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DC Bead® is an embolic Drug-Eluting Bead capable of loading and ...
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Clinical Trials for Hepatocellular Carcinoma <strong>DC</strong> <strong>Bead</strong> ® BibliographyBridge to LiverTr<strong>an</strong>spl<strong>an</strong>tDownstage to Resectionor Tr<strong>an</strong>spl<strong>an</strong>tUnsuitable for Liver Tr<strong>an</strong>spl<strong>an</strong>t or ResectionStudy Design Endpoint Status n LocationMulticentre, R<strong>an</strong>dom<strong>is</strong>ed, Phase IISingle-Centre, Phase IISingle-Centre, Phase IISingle-Centre, Phase IISingle-Centre, Phase IIProspective R<strong>an</strong>dom<strong>is</strong>ed Study <strong>of</strong> Tr<strong>an</strong>sarterial Doxorubicin-<strong>Eluting</strong> <strong>Bead</strong> Embol<strong>is</strong>ation vsConventional TACE in the Treatment <strong>of</strong> Patients with Hepatocellular Carcinoma on the Liver Tr<strong>an</strong>spl<strong>an</strong>t Waiting L<strong>is</strong>tProspective, Single-Arm, Phase I/IIInternational Multicentre, Prospective,R<strong>an</strong>dom<strong>is</strong>ed, Single-Blind, Phase IIProspective, Single-Arm, PilotProspective, R<strong>an</strong>dom<strong>is</strong>ed, Single-CentreProspective, Single-Arm, Phase II, PilotInternational Multicentre, R<strong>an</strong>dom<strong>is</strong>ed,Double-Blind, Phase IIH<strong>is</strong>tological Response<strong>an</strong>d Tr<strong>an</strong>spl<strong>an</strong>tabilityH<strong>is</strong>tological Response<strong>an</strong>d Tr<strong>an</strong>spl<strong>an</strong>tabilityH<strong>is</strong>tological Response<strong>an</strong>d ResectabilityDownstage to Tr<strong>an</strong>spl<strong>an</strong>tSafety, Efficacy <strong>an</strong>dPharmacokinetics(Dose Escalation)Phase I: Dose EscalationPhase II: Safety <strong>an</strong>d EfficacySafety <strong>an</strong>d EfficacySafety <strong>an</strong>d EfficacyEfficacy, Safety, Time toProgression <strong>an</strong>d SurvivalEfficacy, Safety, Feasibility,Progression-Free Survival<strong>an</strong>d Overall SurvivalTime to UntreatableProgressionRecruiting 88Assessment <strong>of</strong> Chemoembol<strong>is</strong>ation using Doxorubicin-<strong>Eluting</strong> <strong>Bead</strong>s in Patients L<strong>is</strong>ted forOrthotopic Liver Tr<strong>an</strong>spl<strong>an</strong>tation with Hepatocellular Carcinoma with Expl<strong>an</strong>t CorrelationRecruiting 20LC <strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong> for Treatment <strong>of</strong> Liver C<strong>an</strong>cer Which C<strong>an</strong>not be Surgically Removed (HCC)Recruiting 18A Pilot Study <strong>of</strong> Neoadjuv<strong>an</strong>t Therapy for Hepatocellular Carcinoma using Doxorubicin-<strong>Eluting</strong> Embolic <strong>Bead</strong>sChemoembolization <strong>of</strong> Hepatocellular Carcinoma with <strong>Drug</strong>-<strong>Eluting</strong><strong>Bead</strong>s: Efficacy <strong>an</strong>d Doxorubicin Pharmacokinetics (PRECISION I)Recruiting 20Publ<strong>is</strong>hed: Varela M, Real MI, Burrel M et al:Journal <strong>of</strong> Hepatology 46 (2007) 474-481A Phase I/II Trial <strong>of</strong> Chemoembolization for Hepatocellular Carcinomausing a Novel Intra-arterial <strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong> (PRECISION II)Publ<strong>is</strong>hed: Poon R, Tso W, P<strong>an</strong>g R et al:Journal Clinical Gastroenterology <strong>an</strong>dHepatology 5 (2007) 1100-1108Prospective R<strong>an</strong>dom<strong>is</strong>ed Study <strong>of</strong> Doxorubicin in the Treatment <strong>of</strong> HepatocellularCarcinoma by <strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong> Embol<strong>is</strong>ation (PRECISION V)Publ<strong>is</strong>hed: Lammer J, Malagari K, Vogl T et al:Cardiovasc Intervent Radiol 33 (2010) 41-52 1 212Doxorubicin-eluting <strong>Bead</strong>-enh<strong>an</strong>ced Radi<strong>of</strong>requency Ablation<strong>of</strong> Hepatocellular Carcinoma: a Pilot Clinical StudyPubl<strong>is</strong>hed: Lencioni R, Crocetti L, Petruzzi P et al:Journal <strong>of</strong> Hepatology 49 (2008) 217-222Prospective R<strong>an</strong>domized Compar<strong>is</strong>on <strong>of</strong> Chemoembolization with Doxorubicin-<strong>Eluting</strong> <strong>Bead</strong>s<strong>an</strong>d Bl<strong>an</strong>d Embolization with <strong>Bead</strong>Block for Hepatocellular CarcinomaPubl<strong>is</strong>hed: Malagari K, Pomoni M, Kelek<strong>is</strong> et al:Cardiovasc Intervent Radiol 33(2010) 541-551Single Centre Phase II Trial <strong>of</strong> Tr<strong>an</strong>sarterial Chemoembolization with <strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong>sfor Patients with Unresectable Hepatocellular CarcinomaPubl<strong>is</strong>hed: Reyes D, Vossen J, Geschwind J etal: The C<strong>an</strong>cer Journal 15 (2009) 526-532A Phase II R<strong>an</strong>domized, Double-blind, Placebo-controlled Study <strong>of</strong> Sorafenib or Placebo in Combination With Tr<strong>an</strong>sarterialChemoembolization (TACE) Performed With <strong>DC</strong> <strong>Bead</strong> <strong>an</strong>d Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC)2735204120Recruiting 300Germ<strong>an</strong>yNew Zeal<strong>an</strong>dUSAUSASpainHong KongInternationalMulticentreItalyGreeceUSAInternationalMulticentreBridge to LiverTr<strong>an</strong>spl<strong>an</strong>tDownstage to Resectionor Tr<strong>an</strong>spl<strong>an</strong>tUnsuitable for Liver Tr<strong>an</strong>spl<strong>an</strong>t or ResectionTr<strong>an</strong>s-arterial Chemoembolization(TACE) <strong>of</strong> Liver Metastases fromColorectal C<strong>an</strong>cer Using Irinotec<strong>an</strong>-<strong>Eluting</strong> <strong>Bead</strong>s: Preliminary Results.Aliberti C, Tilli M, Benea G & Fiorentini GAntic<strong>an</strong>cer Research 26 (2006): 3793-3796Reprinted from Antic<strong>an</strong>cer Research 26, with perm<strong>is</strong>sion from the Antic<strong>an</strong>cer Research Institute.A Phase I/II Trial <strong>of</strong> Chemoembolizationfor Hepatocellular Carcinoma Using aNovel Intra-Arterial <strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong>.Poon RTP, Tso WK, P<strong>an</strong>g RWC et al.Clinical Gastroenterology <strong>an</strong>d Hepatology(2007) 5:100-1108Tr<strong>an</strong>scatheter chemoembolization inthe treatment <strong>of</strong> HCC in patients noteligible for curative treatments: mid-termresults <strong>of</strong> doxorubicin-loaded <strong>DC</strong> <strong>Bead</strong>.Malagari K, Alexopoulou E, Chatzimichail K et alAbdominal Imaging 33(5) 2008: 512-9Tr<strong>an</strong>sarterial Chemoembolization<strong>of</strong> Liver Metastases from WellDifferentiated Gastroenterop<strong>an</strong>creaticEndocrine Tumors with Doxorubicineluting<strong>Bead</strong>s: Preliminary Results.de Baere T, Deschamps F, Teriitheau C et alJ Vasc Interv Radiol 19 (2008): 855-861<strong>Drug</strong>-eluting bead therapyin primary <strong>an</strong>d metastaticd<strong>is</strong>ease <strong>of</strong> the liver.Carter S <strong>an</strong>d Martin RCGHPB 11 (2009): 541-550Reproduced with perm<strong>is</strong>sion <strong>of</strong> John Wiley & Sons Ltd.Single-Center Phase II Trial <strong>of</strong> Tr<strong>an</strong>sarterialChemoembolization with <strong>Drug</strong>-<strong>Eluting</strong><strong>Bead</strong>s for Patients with UnresectableHepatocellular Carcinoma. InitialExperience in the United States.Reyes D, Vossen J, Geschwind J et alThe C<strong>an</strong>cer Journal 15 (2009): 526-532Surgical downstaging <strong>an</strong>d neo-adjuv<strong>an</strong>ttherapy in metastatic colorectal carcinomawith irinotec<strong>an</strong> drug-eluting beads: a multiinstitutionalstudy.Bower M, Metzger T, Robbins K et alHPB 12 (2010) 31-36Reproduced with perm<strong>is</strong>sion <strong>of</strong> John Wiley & Sons Ltd.Tr<strong>an</strong>sarterial Chemoembolizationwith Epirubicin-eluting <strong>Bead</strong>s versusTr<strong>an</strong>sarterial Embolization beforeLiver Tr<strong>an</strong>spl<strong>an</strong>tation forHepatocellular Carcinoma.Nicolini A, Martinetti L, Crespi S et alJ Vasc Interv Radiol 21 (2010): 327-332Chemoembolization <strong>of</strong> hepatocellularcarcinoma with drug eluting beads: Efficacy<strong>an</strong>d doxorubicin pharmacokinetics.Varela M, Real MI, Burrel M et alJournal <strong>of</strong> Hepatology 46 (2007): 474-481Irinotec<strong>an</strong> drug eluting beadsfor use in chemoembolization:In vitro <strong>an</strong>d in vivo evaluation<strong>of</strong> drug release properties.Taylor RR, T<strong>an</strong>g Y, Gonzalez MV et alEurope<strong>an</strong> Journal <strong>of</strong> PharmaceuticalSciences 30 (2007): 7-14Reprinted from Europe<strong>an</strong> Journal <strong>of</strong> Pharmaceutical Sciences 30, with perm<strong>is</strong>sion from Elsevier.<strong>Drug</strong>-Loaded Microspheres for theTreatment <strong>of</strong> Liver C<strong>an</strong>cer: Review<strong>of</strong> Current Results.Kettenbach J, Stadler A, v<strong>an</strong> Katzler I et al(J Lammer)Cardiovasc Intervent Radiol 31 (2008): 468-476Doxorubicin-eluting beadenh<strong>an</strong>cedradi<strong>of</strong>requencyablation <strong>of</strong> hepatocellularcarcinoma: A pilot clinical study.Lencioni R, Crocetti L, Petruzzi P et alJournal <strong>of</strong> Hepatology 49 (2008): 217-222Tr<strong>an</strong>sarterial chemoembol<strong>is</strong>ation (TACE)using irinotec<strong>an</strong>-loaded beads for thetreatment <strong>of</strong> unresectable metastasesto the liver in patients with colorectalc<strong>an</strong>cer: <strong>an</strong> interim report.Martin RCG, Robbins K, Tomalty D et alWorld Journal <strong>of</strong> Surgical Oncology (2009) 7:80Prospective R<strong>an</strong>domized Study <strong>of</strong>Doxorubicin-<strong>Eluting</strong>-<strong>Bead</strong> Embolization inthe Treatment <strong>of</strong> Hepatocellular Carcinoma:Results <strong>of</strong> the PRECISION V Study.Lammer J, Malagari K, Vogl T et alCardiovasc Intervent Radiol 33 (2010): 41-52Prognostic factors for survival inpatients with unresectable hepatocellularcarcinoma undergoing chemoembolizationwith doxorubicin drug-eluting beads:a preliminary study.Dh<strong>an</strong>asekar<strong>an</strong> R, Kooby D, Staley C et al(Kim H) HPB 12(3) 2010: 174-180Reproduced with perm<strong>is</strong>sion <strong>of</strong> John Wiley & Sons Ltd.Biocompatibles UK LtdTel: +44 (0) 1252 732 732Fax: +44 (0) 1252 732 777email: marketing@biocompatibles.comwww.biocompatibles.comLabelColourYellowBlueRedNominal<strong>Bead</strong> Size100 - 300µm300 - 500µm500 - 700µmIntraarterial HepaticChemoembolization <strong>of</strong> LiverMetastases from Colorectal C<strong>an</strong>cerAdopting Irinotec<strong>an</strong>-eluting <strong>Bead</strong>s:Results <strong>of</strong> a Phase II Clinical Study.Fiorentini G, Aliberti C, Turr<strong>is</strong>i G et alIn vivo 21 (2007): 1085-1092Tr<strong>an</strong>sarterial Chemoembolization<strong>of</strong> Unresectable Hepatocellular Carcinomawith <strong>Drug</strong> <strong>Eluting</strong> <strong>Bead</strong>s: Results <strong>of</strong> <strong>an</strong>Open-Label Study <strong>of</strong> 62 Patients.Malagari K, Chatzimichael K, Alexopoulou E et alCardiovasc intervent Radiol 31 (2008): 269-280Chemoembolization (TACE) <strong>of</strong> UnresectableIntrahepatic Chol<strong>an</strong>giocarcinoma withSlow-Release Doxorubicin-<strong>Eluting</strong> <strong>Bead</strong>s:Preliminary Results.Aliberti C, Benea G, Tilli M et alCardiovasc Intervent Radiol 31 (2008): 883-888Prospective R<strong>an</strong>domized Compar<strong>is</strong>on <strong>of</strong>Chemoembolization with Doxorubicin-<strong>Eluting</strong> <strong>Bead</strong>s <strong>an</strong>d Bl<strong>an</strong>d Embolizationwith <strong>Bead</strong>Block for HepatocellularCarcinoma.Malagari K, Pomoni M, Kelek<strong>is</strong> A et al.Cardiovasc Interv Radiol 33 (2010): 541-551Tr<strong>an</strong>sarterial Chemoembolization <strong>of</strong>Metastatic Colorectal Carcinoma with<strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong>s, Irinotec<strong>an</strong> (DEBIRI):Multi-Institutional Reg<strong>is</strong>try.Martin RCG, Joshi J, Robbins K et alJournal <strong>of</strong> Oncology (2009) Article ID 539795doi:10.1155/2009/539795Stability <strong>of</strong> irinotec<strong>an</strong>-loadeddrug eluting beads (<strong>DC</strong> <strong>Bead</strong> ) usedfor tr<strong>an</strong>sarterial chemoembolization.Ka<strong>is</strong>er J, Thiesen J & Krämer IJ Oncol Pharm Practice 16 (2010): 53-61Compar<strong>is</strong>on <strong>of</strong> Conventional Tr<strong>an</strong>sarterialChemoembolization (TACE) <strong>an</strong>dChemoembolization with Doxorubicin<strong>Drug</strong> <strong>Eluting</strong> <strong>Bead</strong>s (DEB) forUnresectable Hepatocellular Carcinoma.Dh<strong>an</strong>asekar<strong>an</strong> R, Kooby D, Staley C et alJ <strong>of</strong> Surg Onc 101 (2010): 476-480Volume<strong>of</strong> <strong>Bead</strong>s2ml2ml2mlProductCode<strong>DC</strong>2V103<strong>DC</strong>2V305<strong>DC</strong>2V507The products may not be available for sale, may not be reg<strong>is</strong>tered, approved or cleared for use as claimed, in all countries where Biocompatibles <strong>is</strong> represented.<strong>DC</strong> <strong>Bead</strong> ® <strong>is</strong> <strong>an</strong> <strong>embolic</strong> <strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong><strong>capable</strong> <strong>of</strong> <strong>loading</strong> <strong>an</strong>d releasing in acontrolled m<strong>an</strong>ner chemotherapeutic agents<strong>DC</strong> <strong>Bead</strong> <strong>is</strong> CE-Mark approved for <strong>loading</strong> withdoxorubicin (DEBDOX ) <strong>an</strong>d irinotec<strong>an</strong> (DEBIRI )DEBDOX(<strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong> doxorubicin)<strong>DC</strong> <strong>Bead</strong> <strong>is</strong> intended to be loadedwith doxorubicin for the purpose <strong>of</strong>:• Embol<strong>is</strong>ation <strong>of</strong> vesselssupplying malign<strong>an</strong>thypervascular<strong>is</strong>ed tumour(s)• Delivery <strong>of</strong> a local, controlled,sustained dose <strong>of</strong> doxorubicinto the tumour(s)DEBIRI(<strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong> irinotec<strong>an</strong>)<strong>DC</strong> <strong>Bead</strong> <strong>is</strong> intended to be loadedwith irinotec<strong>an</strong> for the purpose <strong>of</strong>:• Embol<strong>is</strong>ation <strong>of</strong> vessels supplyingmalign<strong>an</strong>t colorectal c<strong>an</strong>cermetastas<strong>is</strong>ed to the liver (mCRC)• <strong>Eluting</strong> a local, controlled, sustaineddose <strong>of</strong> irinotec<strong>an</strong> to hepaticmetastases <strong>of</strong> colorectal c<strong>an</strong>cerwww.biocompatibles.com<strong>DC</strong> <strong>Bead</strong> <strong>is</strong> not currently available for sale or d<strong>is</strong>tribution in the USA. <strong>DC</strong> <strong>Bead</strong> <strong>is</strong>a reg<strong>is</strong>tered trademark <strong>an</strong>d LC <strong>Bead</strong>, DEBIRI <strong>an</strong>d DEBDOX are trademarks <strong>of</strong>Biocompatibles UK Ltd. © 2010 Biocompatibles UK Limited. EC10-096 Rev 2.
Biocompatibles’ Hepatocellular Carcinoma Clinical ProgrammeSuitable for Liver Tr<strong>an</strong>spl<strong>an</strong>tUnsuitable for LiverTr<strong>an</strong>spl<strong>an</strong>t or ResectionReduceCardiac R<strong>is</strong>kProtectHealthy LiverMinim<strong>is</strong>eAlopeciaTrials for Hepatic MetastasesDesign Endpoint Regimen Status n Location<strong>Drug</strong>-<strong>Eluting</strong> <strong>Bead</strong>, Irinotec<strong>an</strong> (DEBIRI) Therapy <strong>of</strong> Liver Metastases from Colon C<strong>an</strong>cer with Concomit<strong>an</strong>tSystemic Oxaliplatin, Fluorouracil <strong>an</strong>d Leucovorin Chemotherapy, <strong>an</strong>d Anti-Angiogenic TherapyWaiting ontr<strong>an</strong>spl<strong>an</strong>t l<strong>is</strong>tFeasibility phase: 10 patients (complete)R<strong>an</strong>dom<strong>is</strong>ed phase: 60 patientsSafetyEfficacyFOLFOX + Avastin (IV) vsFOLFOX + Avastin + DEBIRIRecruiting 70 USAC<strong>an</strong> bedownstagedUnsuitablefor resectionSuitable for locoregionaltherapySchemaWeek 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7FOLFOX LC <strong>Bead</strong> FOLFOX LC <strong>Bead</strong> FOLFOX Break FOLFOX+ Avastin 100mg +Avastin 100mg + Avastin + AvastinIrinotec<strong>an</strong>Irinotec<strong>an</strong>• Then repeat CT to evaluate initial responseResponse Rates <strong>an</strong>d Pharmacokinetics to Date• 3 <strong>an</strong>d 6-month response rate: 100% (2 CR, 8 PR)Surgical Downstaging• 5 (50%) patients downstaged to resection• All tolerated surgical resection• Pathologic response rates >90%Chemoembol<strong>is</strong>ation with Irinotec<strong>an</strong>-Loaded <strong>DC</strong> <strong>Bead</strong> ® (DEBIRI) in Combination with Cetuximab in theFirst-line Treatment <strong>of</strong> Patients with KRAS Wild-type Metastatic Colorectal C<strong>an</strong>cer (mCRC)Bridge totr<strong>an</strong>spl<strong>an</strong>tTr<strong>an</strong>spl<strong>an</strong>tDownstageto tr<strong>an</strong>spl<strong>an</strong>tTr<strong>an</strong>spl<strong>an</strong>tDownstageto resectionResectionSuitable for TACEwith <strong>DC</strong> <strong>Bead</strong>RFA ±Downstaged?BorderlineRFA ≥5cmReassess for tr<strong>an</strong>spl<strong>an</strong>t,resection or ablationThe <strong>DC</strong> <strong>Bead</strong> ® clinical programme targets treatment <strong>of</strong> a wider<strong>an</strong>ge <strong>of</strong> HCC patients by using the products alone <strong>an</strong>d incombination with surgery <strong>an</strong>d other treatment modalities+ d<strong>is</strong>easemodifyingdrugsProtect your patients. Improve response.Patients with HCC receiving PRECISION TACE with <strong>DC</strong> <strong>Bead</strong> ® ,experience less toxicity with improved response, compared tothose receiving conventional chemoembol<strong>is</strong>ation 1,2,3,4Results from the PRECISION V clinical trial 1✔ Reduce Cardiac R<strong>is</strong>k<strong>DC</strong> <strong>Bead</strong> patients had maintained or improved cardiac functioncompared to those receiving conventional chemoembol<strong>is</strong>ation. 1✔ Improve Response<strong>DC</strong> <strong>Bead</strong> patients with more adv<strong>an</strong>ced d<strong>is</strong>ease showed a signific<strong>an</strong>t1improvement in response (p
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