Active Biotech's and Ipsen's Tasquinimod shows encouraging overall survival improvement in castrate resistant prostate cancer
(Thomson Reuters ONE) -
Phase II Overall Survival data presented at
the 2012 ASCO Annual Meeting
Lund (Sweden) and Paris (France), June 4, 2012. Active Biotech (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) today presented overall
survival (OS) data from the tasquinimod Phase II study in chemotherapy-naïve
metastatic castrate resistant prostate cancer (CRPC) at the scientific
conference "2012 ASCO Annual Meeting" held in Chicago (USA).
Today at 08:00 am CDT (3:00 pm CET) Dr. Andrew J. Armstrong from the Duke Cancer
Institute (Durham, NC) presented "Tasquinimod and survival in men with
metastatic castration-resistant prostate cancer: Results of long-term follow-up
of a randomized phase II placebo-controlled trial*" in a poster discussion
session.
The intention-to-treat analysis showed median overall survival times (OS) of
33.4 vs. 30.4 months (p= 0.49, HR 0.87, 95% CI 0.59-1.29, ITT) in favor of
tasquinimod, longer than previously reported in this metastatic prostate cancer
population. A stronger trend for survival benefit is observed in patients with
bone metastases; median OS was 34.2 vs. 27.1 months (p=0.19, HR 0.73, 95% CI
0.46-1.17). This phase II clinical trial was designed to test the safety and
efficacy of tasquinimod. Noteworthy, 41 (61%) patients crossed-over from placebo
to tasquinimod (mean time to cross-over approx. 5 months). Also, there were
imbalances in baseline prognostic factor in favor of the placebo arm. These were
addressed with a multivariate analysis of known CRPC prognostic factors. It
demonstrated a statistically significant OS advantage for tasquinimod treated
patients with a hazard ratio (HR) of 0.64 (95% CI 0.42-0.97, p=0.034), a
decrease of approximately 40% in the instantaneous risk of event (death),
accompanied by improvement in progression-free survival (HR 0.52, 95% CI
0.35-0.78, p=0.001).
"Men with metastatic CRPC in this trial were unexpectedly found to have
prolonged survival times beyond that previously reported in this patient
population, despite a high fraction of patients with liver and lung metastases."
says principal author Andrew Armstrong, MD ScM, Assistant Professor of Medicine
and Surgery at Duke University and the Duke Prostate Center. "We also found that
despite initial imbalances in baseline characteristics, the improvements in
progression-free survival with tasquinimod may translate into improvements in
overall survival, and, if confirmed in the ongoing phase 3 trial, suggests that
tasquinimod may have an important role in the future treatment of men with
CRPC."
Tomas Leanderson, President and CEO of Active Biotech, said: "These data further
increase our strong confidence in tasquinimod as a valuable asset to address the
huge medical need for hundreds of thousands of men with limited treatment
options today".
Claude Bertrand, Executive Vice-President R&D, Chief Scientific Officer of Ipsen
said: "We are thrilled with Tasquinimod's phase II results as they underline the
activity of the compound. With its differentiated mechanism of action, we look
forward to completing the ongoing phase III and replicating these interesting
results to propose an alternative treatment that does not target the androgen
receptor pathway to progressing patients."
For more detailed information, please see www.asco.org. The presentation is
available on Active Biotech's web site www.activebiotech.com.
* A.J. Armstrong, M. Häggman, W.M. Stadler, J.R. Gingrich, V.J. Assikis, J.
Polikoff, S.R. Denmeade, D.J. George, C. Andreou, W.R. Clark, P. Sieber, R.
Agajanian, L. Belkoff, J-E. Damber, Ö. Nordle, G. Forsberg, M. A. Carducci, 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 Phase II
A global, pivotal, 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, 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<0.0001).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.
About 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 with approximately 600
patients recruited so far. Top line results expected by the end of 2013.
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. Further projects in clinical development
comprise the two orally administered compounds, 57-57 for Systemic Sclerosis and
RhuDex(®) for rheumatoid arthritis. 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 ?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 2011, R&D expenditure totaled more than ?250 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.
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.
For further information:
Active Biotech
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
tomas.leanderson(at)activebiotech.com
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
Ipsen
Media
Didier Véron
Vice President, 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(at)ipsen.com
Financial Community
Pierre Kemula Stéphane Durant des Aulnois
Vice President, Investor Investor Relations Manager
Relations Tel.: +33 (0)1 58 33 60 09
Tel.: +33 (0)1 58 33 60 08 Fax: +33 (0)1 58 33 50 63
Fax: +33 (0)1 58 33 50 63 E-mail: stephane.durant.des.aulnois(at)ipsen.com
E-mail: pierre.kemula(at)ipsen.com
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 3:00 pm. CET on June 4, 2012.
Active Biotech?s and Ipsen?s Tasquinimod shows encouraging OS:
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Source: Active Biotech via Thomson Reuters ONE
[HUG#1617049]
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Datum: 04.06.2012 - 15:00 Uhr
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