title: Phase I drug and light dose-escalation trial of motexafin lutetium and far red light activation (phototherapy) in subjects with coronary artery disease undergoing percutaneous coronary intervention and stent deployment: procedural and long-term results.
abstract: BACKGROUND
  Motexafin lutetium (MLu; Antrin) is a photosensitizer that is taken up by atherosclerotic plaque and concentrated within macrophages and vascular smooth muscle cells. After photoactivation with far red light, MLu facilitates production of cytotoxic oxygen radicals that mediate apoptosis. We assessed the safety and tolerability of phototherapy (PT) with MLu in patients undergoing percutaneous coronary intervention with stent deployment.
  
  
  RESULTS
  An open-label, phase I, drug and light dose-escalation clinical trial of MLu PT enrolled 80 patients undergoing de novo coronary stent deployment. MLu was administered to 79 patients by intravenous infusion 18 to 24 hours before procedure, and photoactivation was performed after balloon predilatation and before stent deployment. Clinical evaluation, serial quantitative angiography, and intravascular ultrasound were performed periprocedurally and at 6 months follow-up. MLu PT was well tolerated without serious dose-limiting toxicities, and side effects (paresthesia and rash) were minor. No adverse angiographic outcomes were attributed to phototherapy.
  
  
  CONCLUSIONS
  This study demonstrates that coronary MLu PT seems safe, and the maximum well-tolerated MLu dose and range of tolerated light doses were identified. These data can be used in phase II efficacy trials of MLu PT for the treatment of coronary atherosclerosis or vulnerable plaque.
authors.affiliation: The Lindner Center for Research & Education, 2123 Auburn Ave, Suite 424, Cincinnati, Ohio 45219, USA.
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: Arthur M
authors.initials: AM
authors.lastname: Szyniszewski
authors.forename: Dennis
authors.initials: D
authors.lastname: Wahr
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.forename: Daniel I
authors.initials: DI
authors.lastname: Simon
authors.forename: Campbell
authors.initials: C
authors.lastname: Rogers
authors.forename: Paul
authors.initials: P
authors.lastname: Kramer
authors.forename: Wendy
authors.initials: W
authors.lastname: Shear
authors.forename: Alan C
authors.initials: AC
authors.lastname: Yeung
authors.forename: Kendrick A
authors.initials: KA
authors.lastname: Shunk
authors.forename: Tony M
authors.initials: TM
authors.lastname: Chou
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Popma
authors.forename: Peter
authors.initials: P
authors.lastname: Fitzgerald
authors.forename: Tanya E
authors.initials: TE
authors.lastname: Carroll
authors.forename: David
authors.initials: D
authors.lastname: Forer
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Adelman
mesh_terms: D000328:Adult; D015906:Angioplasty, Balloon, Coronary; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004307:Dose-Response Relationship, Radiation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008665:Metalloporphyrins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D010778:Photochemotherapy / Q000009:adverse effects; D017319:Photosensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome
chemical_list: D008665:Metalloporphyrins; D017319:Photosensitizing Agents; C102825:motexafin lutetium