LUND, SWEDEN and PARIS--(Marketwired - April 25, 2013) -
* Primary PFS analysis now expected at the same time as first interim
survival analysis in 2014
Active Biotech (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that
companies have updated the analysis plan for the 10TASQ10 trial, a global
III clinical trial evaluating tasquinimod in patients with metastatic
castrate-resistant prostate cancer (mCRPC) who have not yet received
The companies now plan to conduct the primary PFS analysis for the
trial in 2014, at the same time as the first interim overall survival
analysis. The time point for the OS interim analysis will be driven
number of OS events. The specified number of radiographic
survival (PFS) events for the primary end-point will have been exceeded
time of interim OS analysis.
Dr. Claude Bertrand, Executive Vice president R&D, Chief Scientific
Ipsen, stated: "Based on the new regulatory and medical environment in the
of prostate cancer, we have reviewed the analysis strategy for the
trial. We now plan to conduct the 10TASQ10 primary PFS analysis in 2014
more mature data on OS will be available."
"The strategy to use interim OS analysis is a very logical way to secure
PFS and OS data", said Michael Carducci, Professor of Oncology and
the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Principal Investigator for the 10 TASQ10 clinical trial.
Professor Tomas Leanderson, President & CEO Active Biotech stated: "To
both PFS and OS data while the study is still blinded secures that this
plan provides us with the most robust data set in order to
development of the TASQ project."
The randomized, double-blind, placebo-controlled, Phase III 10TASQ10
its enrollment target in December 2012 with 1,245 randomized patients as
in the clinical protocol. The aim of the study is to confirm
efficacy, with radiological Progression Free Survival (PFS) as primary
and overall survival (OS) as key secondary endpoint. The study
patients in 37 countries covering more than 200 centers.
Tasquinimod is a novel small molecule that targets the tumor
binding to S100A9 and modulating regulatory myeloid cell functions,
immunomodulatory, anti-angiogenic and anti-metastatic properties.
also suppress the tumor hypoxic response, contributing to its effect
tumor microenvironment. Today the development of tasquinimod is
focused on the treatment of prostate cancer.
It was announced in December 2009 that the primary endpoint of the
clinical study, to show a higher fraction of patients with no
progression during the six-month period of treatment using tasquinimod, had
met. Phase II results were published in Journal of Clinical
September 2011. The results showed that 6 month progression-free
TASQ and placebo groups were 69% and 37%, respectively (p < .0001). The
progression free survival was 7.6 months for the tasquinimod group,
3.3 months for the placebo group (p=0.0042).
Analysis of up to three years safety data from the Phase II study,
the EAU February 2012, showed that treatment side effects were mild to
(~ 5% of AEs grade 3-4), manageable and less frequent after two
therapy. The adverse events observed included gastrointestinal
primarily observed initially during treatment, fatigue and musculoskeletal
In June, 2012, overall survival (OS) data was presented at ASCO
Society of Clinical Oncology).
In October, 2012, biomarker data were presented at the scientific congress
(European Society for Medical Oncology). The results support an
tasquinimod on both immunomodulation and angiogenesis positioning
a potentially unique therapeutic approach with a mechanism of action that
not target the androgen receptor pathway.
Also, in April 2013, the independent Data and Safety Monitoring Board
monitoring the ongoing Phase III trial recommended that the study
accordance with the protocol since no safety-related issues were noted.
A new Phase II, proof-of-concept clinical trial was initiated and which
establishing the clinical efficacy of tasquinimod used as maintenance
patients with mCRPC who have not progressed after a first-line docetaxel
Ipsen has also initiated an innovative Phase II proof-of-concept clinical
with tasquinimod, to evaluate the safety and efficacy of tasquinimod in
or metastatic hepato-cellular, ovarian, renal cell and gastric
patients who have progressed after standard therapies.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company
focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal
are laquinimod, an orally administered small molecule with
immunomodulatory properties for the treatment of multiple sclerosis,
for prostate cancer and ANYARA primarily for the treatment of renal cell
In addition, laquinimod is in Phase II development for Crohn's and
company also has one additional project in clinical development, the
administered compound paquinimod (57-57) for systemic sclerosis. Please
www.activebiotech.com for more information.
Active Biotech's Safe Harbor Statement in Accordance with the Swedish
This press release contains certain forward-looking statements. Such
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Ipsen is a global specialty-driven pharmaceutical company with total
exceeding EUR1.2 billion in 2012. Ipsen's ambition is to become a
specialty healthcare solutions for targeted debilitating diseases.
development strategy is supported by 3 franchises: neurology,
uro-oncology. Moreover, the Group has an active policy of partnerships.
R&D is focused on its innovative and differentiated technological
peptides and toxins. In 2012, R&D expenditure totalled close to EUR250
representing more than 20% of Group sales. The Group has close to
employees worldwide. Ipsen's shares are traded on segment A of Euronext
(stock code: IPN, ISIN code: FR0010259150) and eligible to the
Règlement Différé" ("SRD"). The Group is part of the SBF
120 index. Ipsen has
implemented a Sponsored Level I American Depositary Receipt (ADR) program,
trade on the over-the-counter market in the United States under the
IPSEY. For more information on Ipsen, visit www.ipsen.com.
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statements involve known and unknown risks and uncertainties that may
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macroeconomic conditions based on the information available today.
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into account external growth assumptions and potential future
which may alter these parameters. These objectives are based on
assumptions regarded as reasonable by the Group. These targets
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Active Biotech is obligated to publish the information contained in this
release in accordance with the Swedish Securities Market Act. This
was provided to the media for publication 7:00 am. CET on April 25, 2013.
Active Biotech and Ipsen update the analysis plan for the 10TASQ10:
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Source: Active Biotech via Thomson Reuters ONE