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Tasquinimod Biomarker Phase II data presented at ESMO 2012

October 1, 2012 - Lund, Sweden And Paris

Active Biotech (NASDAQ OMXNORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) have presented a new setofdata on biomarkers from the previously concluded tasquinimod Phase II studyinchemotherapy-naïve metastatic castrate resistant prostate cancer (CRPC)at thescientific congress ESMO (European Society for Medical Oncology) held inViennaSeptember 28-October 2.

Dr Michael Carducci, Johns Hopkins Medical Institute, Baltimore, US,presentedon Saturday September 29 the poster "Tasquinimod mechanism of actionbiomarkers:Correlation with PFS and survival in men with metastatic castrateresistantprostate cancer treated in a randomized phase 2 trial*".

The purpose of this analysis from the phase II trial was to investigatetheeffects of tasquinimod on selected biomarkers to confirm preclinical findingsonthe mechanism of action. The results support an effect of tasquinimod onbothimmunomodulation and angiogenesis which positions tasquinimod as apotentiallyunique therapeutic approach with a mechanism of action that does not targettheandrogen receptor pathway.

The findings shall be further validated in the ongoing phase IIIplacebo-controlled study in men with bone-metastatic CRPC, which has beenadequatelypowered to detect an OS improvement. The study will include about 1,200patientsin more than 250 centers. Recruitment is proceeding according to plan withtopline results expected by the end of 2013.

For more detailed information, please see The presentationisavailable on Active Biotech's web site

* 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 includesimmunomodulatory,anti-angiogenic and anti-metastatic activity. Today the developmentoftasquinimod is principally focused on the treatment of prostate cancer. Itwasannounced in December 2009 that the primary endpoint of the Phase IIclinicalstudy, to show a higher fraction of patients with no disease progressionduringthe six-month period of treatment using tasquinimod, had been met. PhaseIIresults were published in Journal of Clinical Oncology in September 2011.

About tasquinimod phase II

A global clinical trial 2:1 randomized, placebo controlled, double-blindPhaseII trial investigating up to 1 mg/day of TASQ versus placebo in 206asymptomaticpatients with metastatic castrate resistant prostate cancer (CRPC). Theprimaryendpoint defined as proportion of patients with disease progression atsixmonths, was reached. The results showed that 6 month progression-freeproportions for TASQ and placebo groups were 69% and 37%,respectively(p < .0001). The median progression free survival was 7.6 months for theTASQgroup, compared to 3.3 months for the placebo group (p=0.0042). TASQtreatmentalso had an effect on biomarkers relevant for prostate cancer progressionandwas generally well tolerated. Analysis of up to three years safety data fromthePhase II study, presented at the EAU February 2012, show that treatmentsideeffects were mild to moderate (~ 5% of AEs grade 3-4), manageable andlessfrequent after two months of therapy. The adverse events observedincludedgastrointestinal disorders, primarily observed initially duringtreatment,fatigue and musculoskeletal pain. In June, 2012, overall survival (OS) datawaspresented at ASCO (American Society of Clinical Oncology).

About tasquinimod phase III

A global, pivotal, randomized, double-blind, placebo-controlled Phase IIIstudyof tasquinimod in patients with metastatic CRPC is ongoing. The aim of thestudyis to confirm tasquinimod's efficacy on the disease, withradiologicalProgression Free Survival (PFS) as the primary endpoint and overall survivalassecondary endpoint. The study will include about 1,200 patients in morethan250 clinics. Recruitment is proceeding according to plan and top lineresultsexpected by the end of 2013.

About Active Biotech

Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology companywithfocus on autoimmune/inflammatory diseases and cancer. Projects in orenteringpivotal phase are laquinimod, an orally administered small molecule withuniqueimmunomodulatory properties for the treatment of multiple sclerosis, TASQforprostate cancer as well as ANYARA for use in cancer targeted therapy,primarilyof renal cell cancer. In addition, laquinimod is in Phase II developmentforCrohn's and Lupus. An additional project in clinical development is theorallyadministered compound 57-57 for Systemic Sclerosis. for more information.

Active Biotech's Safe Harbor Statement in Accordance with the SwedishSecuritiesMarket Act

This press release contains certain forward-looking statements. Suchforward-looking statements involve known and unknown risks, uncertaintiesand otherimportant factors that could cause the actual results, performanceorachievements of the company, or industry results, to differ materially fromanyfuture results, performance or achievement implied by the forward-lookingstatements. The company does not undertake any obligation to update orpubliclyrelease any revisions to forward-looking statements to reflectevents,circumstances or changes in expectations after the date of this press release.

About Ipsen

Ipsen is a global specialty-driven pharmaceutical company with totalsalesexceeding EUR1.1 billion in 2011. Ipsen's ambition is to become aleader inspecialty healthcare solutions for targeted debilitating diseases.Itsdevelopment strategy is supported by four franchises: neurology /Dysport®,endocrinology / Somatuline®, uro-oncology / Decapeptyl(®) andhemophilia.Moreover, the Group has an active policy of partnerships. R&D is focusedoninnovative and differentiated technological patient-driven platforms,peptidesand toxins. In 2011, R&D expenditure totaled more than EUR250 million, above21%of Group sales. The Group has total worldwide staff of close to 4,500employees.Ipsen's shares are traded on segment A of Euronext Paris (stock code: IPN,ISINcode: FR0010259150) and eligible to the "Service de RèglementDifféré" ("SRD").The Group is part of the SBF 120 index. Ipsen has implemented a SponsoredLevelI American Depositary Receipt (ADR) program, which trade on the over-the-countermarket in the United States under the symbol IPSEY. For more informationonIpsen, visit

Ipsen Forward Looking Statement

The forward-looking statements, objectives and targets contained hereinarebased on the Group's management strategy, current views and assumptions.Suchstatements involve known and unknown risks and uncertainties that maycauseactual results, performance or events to differ materially fromthoseanticipated herein. All of the above risks could affect the Group'sfutureability to achieve its financial targets, which were set assumingreasonablemacroeconomic conditions based on the information available today.Moreover, the targets described in this document were prepared withouttakinginto account external growth assumptions and potential futureacquisitions,which may alter these parameters. These objectives are based on dataandassumptions regarded as reasonable by the Group. These targets dependonconditions or facts likely to happen in the future, and not exclusivelyonhistorical data. Actual results may depart significantly from thesetargetsgiven the occurrence of certain risks and uncertainties, notably the fact thatapromising product in early development phase or clinical trial may end upneverbeing launched on the market or reaching its commercial targets, notablyforregulatory or competition reasons. The Group must face or might facecompetitionfrom Generics that might translate into loose of market shares.Furthermore, the Research and Development process involves several stageseachof which involve the substantial risk that the Group may fail to achieveitsobjectives and be forced to abandon its efforts with regards to a productinwhich it has invested significant sums. Therefore, the Group cannot becertainthat favorable results obtained during pre-clinical trials will beconfirmedsubsequently during clinical trials, or that the results of clinical trialswillbe sufficient to demonstrate the safe and effective nature of theproductconcerned. The Group also depends on third parties to develop and market someofits products which could potentially generate substantial royalties;thesepartners could behave in such ways which could cause damage to theGroup'sactivities and financial results. The Group expressly disclaims anyobligationor undertaking to update or revise any forward looking statements, targetsorestimates contained in this press release to reflect any change inevents,conditions, assumptions or circumstances on which any such statements arebased,unless so required by applicable law.The Group's business is subject to the risk factors outlined in itsregistrationdocuments filed with the French Autorité des Marchés Financiers.

Active Biotech is obligated to publish the information contained in thispressrelease in accordance with the Swedish Securities Market Act. Thisinformationwas provided to the media for publication 8:30 a.m. CET on October 1, 2012.

Tasquinimod Biomarker Phase II data presented at ESMO 2012:

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Source: Active Biotech via Thomson Reuters ONE


For further information:

Active Biotech

Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
Email Contact

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


Didier Veron

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: Email Contact

Financial Community
Pierre Kemula
Vice President, Corporate Finance, Treasury and Financial Markets
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
E-mail: Email Contact

Stephane Durant des Aulnois
Investor Relations Manager
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