Algeta ASA : Further sub-analyses of ALSYMPCA phase III study presented at 2013 Genitourinary Cancers Symposium

Algeta ASA : Further sub-analyses of ALSYMPCA phase III study presented at 2013 
Genitourinary Cancers Symposium 
OSLO, NORWAY -- (Marketwire) -- 02/15/13 --  
Intended for US Media only 
Abstracts #11 & #19 
Algeta ASA (OSE: ALGETA) announces that further sub-analyses of data
from the phase III ALSYMPCA study of radium Ra 223 dichloride
(radium-223) in castration-resistant prostate cancer (CRPC)
patients
have been presented at the 2013 Genitourinary Cancers
Symposium[1] (14-16 February 2013, Orlando, FL, USA). 
Radium-223 is  an  investigational  alpha  particle-emitting
pharmaceutical  in development  for CRPC patients with  bone
metastases and is  not approved by the European  Medicines Agency
(EMA),  the US Food  and Drug Administration (FDA) or other health
authorities. 
Gillies  O'Bryan-Tear, Algeta's  Chief Medical  Officer, said: "These
additional
analyses  from  ALSYMPCA  continue  to  support 
radium-223's potential  in the
treatment of men with CRPC that has
metastasized to the bone." 
Abstract  #11 by Vogelzang et  al. found that radium-223 treatment
significantly
delayed  time to first  skeletal-related event (SRE) 
versus placebo by a median
increase  of  5.8 months  (median  time 
to  SRE:  15.6 vs  9.8 months; HR=0.66;
P<0.001). 
Abstract  #19 by  Nilsson et  al. described  an analysis  of pain
parameters in ALSYMPCA.  The analysis showed  that, compared to 
placebo in CRPC patients with
bone  metastases, patients  treated
with  radium-223 had significantly prolonged
median  time to  first
palliative  external beam  radiotherapy (EBRT) (HR=0.670,
P=0.00117). 
In  the ALSYMPCA trial  the most common  hematologic adverse events
for patients
treated with radium-223 and best standard of care (BSoC)
and compared to placebo
and   BSoC   included   anemia   (31%  vs. 
31%), neutropenia  (5%  vs. 1%) and thrombocytopenia (12% vs. 6%).
With respect to Grade 3 and 4 adverse events, the most  common events
included  anemia (13% vs.  13%), neutropenia (2% vs. 1%) and
thrombocytopenia  (6% vs. 2%). The most common non-hematologic
adverse events in patients  treated with radium-223 and BSoC compared
to placebo and BSoC included
bone  pain  (50%  vs.  62%), nausea 
(36%  vs.  35%), diarrhea (25% vs. 15%) and vomiting  (19% vs. 14%).
With  respect to Grade  3 to 4 adverse events, the most
common events
included bone pain (21% vs. 26%). 
In  September 2009, Algeta  signed an  agreement with  Bayer Pharma 
AG (Berlin,
Germany)  for  the  development  and  commercialization of
radium-223. Under the terms  of the agreement,  Bayer will develop, 
apply for global health authority
approvals, and commercialize
radium-223 globally. Algeta will co-promote radium-223 with Bayer in
the US, and is eligible for milestones as well as royalties on
Bayer's sales outside the US. The ALSYMPCA trial was initiated by
Algeta in June
2008. 
References 
Abstract  #11 - Vogelzang,  N. et al.  Updated analysis of radium-223
dichloride
(Ra-223) impact  on skeletal-related  events (SRE)  in
patients with castration-resistant  prostate  cancer  (CRPC)  and 
bone  metastases from  the  phase III randomized trial (ALSYMPCA). 
Abstract  #19 - Nilsson, S.  et al. Pain analysis  from the phase III
randomized
ALSYMPCA   study  with  radium-223 dichloride  (Ra-223) in
 castration-resistant prostate cancer (CRPC) patients with bone
metastases. 
### 
About the ALSYMPCA Trial 
The  ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial was a
phase III,
randomized,  double-blind, placebo-controlled international
study of radium-223
with  best standard  of care  (BSoC) vs  placebo
with  BSoC in  symptomatic CRPC
patients with bone metastases. The
trial enrolled 921 patients in more than 100
centers  in 19
countries. The study treatment consisted of up to six
intravenous
administrations  of radium-223 or placebo each separated 
by an interval of four
weeks. 
The  primary endpoint  of the  study was  overall survival. 
Secondary endpoints
included  time to  occurrence of  skeletal-related
events  (SRE), time  to total
alkaline  phosphatase  (ALP)  and 
prostate-specific  antigen (PSA) progression,
total ALP response and
normalization, safety, and quality of life. 
About CRPC and Bone Metastases 
Prostate cancer is the most common cancer among men in the United
States (other
than skin cancer)[2].Approximately 16% of prostate
cancer cases are considered
regional or distant, which means that the
cancer has spread beyond the prostate
to nearby or distant areas of
the body (metastasis)[3]. A majority of men with CRPC have
radiological evidence of bone metastases[4].
Bone metastases
secondary to prostate cancer typically target the lumbar
spine,
vertebrae and pelvis[5].In fact, bone metastases are the main
cause of morbidity
and death in patients with CRPC[6]. About Radium
Ra 223 Dichloride 
Radium  Ra  223 dichloride  (radium-223), formerly  referred  to  as
radium-223
chloride,  is  an  investigational  alpha 
particle-emitting pharmaceutical  in development for CRPC patients
with bone metastases. 
Radium-223 is  an  investigational  agent  and  is  not approved by
the European
Medicines  Agency  (EMA),  the  US  Food  and Drug
Administration (FDA) or other
health authorities. Bayer submitted a
Marketing Authorization Application to the EMA  and a New Drug 
Application to the FDA  for radium-223 in December 2012 for the
treatment of CRPC patients with bone metastases. 
About Algeta 
Algeta  is a company focused on developing novel targeted therapies
for patients
with   cancer  based  on  its  alpha-pharmaceutical 
platform.  The Company  is headquartered in Oslo, Norway, and has a
US subsidiary, Algeta US, LLC, based in Cambridge,  MA performing
commercial  marketing operations in  the US. Algeta is listed  on the
Oslo Stock Exchange (Ticker: ALGETA). For more information
please
visit www.algeta.com. 
Forward-looking Statements 
This  news release contains certain forward-looking statements that
are based on uncertainty,  as they  relate to  events and  depend on 
circumstances that will
occur in the future and which, by their
nature, may have an impact on  results of operations   and   the 
financial  condition  of  Algeta. Such  forward-looking statements 
reflect our current views and are based on the information currently
available to Algeta. Algeta cannot give any assurance as to whether
such forward
looking  statements will prove  to be correct.  These
forward looking statements
include  statements regarding our
anticipated  co-promotion of radium-223 in the US.   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. These factors include,
among other things, risks or uncertainties  associated with  the
ability  to identify  and hire  a sufficient
number of qualified
employees for the US field force, growth management, general
economic
 and business  conditions and  the pricing  environment, the impact
of competition, the ability to successfully commercialize radium-223,
the risk that
costs  associated  with  the  co-promotion  of 
radium-223 may  be  greater than
anticipated, manufacturing capacity,
the risk of non-approval of patents not yet granted,  risks in
obtaining  regulatory approvals for  radium-223 and the other
risks
and uncertainties described in our annual report. 
[1]The 2013 Genitourinary Cancers Symposium is co-sponsored by the
American Society of Clinical Oncology (ASCO), the American Society for
Radiation Oncology
(ASTRO) and the Society of Urologic Oncology (SUO). 
[2] American Cancer Society. Prostate Cancer: Detailed Guide. October
26, 2012.
Available at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf.
Accessed
May 17, 2012 
[3] National Cancer Institute, Surveillance Epidemiology and End
Results (SEER).
SEER Stat Facts: Prostate; Survival & Stage, 2002-2008 
[4] Sartor, O. "Radiopharmaceutical and chemotherapy combinations in
metastatic
castrate-resistant prostate cancer: a new beginning." JCO.
2009;15:2417- 2418 
[5] Bone and Cancer Foundation. Questions & Answers about Prostate
Cancer Bone
Metastases and Treatment-Related Osteoporosis. Available
at:
http://www.boneandcancerfoundation.org/pdfs/prostate-cancer-qa.pdf.
Accessed
May 17, 2012 
[6] Lange PH, Vasella RL. "Mechanisms, hypotheses and questions
regarding prostate cancer metastatic to bone." Cancer & Metastasis
Reviews.1999;17:331-336 
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[HUG#1678362] 
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