title: An intra-patient placebo-controlled phase I trial to evaluate the safety and tolerability of intradermal IMM-101 in melanoma.
abstract: BACKGROUND
  IMM-101 is a heat-killed innate and adaptive immune-activating mycobacterial product; a phase I study aimed to determine its safety and tolerability in individuals with melanoma.
  
  
  METHODS
  An intra-patient placebo-controlled study evaluated the safety and tolerability of three doses, namely, 0.1 (1 mg/ml), 0.5 (5 mg/ml) and 1.0 mg (10 mg/ml) of IMM-101 in stage III or IV melanoma. Each dose was administered in ascending order to one of the three cohorts.
  
  
  RESULTS
  Based on observations from patients administered the 0.1-mg dose, it was considered appropriate to proceed with dosing the patients in the 0.5-mg dose cohort and then the 1.0-mg cohort (n = 6 per cohort). Treatment-emergent adverse events that would be considered typical of a post-vaccination state (including joint pains/aches, headaches and influenza-like symptoms) occurred at all dose levels, along with injection site reactions. These were mainly mild in intensity, resolved in a matter of days and responded well to supportive care. During post-study follow-up, two clinical responses (15%) were observed in patients with stage IV disease.
  
  
  CONCLUSIONS
  IMM-101 is safe and well tolerated and there is a rationale for studying IMM-101 at a nominal 1.0-mg dose to complement conventional cytotoxic therapy for patients with advanced cancer.
authors.affiliation: Department of Oncology, Imperial College and Imperial College Healthcare NHS Trust, London. Electronic address: j.stebbing@imperial.ac.uk.
authors.forename: J
authors.initials: J
authors.lastname: Stebbing
authors.affiliation: Department of Oncology, St George's University of London, London.
authors.forename: A
authors.initials: A
authors.lastname: Dalgleish
authors.affiliation: HCA International, London.
authors.forename: A
authors.initials: A
authors.lastname: Gifford-Moore
authors.affiliation: HCA International, London.
authors.forename: A
authors.initials: A
authors.lastname: Martin
authors.affiliation: Immodulon Therapeutics Limited, London.
authors.forename: C
authors.initials: C
authors.lastname: Gleeson
authors.affiliation: Immodulon Therapeutics Limited, London.
authors.forename: G
authors.initials: G
authors.lastname: Wilson
authors.affiliation: Immodulon Therapeutics Limited, London.
authors.forename: L R
authors.initials: LR
authors.lastname: Brunet
authors.affiliation: Immodulon Therapeutics Limited, London.
authors.forename: J
authors.initials: J
authors.lastname: Grange
authors.affiliation: Immodulon Therapeutics Limited, London; Department of Surgery, St George's University of London, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Mudan
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000009:adverse effects; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects; D007271:Injections, Intradermal; D008297:Male; D008545:Melanoma / Q000276:immunology / Q000628:therapy*; D008875:Middle Aged; D008954:Models, Biological; D009161:Mycobacterium / Q000276:immunology; D010919:Placebos; D012878:Skin Neoplasms / Q000276:immunology / Q000628:therapy*
chemical_list: D000970:Antineoplastic Agents; D001428:Bacterial Vaccines; D019496:Cancer Vaccines; D010919:Placebos; C574749:IMM-101