Active Biotech and Ipsen report for the first time Tasquinimod (TASQ) phase II long term safety data at the 27th European Association of Urology (EAU) Congress
24 februari 2012
Lund (Sweden) and Paris (France), February 24, 2012 - Active Biotech's (NASDAQ
OMX NORDIC: ACTI) and Ipsen's (Euronext: IPN; ADR: IPSEY) castrate resistant
prostate cancer project, TASQ will be presented at the 27th Annual EAU Congress
held in Paris on 24-28 February 2012. The presentation will detail the analysis
of up to three years safety data from the TASQ Phase II study in chemotherapy-
naïve metastatic castrate resistant prostate cancer (CRPC).
The poster "Long term safety and efficacy in a randomized multicenter
international phase II study of tasquinimod in chemotherapy naïve patients with
metastatic castrate-resistant prostate cancer" A.J. Armstrong, J.R. Gingrich, M.
Häggman, W.M. Stadler, J.E. Damber, L. Belkoff, R. Clark, S. Brosman, O. Nordle,
G. Forsberg, M.A. Carducci, R. Pili. will be presented on February 25 at 2:15 pm
CET. The poster will combine the long term safety data and the already published
encouraging efficacy data, published in the Journal of Clinical Oncology (JCO)
in September 2011. The poster will be publically available after the
presentation on www.activebiotech.com,
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.
Andrew J. Armstrong, Associate Professor of Medicine and Surgery and Medical
Oncologist at Duke University, tasquinimod Phase II investigator, said: "These
long term safety data are of critical importance as tasquinimod is being
evaluated in elderly men with castrate resistant prostate cancer, and standard
treatment of these patients will include a sequence of active therapies used for
long periods of time. These new data show that tasquinimod long term safety is
acceptable. Tasquinimod may therefore be a suitable therapy to evaluate at an
early stage in management of CRPC, either as monotherapy or in combination with
other effective agents for prostate cancer, as it does not jeopardize the
patient's chances to receive additional treatment".
A global, pivotal, randomized, double-blind, placebo-controlled Phase III study
of TASQ in patients with metastatic CRPC is ongoing. The aim of the study is to
confirm TASQ's effect on the disease, with radiological PFS as the primary
endpoint and overall survival as secondary endpoint. The study will include
about 1,200 patients in more than 250 clinics.
The independent Data and Safety Monitoring Board (DSMB) overseeing the ongoing
Phase III clinical trial has recommended the study to proceed as per protocol as
no safety concern were identified.
About TASQ
The development of TASQ is principally focused on the treatment of prostate
cancer. Studies have concluded that TASQ exhibits immunomodulatory, anti-
angiogenic and anti-metastatic activity. 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 TASQ, had been met. Final Phase II results were published in Journal of
Clinical Oncology in September 2011. It was concluded that TASQ significantly
slowed disease progression and improved Progression Free Survival (PFS) in
patients with metastatic castrate-resistant prostate cancer (CRPC), alongside an
acceptable side effect profile. Six month progression free proportion of
patients for TASQ and placebo treatment groups were 69% and 37%, respectively
(p<0.0001), with a median PFS of 7.6 vs. 3.3 months (p=0.0042).
About Active Biotech
Active Biotech AB (NASDAQ OMX NORDIC:ACTI) is a biotechnology company with focus
on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are
laquinimod, an orally administered small molecule with unique immunomodulatory
properties for the treatment of multiple sclerosis, TASQ for prostate cancer and
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. Further
projects in clinical development comprise the two orally administered compounds,
57- 57 for Systemic Sclerosis as well as RhuDexTM for RA. Please
visitwww.activebiotech.com for more information.
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00
Active Biotech is required under the Securities Markets Act to make the
information in this press release public.
The information was submitted for publication at 08:30 a.m. CET on February
24, 2012.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total sales
exceeding €1.1 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 2010, R&D expenditure totaled more than €220 million, above 20%
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, visitwww.ipsen.com.
Ipsen's 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 favourable 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.
For further information, please contact:
Active Biotech
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
tomas.leanderson@activebiotech.com
Ipsen
Media
Didier Véron
Director, Public Affairs and Corporate Communications
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail:didier.veron@ipsen.com
Financial Community
Pierre Kemula
Investor Relations Officer
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
E-mail:pierre.kemula@ipsen.com
Stéphane Durant des Aulnois
Investor Relations Manager
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58 33 50 63
E-mail:stephane.durant.des.aulnois@ipsen.com
Active Biotech and Ipsen report:
http://hugin.info/1002/R/1588162/498322.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: Active Biotech via Thomson Reuters ONE
[HUG#1588162]