Primary endpoint reached in Active Biotech's TASQ Phase II clinical
trial in prostate cancer patient
(Thomson Reuters ONE) - Lund, Sweden, December 14, 2009 - A first analysis of the primaryendpoint based on data from at least six months' treatment of morethan 200 patients, has been performed in Active Biotech AB's (NASDAQOMX Nordic: ACTI) ongoing Phase II clinical study of TASQ, inpatients with asymptomatic, castrate resistant, metastatic prostatecancer.In this analysis, safety, efficacy and certain biomarkers wereevaluated. The primary endpoint, to show a difference in the numberof patients with disease progression at six months, was reached. Thefraction of patients with disease progression during the six monthperiod was43 % for patients treated with TASQ compared to 67 % for placebotreated patients. The median progression free survival was 24.7 weeksfor the TASQ group, compared to 12.9 weeks (p=0.0001) for theplacebo group. TASQ treatment also had a positive effect on severalbiomarkers relevant for prostate cancer progression and was generallywell tolerated. No safety concerns significantly affecting therisk/benefit ratio for TASQ were identified."This is a very important milestone for TASQ and Active Biotech. I amlooking forward to the further development of this novel,non-cytotoxic treatment. ", says Professor Tomas Leanderson, CEOActive Biotech ".The top line data are based on the local review of diseaseprogression and an additional central review is currently ongoing.Complete results from the trial including additional details and datafrom the central review will be presented at an upcoming scientificconference and in scientific publications.Lund, December 14, 2009Active Biotech AB (publ)Tomas LeandersonPresident and CEOFor further information, please contact:Göran ForsbergVP Investor Relations & Business DevelopmentTel +46 (0)46-19 11 54goran.forsberg(at)activebiotech.comTo editorsAbout TASQThe development of TASQ is primarily focused on the treatment ofprostate cancer. TASQ is a small molecule from the quinoline familyof compounds that binds to the target molecule S100A9. TASQ hasanti-angiogenic properties, meaning that it cuts off the supply ofnutrients to the tumor but it does not belong to the most frequentlyoccurring group of tyrosine kinase inhibitors. The dosing is onetablet a day.Results from a Phase I trial of TASQ were recently published in theBritish Journal of Cancer, where TASQ was studied in patients withcastrate resistant prostate cancer. The results showed that long-termcontinuous oral administration of TASQ seems to be safe and that TASQmight delay disease progression.About the Phase II trialThe reported clinical trial is a 2:1 randomized, placebo controlled,double-blind Phase II trial investigating 1 mg/day of TASQ(tasquinimod, ABR-215050) versus placebo in 206 asymptomatic patientswith metastatic, castrate resistant, prostate cancer. The trial isconducted in the US, Canada and Sweden under an IND (InvestigationalNew Drug) application.The primary endpoint of the Phase II trial is to measure theproportion of patients that display disease progression after sixmonths of TASQ therapy compared with placebo. For more detailedinformation please see http://clinicaltrials.gov. Secondary clinicalendpoints of importance for this group of patients includeprogression free survival, safety and effects on biomarkers.Documentation of such endpoints is of importance for future TASQdevelopment and registration.About Active BiotechActive Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnologycompany with focus on autoimmune/inflammatory diseases and cancer.Projects in pivotal phase are laquinimod, an orally administeredsmall molecule with unique immunomodulatory properties for thetreatment of multiple sclerosis, as well as ANYARA for use in cancertargeted therapy, primarily of renal cancer. Further key projects inclinical development comprise the three orally administered compoundsTASQ for prostate cancer, 57-57 for SLE and RhuDex(TM) for RA. Pleasevisit www.activebiotech.com for more information.Active Biotech is obligated to publish the information contained inthis press release in accordance with the Swedish Securities MarketAct. This information was provided to the media for publication onDecember 14, 2009 at 08:30 a.m.Active Biotech ABPO Box 724, SE-220 07 LundSwedenTel: +46 (0)46-19 20 00Fax: +46 (0)46-19 11 00www.activebiotech.comhttp://hugin.info/1002/R/1360883/332242.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 14.12.2009 - 08:31 Uhr
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