Clinical Programs
Core Therapeutic Programs
Voclosporin - Psoriasis
- An independent data monitoring committee (DMC) conducted a review of the blinded Phase 3 psoriasis trial (ESSENCE) safety and efficacy data. The DMC did not raise any concerns that would require a change to the original study design.
- Recruitment for ESSENCE was closed at 642 patients on July 20, 2007
- First patient enrolled in ESSENCE on December 5, 2006
- Successfully completed a Canadian Phase 3 trial for the treatment of moderate to severe psoriasis
Voclosporin - Kidney
- Successful completion of PROMISE trial announced May 27, 2008
- Last patient enrolled in PROMISE completes the trial, announced on January 3, 2008
- FDA allows patients who have already completed 12 months of voclosporin treatment to continue therapy through to commercialization of the drug
- Full enrolment announced on June 27, 2007 (334 patients)
- Health Canada grants a No Objection Letter allowing patients who have already completed 12 months of voclosporin treatment to continue therapy through to commercialization of the drug
- Initial data released November 16, 2006
- First patient enrolled in PROMISE on January 4, 2006
Voclosporin - Uveitis
- FDA grants Fast-Track designation for voclosporin in uveitis
- Lux was granted orphan drug designation from the FDA for voclosporin for the treatment of non-infectious posterior, intermediate, and panuveitis. This designation qualifies Lux for exclusive marketing rights in the United States for seven years if the company is the first to receive marketing approval.
- On November 28, 2006, Lux announced it had received permission from the FDA of the United States to proceed with three separate Phase 2/Phase 3 clinical trials to investigate voclosporin for the treatment of active and control of quiescent non-infectious uveitis.
Voclosporin - Drug-eluting coronary stents
- Atrium commences FIM trial on June 9, 2008
- Atrium receives approval from the Belgian Competent Authority to enter First-in-Man (FIM) trial
- The trial is expected to involve up to 100 patients and will be conducted at seven clinical trial sites in Belgium
TAFA93
- Successful completion of Phase 1 trial was announced on August 21, 2006
Commercialized Diagnostic Products
Helikit®
- 13C breath test developed for the detection of H.pylori, a bacterium that infects a large portion of the population
Last updated June 11, 2008