LUND, SWEDEN--(Marketwire - February 24, 2012) - Active Biotech's (NASDAQ
OMX NORDIC: ACTI) and Ipsen's (Euronext: IPN; ADR: IPSEY) castrate
prostate cancer project, TASQ will be presented at the 27th Annual EAU
held in Paris on 24-28 February 2012. The presentation will detail the
of up to three years safety data from the TASQ Phase II study in
chemotherapy-naïve metastatic castrate resistant prostate cancer
The poster "Long term safety and efficacy in a randomized multicenter
international phase II study of tasquinimod in chemotherapy naïve
metastatic castrate-resistant prostate cancer" A.J. Armstrong, J.R.
Häggman, W.M. Stadler, J.E. Damber, L. Belkoff, R. Clark, S. Brosman,
G. Forsberg, M.A. Carducci, R. Pili. will be presented on February 25 at
CET. The poster will combine the long term safety data and the already
encouraging efficacy data, published in the Journal of Clinical Oncology
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),
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
Oncologist at Duke University, tasquinimod Phase II investigator, said:
long term safety data are of critical importance as tasquinimod is being
evaluated in elderly men with castrate resistant prostate cancer, and
treatment of these patients will include a sequence of active therapies
long periods of time. These new data show that tasquinimod long term safety
acceptable. Tasquinimod may therefore be a suitable therapy to evaluate at
early stage in management of CRPC, either as monotherapy or in combination
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
of TASQ in patients with metastatic CRPC is ongoing. The aim of the study
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
Phase III clinical trial has recommended the study to proceed as per
no safety concern were identified.
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
the primary endpoint of the Phase II clinical study, to show a higher
of patients with no disease progression during the six-month period of
using TASQ, had been met. Final Phase II results were published in Journal
Clinical Oncology in September 2011. It was concluded that TASQ
slowed disease progression and improved Progression Free Survival (PFS) in
patients with metastatic castrate-resistant prostate cancer (CRPC),
acceptable side effect profile. Six month progression free proportion of
patients for TASQ and placebo treatment groups were 69% and 37%,
(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
on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase
laquinimod, an orally administered small molecule with unique
properties for the treatment of multiple sclerosis, TASQ for prostate
ANYARA for use in cancer targeted therapy, primarily of renal cell cancer.
addition, laquinimod is in Phase II development for Crohn's and Lupus.
projects in clinical development comprise the two orally administered
57- 57 for Systemic Sclerosis as well as RhuDexTM for RA. Please
Visit www.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
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 /
endocrinology / Somatuline®, uro-oncology / Decapeptyl® and
Moreover, the Group has an active policy of partnerships. R&D is focused on
innovative and differentiated technological patient-driven platforms,
and toxins. In 2010, R&D expenditure totaled more than EUR220 million,
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
market in the United States under the symbol IPSEY. For more information on
Ipsen, visit www.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.
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
macroeconomic conditions based on the information available today.
Moreover, the targets described in this document were prepared without
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
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
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 favourable 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 product
concerned. The Group also depends on third parties to develop and market
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
or undertaking to update or revise any forward looking statements, targets
estimates contained in this press release to reflect any change in events,
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
documents filed with the French Autorité des Marchés Financiers.
Active Biotech and Ipsen report:
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Source: Active Biotech via Thomson Reuters ONE