LUND, SWEDEN--(Marketwire - October 03, 2012) -
Paris (France) and Lund (Sweden), 3 October 2012 - Ipsen (Euronext: IPN;
ADR: IPSEY) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced
the initiation of a new phase II proof of concept clinical trial,
evaluating the activity of tasquinimod in advanced metastatic castrate
resistant prostate cancer patients. The study aims at establishing the
clinical efficacy of tasquinimod used as maintenance therapy in patients
with metastatic castrate-resistant prostate cancer (mCRPC) who have not
progressed after a first line docetaxel based chemotherapy.
Karim Fizazi, Head of the Cancer Medicine Department of the Institut
Gustave Roussy (IGR) in France and Principal investigator of the study
said: "In current clinical practice, metastatic castrate-resistant prostate
cancer patients with non-progressive disease after docetaxel treatment are
not proposed any medication as no reference/standard treatment exists.
These patients remain untreated until disease progression. Prolongation of
the response to first line chemotherapy (consolidation) represents an unmet
need for which patients and physicians request further therapeutic options.
'Switch maintenance' therapy with manageable safety profile such as
tasquinimod could be one strategy to prolong treatment response, without
significantly compromising quality of life."
Claude Bertrand, Executive Vice-President R&D, Chief Scientific Officer of
Ipsen said: "Ipsen is highly committed to the treatment of prostate cancer.
Maintenance therapy in prostate cancer might be a viable therapeutic
paradigm, as demonstrated in other tumor types." Claude Bertrand added:
"With its distinct mode of action and the encouraging data demonstrated in
phase II, tasquinimod has the potential to provide advanced prostate cancer
patients with a new treatment option supported by an innovative therapeutic
The "switch maintenance" trial is part of the initial agreement with Active
Biotech to enhance tasquinimod's data package beyond the ongoing phase III
placebo-controlled study in men with bone-metastatic CRPC, which has been
adequately powered to detect an OS improvement. The phase III 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
About the Proof Of Concept "switch maintenance" Phase II trial
A global, 2:1 randomized, placebo controlled, double-blind Phase II trial
investigating up to 1 mg/day of taquinimod versus placebo in 150 metastatic
castrate resistant prostate cancer (mCRPC) patients who have not progressed
after a first line docetaxel based chemotherapy. The primary endpoint of
the study is radiological progression free survival. The study will be
recruited across about 50 centers in Europe.
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. In June, 2012, overall
survival (OS) data was presented at ASCO (American Society of Clinical
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, tasquinimod 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
http://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.
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. Ipsen's R&D is
focused on its innovative and differentiated technological 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'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
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
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 6:30 p.m. CET on
October 3, 2012.
Ipsen initiates a phase II ?Switch maintenance? trial in metastatic ca:
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Source: Active Biotech via Thomson Reuters ONE