LUND, SWEDEN and PARIS--(Marketwire - May 18, 2012) - Active Biotech (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) will present
(TASQ), their prostate cancer drug candidate, at the scientific conference
ASCO Annual Meeting" to be held in Chicago (USA) on 1-5 June 2012.
presentation will provide overall survival (OS) data from the tasquinimod
II study in chemotherapy-naïve metastatic castrate resistant prostate
The poster "Tasquinimod and survival in men with metastatic castration-
prostate cancer: Results of long-term follow-up of a randomized phase
placebo-controlled trial" A.J. Armstrong, M. Häggman, W.M.
Gingrich, V.J. Assikis, J. Polikoff, S.R. Denmeade, D. J. George, C.
W.R. Clark, P. Sieber, R. Agajanian, L. Belkoff, J-E. Damber, Ö.
Forsberg, M. A. Carducci, R. Pili. will be presented on June 4 at 08:00 am
(3:00 pm CET).
The abstract released today, based on 97 events, shows that overall
after tasquinimod treatment is longer than previously reported in this
population. Median time to death was 34.2 vs. 30.2 months (tasquinimod
placebo). A preliminary subgroup analysis using the PCWG2 (Prostate
Clinical Trials Working Group 2) defined criteria showed that median time
death in the bone-metastatic subgroup was 34.2 vs. 25.6 months (tasquinimod
placebo). The impact of the cross-over design and the imbalance among groups
favor of placebo will be discussed in the presentation.
For more detailed information, please see www.asco.org.
A global, pivotal, randomized, double-blind, placebo-controlled Phase III
of tasquinimod in patients with metastatic CRPC is ongoing. The aim of the
is to confirm tasquinimod's efficacy on the disease, with
Progression Free Survival (PFS) as the primary endpoint and overall survival
secondary endpoint. The study will include about 1,200 patients in more
250 clinics. Recruitment is proceeding according to plan with top line
expected by the end of 2013.
Tasquinimod has a pleiotropic mode of action which includes
anti-angiogenic and anti-metastatic activity. Today the development
tasquinimod is principally focused on the treatment of prostate cancer. It
announced in December 2009 that the primary endpoint of the Phase II
study, to show a higher fraction of patients with no disease progression
the six-month period of treatment using tasquinimod, had been met. Phase
results were published in Journal of Clinical Oncology in September 2011. It
concluded that tasquinimod significantly slowed disease progression and
Progression Free Survival (PFS) in chemonaïve patients with metastatic
castrate-resistant prostate cancer (CRPC), alongside an acceptable side
Six month progression free proportion of patients for tasquinimod and
treatment groups were 69% and 37%, respectively (p < 0.0001), with a median
7.6 vs. 3.3 months (p=0.0042). Analysis of up to three years safety data
the Phase II study, presented at the EAU February 2012, show that treatment
effects were mild to moderate (~ 5% of AEs grade 3-4), manageable and
frequent after two months of therapy. The adverse events observed
gastrointestinal disorders, primarily observed initially during
fatigue and musculoskeletal pain.
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company
focus on autoimmune/inflammatory diseases and cancer. Projects in or
pivotal phase are laquinimod, an orally administered small molecule with
immunomodulatory properties for the treatment of multiple sclerosis,
for prostate cancer as well as ANYARA for use in cancer targeted
primarily of renal cell cancer. In addition, laquinimod is in Phase
development for Crohn's and Lupus. Further projects in clinical
comprise the two orally administered compounds, 57-57 for Systemic Sclerosis
RhuDex(®) for rheumatoid arthritis. Please visit
for more information.
Ipsen is a global specialty-driven pharmaceutical company with total
exceeding EUR1.1 billion in 2011. Ipsen's ambition is to become a
specialty healthcare solutions for targeted debilitating diseases.
development strategy is supported by four franchises: neurology /
endocrinology / Somatuline®, uro-oncology / Decapeptyl® and
Moreover, the Group has an active policy of partnerships. R&D is focused
innovative and differentiated technological patient-driven platforms,
and toxins. In 2011, R&D expenditure totaled more than EUR250 million, above
of Group sales. The Group has total worldwide staff of close to 4,500
Ipsen's shares are traded on segment A of Euronext Paris (stock code: IPN,
code: FR0010259150) and eligible to the "Service de Règlement
The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored
I American Depositary Receipt (ADR) program, which trade on the over-the-
market in the United States under the symbol IPSEY. For more information
Ipsen, visit www.ipsen.com.
Forward Looking Statement
The forward-looking statements, objectives and targets contained herein
based on the Group's management strategy, current views and assumptions.
statements involve known and unknown risks and uncertainties that may
actual results, performance or events to differ materially from
anticipated herein. All of the above risks could affect the Group's
ability to achieve its financial targets, which were set assuming
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
which may alter these parameters. These objectives are based on data
assumptions regarded as reasonable by the Group. These targets depend
conditions or facts likely to happen in the future, and not exclusively
historical data. Actual results may depart significantly from these
given the occurrence of certain risks and uncertainties, notably the fact that
promising product in early development phase or clinical trial may end up
being launched on the market or reaching its commercial targets, notably
regulatory or competition reasons. The Group must face or might face
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
objectives and be forced to abandon its efforts with regards to a product
which it has invested significant sums. Therefore, the Group cannot be
that favorable results obtained during pre-clinical trials will be
subsequently during clinical trials, or that the results of clinical trials
be sufficient to demonstrate the safe and effective nature of the
concerned. The Group also depends on third parties to develop and market some
its products which could potentially generate substantial royalties;
partners could behave in such ways which could cause damage to the
activities and financial results. The Group expressly disclaims any
or undertaking to update or revise any forward looking statements, targets
estimates contained in this press release to reflect any change in
conditions, assumptions or circumstances on which any such statements are
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
release in accordance with the Swedish Securities Market Act. This
was provided to the media for publication 08:30 a.m. CET on May 18, 2012.
Active Biotech and Ipsen to present Tasquinimod Phase II OS data:
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Source: Active Biotech via Thomson Reuters ONE