HuMaxIL15 Phase III Results 4th September 2002

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HuMax-IL15 Phase I/II Results4th September 2002
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Key Results

• Encouraging short term efficacy
• ACR20 in more than 60 of patients
• ACR70 achieved in all cohorts
• No safety or tolerability issues
• No constraints for continuing into Phase II

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HuMax-IL15 Phase I/II

• Hybrid design of conventional single dose
  escalation
• trial followed by 4 week multiple doses
• Single dose Randomized, double blind, placebo
  controlled trial with 6 cohorts of 5 patients (4
  active and 1 placebo)
• Repeat dose Open label, 4 week multiple doses in
  the same patients (placebo patients continue on
  active treatment)
• Patients with active RA failing DMARD treatment

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Maximal Response at Week 7, 8, 9, 11Repeat Dose
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Safety Issues

• No dose limiting toxicities
• Maximum tolerated dose was not reached
• One serious adverse event (0.15 mg/kg cohort)
• Deterioration of study disease (not related to
  study drug)