Clinical Trials

Summary of Phase I Clinical Trial for Hip Repair

12 Subjects: 11 females, 1 male
Patient age: 72 – 91 years
Hip prosthesis age: 9 – 26 years
All subjects were suffering from significant chronic pain and greatly reduced mobility, and all were suffering from comorbidities that precluded them from revision surgery. The clinical trial was a vector dose escalating study, where all subjects received both the complete GDEPT therapy and the hip re-cementation. The clinical trial demonstrated  good safety outcomes, and importantly improvements in pain and walking ability.

Reference: de Poorter et al, Human Gene Ther. 2008, vol 19, pp 83-95 and vol 19 pp1029-1038

Summary of completed Clinical Trials

The following clinical trial work has been completed for CTL102/CB1954:
  • Phase I safety of prodrug CB1954 in 30 cancer patients, dose limiting toxicity and pharmacokinetics
  • Phase I safety and tolerability study of vector CTL102 in 18 cancer patients
  • Phase I safety study in 24 liver cancer patients, with four subjects receiving complete GDEPT therapy (CTL102 + CB1954)
  • Phase I/II safety and efficacy study in 39 prostate cancer patients
  • Phase I clinical study to assess safety, pain and mobility in 12 patients suffering from aseptic loosening (described above)

Safety Summary

  • CTL102 only: >50 subjects
  • CB1954 only: 30 subjects
  • CTL102 + CB1954: 36 subjects