OSLO, NORWAY--(Marketwire - February 15, 2013) -
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
Press release:
http://hugin.info/134655/R/1678362/547751.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
[HUG#1678362]
