Algeta Announces First US Patient Randomized in ALSYMPCA Phase III Study at Tulane Cancer Center, New Orleans
cancer therapeutics company, announces that the first clinical center in the
US, the Tulane Cancer Center,
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.
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
http://www.algeta.com for further information about this study.
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
Schering Pharma AG for the development and global commercialization of
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
Healthcare AG for the development and commercialization of Alpharadin. As
part of the agreement, Algeta retains an option to co-promote Alpharadin in
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
Alpharadin and Algeta are trademarks of Algeta ASA.
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) firstname.lastname@example.org International media enquiries: +44-207-638-9571 Mark Swallow/Helena Galilee/David email@example.com Dible Citigate Dewe Rogerson US investor enquiries: +1-646-378-2928 Jessica Lloyd firstname.lastname@example.org The Trout Group