LUND, SWEDEN and PARIS--(Marketwire - October 01, 2012) - Active Biotech (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) have presented a new set
of
data on biomarkers from the previously concluded tasquinimod Phase II study
in
chemotherapy-naïve metastatic castrate resistant prostate cancer (CRPC)
at the
scientific congress ESMO (European Society for Medical Oncology) held in
Vienna
September 28-October 2.
Dr Michael Carducci, Johns Hopkins Medical Institute, Baltimore, US,
presented
on Saturday September 29 the poster "Tasquinimod mechanism of action
biomarkers:
Correlation with PFS and survival in men with metastatic castrate
resistant
prostate cancer treated in a randomized phase 2 trial*".
The purpose of this analysis from the phase II trial was to investigate
the
effects of tasquinimod on selected biomarkers to confirm preclinical findings
on
the mechanism of action. The results support an effect of tasquinimod on
both
immunomodulation and angiogenesis which positions tasquinimod as a
potentially
unique therapeutic approach with a mechanism of action that does not target
the
androgen receptor pathway.
The findings shall be further validated in the ongoing phase III
placebo-
controlled study in men with bone-metastatic CRPC, which has been
adequately
powered to detect an OS improvement. The study will include about 1,200
patients
in more than 250 centers. Recruitment is proceeding according to plan with
top
line results expected by the end of 2013.
For more detailed information, please see www.esmo.org. The presentation
is
available on Active Biotech's web site www.activebiotech.com.
* M.A. Carducci, A.J. Armstrong, M. Häggman, W.M. Stadler, J.R.
Gingrich, V.
Assikis, J. A. Olsson, Ö. Nordle, G. Forsberg, R. Pili.
About tasquinimod
Tasquinimod has a pleiotropic mode of action which includes
immunomodulatory,
anti-angiogenic and anti-metastatic activity. Today the development
of
tasquinimod is principally focused on the treatment of prostate cancer. It
was
announced in December 2009 that the primary endpoint of the Phase II
clinical
study, to show a higher fraction of patients with no disease progression
during
the six-month period of treatment using tasquinimod, had been met. Phase
II
results were published in Journal of Clinical Oncology in September 2011.
About tasquinimod phase II
A global clinical trial 2:1 randomized, placebo controlled, double-blind
Phase
II trial investigating up to 1 mg/day of TASQ versus placebo in 206
asymptomatic
patients with metastatic castrate resistant prostate cancer (CRPC). The
primary
endpoint defined as proportion of patients with disease progression at
six
months, was reached. The results showed that 6 month progression-
free
proportions for TASQ and placebo groups were 69% and 37%,
respectively
(p < .0001). The median progression free survival was 7.6 months for the
TASQ
group, compared to 3.3 months for the placebo group (p=0.0042). TASQ
treatment
also had an effect on biomarkers relevant for prostate cancer progression
and
was generally well tolerated. Analysis of up to three years safety data from
the
Phase II study, presented at the EAU February 2012, show that treatment
side
effects were mild to moderate (~ 5% of AEs grade 3-4), manageable and
less
frequent after two months of therapy. The adverse events observed
included
gastrointestinal disorders, primarily observed initially during
treatment,
fatigue and musculoskeletal pain. In June, 2012, overall survival (OS) data
was
presented at ASCO (American Society of Clinical Oncology).
About tasquinimod phase III
A global, pivotal, randomized, double-blind, placebo-controlled Phase III
study
of tasquinimod in patients with metastatic CRPC is ongoing. The aim of the
study
is to confirm tasquinimod's efficacy on the disease, with
radiological
Progression Free Survival (PFS) as the primary endpoint and overall survival
as
secondary endpoint. The study will include about 1,200 patients in more
than
250 clinics. Recruitment is proceeding according to plan and top line
results
expected by the end of 2013.
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company
with
focus on autoimmune/inflammatory diseases and cancer. Projects in or
entering
pivotal phase are laquinimod, an orally administered small molecule with
unique
immunomodulatory properties for the treatment of multiple sclerosis, TASQ
for
prostate cancer as well as ANYARA for use in cancer targeted therapy,
primarily
of renal cell cancer. In addition, laquinimod is in Phase II development
for
Crohn's and Lupus. An additional project in clinical development is the
orally
administered compound 57-57 for Systemic Sclerosis. Please
visit
www.activebiotech.com for more information.
Active Biotech's Safe Harbor Statement in Accordance with the Swedish
Securities
Market Act
This press release contains certain forward-looking statements. Such
forward-looking statements involve known and unknown risks, uncertainties
and other
important factors that could cause the actual results, performance
or
achievements of the company, or industry results, to differ materially from
any
future results, performance or achievement implied by the forward-
looking
statements. The company does not undertake any obligation to update or
publicly
release any revisions to forward-looking statements to reflect
events,
circumstances or changes in expectations after the date of this press release.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales
exceeding EUR1.1 billion in 2011. Ipsen's ambition is to become a
leader in
specialty healthcare solutions for targeted debilitating diseases.
Its
development strategy is supported by four franchises: neurology /
Dysport®,
endocrinology / Somatuline®, uro-oncology / Decapeptyl(®) and
hemophilia.
Moreover, the Group has an active policy of partnerships. R&D is focused
on
innovative and differentiated technological patient-driven platforms,
peptides
and toxins. In 2011, R&D expenditure totaled more than EUR250 million, above
21%
of Group sales. The Group has total worldwide staff of close to 4,500
employees.
Ipsen's shares are traded on segment A of Euronext Paris (stock code: IPN,
ISIN
code: FR0010259150) and eligible to the "Service de Règlement
Différé" ("SRD").
The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored
Level
I American Depositary Receipt (ADR) program, which trade on the over-the-
counter
market in the United States under the symbol IPSEY. For more information
on
Ipsen, visit www.ipsen.com.
Ipsen Forward Looking Statement
The forward-looking statements, objectives and targets contained herein
are
based on the Group's management strategy, current views and assumptions.
Such
statements involve known and unknown risks and uncertainties that may
cause
actual results, performance or events to differ materially from
those
anticipated herein. All of the above risks could affect the Group's
future
ability to achieve its financial targets, which were set assuming
reasonable
macroeconomic conditions based on the information available today.
Moreover, the targets described in this document were prepared without
taking
into account external growth assumptions and potential future
acquisitions,
which may alter these parameters. These objectives are based on data
and
assumptions regarded as reasonable by the Group. These targets depend
on
conditions or facts likely to happen in the future, and not exclusively
on
historical data. Actual results may depart significantly from these
targets
given the occurrence of certain risks and uncertainties, notably the fact that
a
promising product in early development phase or clinical trial may end up
never
being launched on the market or reaching its commercial targets, notably
for
regulatory or competition reasons. The Group must face or might face
competition
from Generics that might translate into loose of market shares.
Furthermore, the Research and Development process involves several stages
each
of which involve the substantial risk that the Group may fail to achieve
its
objectives and be forced to abandon its efforts with regards to a product
in
which it has invested significant sums. Therefore, the Group cannot be
certain
that favorable results obtained during pre-clinical trials will be
confirmed
subsequently during clinical trials, or that the results of clinical trials
will
be sufficient to demonstrate the safe and effective nature of the
product
concerned. The Group also depends on third parties to develop and market some
of
its products which could potentially generate substantial royalties;
these
partners could behave in such ways which could cause damage to the
Group's
activities and financial results. The Group expressly disclaims any
obligation
or undertaking to update or revise any forward looking statements, targets
or
estimates contained in this press release to reflect any change in
events,
conditions, assumptions or circumstances on which any such statements are
based,
unless so required by applicable law.
The Group's business is subject to the risk factors outlined in its
registration
documents filed with the French Autorité des Marchés Financiers.
Active Biotech is obligated to publish the information contained in this
press
release in accordance with the Swedish Securities Market Act. This
information
was provided to the media for publication 8:30 a.m. CET on October 1, 2012.
Tasquinimod Biomarker Phase II data presented at ESMO 2012:
http://hugin.info/1002/R/1644548/529802.pdf
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Source: Active Biotech via Thomson Reuters ONE
[HUG#1644548]
