Tasquinimod Biomarker Phase II data presented at ESMO 2012
Oct 1, 2012 09:08 (CEST)
Active Biotech AB
Company Announcement
Tasquinimod Biomarker Phase II data presented at ESMO 2012
Lund (Sweden) and Paris (France), October 1, 2012. Active Biotech (NASDAQ OMX
NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) have presented a new set of
data on biomarkers from the previously concluded tasquinimod Phase II study in
chemotherapy-naïve metastatic castrate resistant prostate cancer (CRPC) at the
scientific congress ESMO (European Society for Medical Oncology) held in Vienna
September 28-October 2.
Dr Michael Carducci, Johns Hopkins Medical Institute, Baltimore, US, presented
on Saturday September 29 the poster "Tasquinimod mechanism of action
biomarkers: Correlation with PFS and survival in men with metastatic castrate
resistant prostate cancer treated in a randomized phase 2 trial*".
The purpose of this analysis from the phase II trial was to investigate the
effects of tasquinimod on selected biomarkers to confirm preclinical findings
on the mechanism of action. The results support an effect of tasquinimod on
both immunomodulation and angiogenesis which positions tasquinimod as a
potentially unique therapeutic approach with a mechanism of action that does
not target the androgen receptor pathway.
The findings shall be further validated in the ongoing phase III
placebo-controlled study in men with bone-metastatic CRPC, which has been
adequately powered to detect an OS improvement. The 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 2013.
For more detailed information, please see www.esmo.org. The presentation is
available on Active Biotech's web site www.activebiotech.com.
* M.A. Carducci, A.J. Armstrong, M. Häggman, W.M. Stadler, J.R. Gingrich, V.
Assikis, J. A. Olsson, Ö. Nordle, G. Forsberg, 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 tasquinimod phase II
A global 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 defined as proportion of 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<.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. In June, 2012, overall
survival (OS) data was presented at ASCO (American Society of Clinical
Oncology).
About tasquinimod 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 and top line results
expected by the end of 2013.
About Active Biotech
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, TASQ 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
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.
Ipsen 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
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or undertaking to update or revise any forward looking statements, targets or
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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@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@ipsen.com
Financial Community Stéphane Durant des Aulnois
Pierre Kemula
Vice President, Corporate Finance, Treasury Investor Relations Manager
and Financial Markets 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:
E-mail: pierre.kemula@ipsen.com stephane.durant.des.aulnois@ips
en.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 8:30 a.m. CET on October 1, 2012.