, to evaluate and the adequacy of current studies and
plans to assess safety and effectiveness, and to identify any additional
information necessary to support a marketing application for the uses under
For further information, please contact Andrew Kay, President & CEO +47-23-00-67-42 / +47-48-40-13-60 (mob) 0ystein Soug, CFO +47-23-00-79-84 / +47-906-56-525 (mob) firstname.lastname@example.org For international enquiries: Dr. Mark Swallow / David Dible / Helena Galilee Citigate Dewe Rogerson +44-207-638-9571 / +44-7903-737703 email@example.com