Phase III trial of ASA404 in lung cancer completes patient enrolment
(Thomson Reuters ONE) - 1 September 2009, London, UK, and Cambridge, MA: Antisoma plc (LSE:ASM; USOTC: ATSMY) today announces that the ATTRACT-1 phase III trialof ASA404 in non-small cell lung cancer (NSCLC) has reached itsenrolment target of 1,200 patients. The trial is the single pivotalregistration study for the drug as a first-line treatment forsquamous and non-squamous NSCLC, and is being conducted by Novartis,Antisoma's development and commercialisation partner for ASA404.Glyn Edwards, Antisoma's CEO, said: "Novartis has done an excellentjob in rapidly completing recruitment into this very large trial ofASA404 in lung cancer. We can now be even more confident that theresults will be available in time to support potential marketingapplications in 2011."Primo N. Lara, Professor of Medicine at the University of CaliforniaDavis Cancer Center and U.S. Steering Committee Chair for theATTRACT-1 study, said: "Lung cancer afflicts an enormous number ofpatients worldwide and there is a clear need for new and improvedtreatment options. Phase II trials reported substantial benefits forlung cancer patients receiving ASA404, and I therefore look forwardgreatly to seeing the results of this large and important phase IIItrial."ASA404 is a Tumour-Vascular Disrupting Agent (Tumour-VDA) thatselectively disrupts established tumour vasculature, inhibits tumourblood flow, and causes extensive tumour necrosis.Enquiries:Daniel Elger, VP Marketing & Communications +44 (0)7909 915 068Antisoma plcMark Court/Lisa Baderoon/Rebecca Skye Dietrich +44 (0)20 7466 5000Buchanan CommunicationsBrian Korb +1 646 378 2923The Trout GroupExcept for the historical information presented, certain mattersdiscussed in this announcement are forward looking statements thatare subject to a number of risks and uncertainties that could causeactual results to differ materially from results, performance orachievements expressed or implied by such statements. These risks anduncertainties may be associated with product discovery anddevelopment, including statements regarding the company's clinicaldevelopment programmes, the expected timing of clinical trials andregulatory filings. Such statements are based on management's currentexpectations, but actual results may differ materially.About the ATTRACT-1 studyATTRACT-1 is a pivotal study designed to support applications tomarket ASA404 in previously untreated, advanced NSCLC. It is arandomised, double-blind, placebo-controlled, multicentre phase IIItrial being conducted across the US, EU, Japan and other territories.ATTRACT-1 opened in April 2008 and has enrolled patients with allhistologies, or types, of NSCLC, including squamous and non-squamouscancers. Patients have been randomised 1:1 to receive either ASA404plus chemotherapy (carboplatin/paclitaxel) or a placebo pluschemotherapy (carboplatin/paclitaxel) as a control.The primary endpoint of ATTRACT-1 is overall survival. Key secondaryendpoints are survival in the squamous and non-squamous patientsubgroups. An interim look is expected to be triggered before the endof 2009. Following collation and processing of data, the interim lookwill take place in early 2010. The outcome will be announcedimmediately. The most likely outcome is that the study will continueto completion. No data will be released unless the look indicatesthat the trial should stop because of clear futility or earlyevidence of overwhelming efficacy. Full and final data are expectedto be available in late 2010 or early 2011, in time to supportpotential applications to market the drug in 2011.In addition to the ATTRACT-1 trial in previously untreated NSCLCpatients, Novartis is conducting a separate pivotal study, ATTRACT-2,to evaluate ASA404 in NSCLC patients who have received one previoustreatment.About non-small cell lung cancer (NSCLC)Lung cancer is the biggest cause of cancer death for both men andwomen worldwide, with 1.2 million new cases per year and around920,000 deaths. Around 85-90% of all lung cancer cases are NSCLC.About ASA404ASA404 (vadimezan, formerly known as DMXAA and AS1404) is asmall-molecule Tumour-Vascular Disrupting Agent (Tumour-VDA) whichtargets the blood vessels that nourish tumours. The drug wasdiscovered by Professors Bruce Baguley and William Denny and theirteams at the Auckland Cancer Society Research Centre, University ofAuckland, New Zealand. It was in-licensed by Antisoma from CancerResearch Ventures Limited (now Cancer Research Technology), thedevelopment and commercialisation company of the Cancer ResearchCampaign (now Cancer Research UK), in 2001. Worldwide rights to thedrug were licensed to Novartis AG in April 2007; Antisoma has anoption to co-sell ASA404 with Novartis in the United States. Novartisis conducting phase III studies of ASA404 in NSCLC, and also plans toinvestigate the drug's potential as a treatment for metastatic breastcancer.A randomised phase II trial in patients receiving first-linetreatment for NSCLC showed that addition of ASA404 to carboplatin andpaclitaxel chemotherapy improved survival by 5 months. A second,single-arm, phase II trial also reported positive results with ASA404in the same patient group.About AntisomaAntisoma is a London Stock Exchange-listed biopharmaceutical companythat develops novel products for the treatment of cancer. The Companyhas operations in the UK and the US. Please visitwww.antisoma.com for further information about Antisoma.- END ----END OF MESSAGE---This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 01.09.2009 - 08:02 Uhr
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