Algeta Announces First US Patient Randomized in ALSYMPCA Phase III Study at Tulane Cancer Center, New Orleans
By Algeta, PRNEThursday, December 10, 2009
OSLO, December 11 - Algeta ASA (OSE: ALGETA), the cancer therapeutics company, announces that
the first clinical center in the US, the Tulane Cancer Center, New Orleans,
has started randomizing patients in the phase III clinical study of
Alpharadin in men with castration-resistant
(also known as hormone-refractory) prostate cancer (CRPC) that has
metastasized to the skeleton.
The ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study
is a double-blind, randomized, controlled trial that enrols patients with
CRPC and symptomatic bone metastases who will be randomized to receive
Alpharadin (radium-223 chloride) plus best standard of care or placebo plus
best standard of care. Approximately 750 patients are expected to be enrolled
at more than 125 medical centers worldwide. Algeta expects to enroll patients
across up to 15 sites in the US. Global recruitment remains on schedule and
is expected to be complete by the second half of 2010.
The Principal Investigator of the ALSYMPCA study in the US is Dr. Oliver
Sartor, Piltz Professor of Cancer Research in the Departments of Medicine and
Urology at Tulane University School of Medicine at the Tulane Cancer Center
in New Orleans. The Tulane Cancer Center is one of the top cancer-focused
medical centers in the US.
Dr. Sartor is an internationally recognized medical oncologist with an
interest in prostate cancer from both a basic research and clinical
perspective. He is chair-elect of the US Department of Defense Prostate
Cancer Integration Panel and is co-editor-in-chief of the peer-reviewed
journal Clinical Genitourinary Cancer. He is also the current medical
oncology chair of the Genitourinary Cancer Committee of the Radiation
Oncology Treatment Group, a leading US multicenter research organization
testing novel radiotherapy approaches against cancer.
Dr Sartor commented: "Alpharadin works by targeting and destroying cancer
cells in the bone while sparing healthy bone marrow tissue. If successful in
clinical trials, this compound could make a significant difference for the
large number of men whose cancer has spread to the bones. Patients most often
die as a consequence of the metastases - not the primary cancer - so
preventing cancer from spreading and controlling cancer that has spread is a
major clinical challenge."
Physicians interested in referring a qualified patient may go to
www.algeta.com for further information about this study.
Andrew Kay, Algeta's President and CEO said: "We are pleased to begin the
ALSYMPCA phase III study in the US and especially excited to be working with
Dr. Sartor, an internationally recognized prostate cancer expert at the
Tulane Cancer Center, one of the world's leading cancer hospitals. The
enrolment of patients into US clinical centers is an important step in the
overall clinical development of Alpharadin and we expect further US clinical
centers to come online in the coming months."
In September, Algeta signed a USD 800 million agreement with
Bayer Schering Pharma AG for the development and global commercialization of
Alpharadin.
About Algeta
Algeta ASA is a cancer therapeutics company built on
world-leading, proprietary technology. Algeta is developing a new generation
of targeted cancer therapeutics (alpha-pharmaceuticals) that harness the
unique characteristics of alpha particle emitters and are potent,
well-tolerated and convenient to use.
Algeta's lead alpha-pharmaceutical 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 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. This trial
is currently open for recruitment.
In September 2009, Algeta entered into a global agreement with
Bayer Healthcare AG for the development and commercialization of Alpharadin.
As part of the agreement, Algeta retains an option to co-promote Alpharadin
in the United States and to share profits from future sales.
Algeta is also developing other technologies for delivering
alpha-pharmaceuticals. These include 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.
Andrew Kay, CEO +47-23-00-7990 / +47-4840-1360 (mob) Gillies O'Bryan-Tear, CMO +47-23-00-7824 / +47-4804-1411 (mob) 0ystein Soug, CFO +47-23-00-7990 / +47-9065-6525 (mob) post@algeta.com International media enquiries: +44-207-638-9571 Mark Swallow/Helena Galilee/David mark.swallow@citigatedr.co.uk Dible Citigate Dewe Rogerson US investor enquiries: +1-646-378-2928 Jessica Lloyd jlloyd@troutgroup.com The Trout Group
Andrew Kay, CEO, +47-23-00-7990 / +47-4840-1360 (mob); Gillies O'Bryan-Tear, CMO, +47-23-00-7824 / +47-4804-1411 (mob); 0ystein Soug, CFO, +47-23-00-7990 / +47-9065-6525 (mob), post at algeta.com; International media enquiries: +44-207-638-9571; Mark Swallow/Helena Galilee/David mark.swallow at citigatedr.co.uk, Dible Citigate Dewe Rogerson, US investor enquiries: +1-646-378-2928
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