Photocure Asa · OSL:PHO
Photocure Asa — Technical Presentation (December 2012)
9 slides from Photocure Asa's technical presentation, December 2012
Slide 1: Cevira Phase 2b Clinical Trial 3 Month Results
CEVIRA® Phase 2b Clinical Trial 3 Month Results DECEMBER, 2012
Slide 2: Objective of Cevira Phase 2b study
Objective of Cevira Phase 2b study • To verify feasibility, efficacy and safety of the new Cevira photodynamic treatment in a placebo controlled multicenter Phase 2b study in patients diagnosed with CIN1 or CIN2 – Previous Photocure studies with laser showed excellent efficacy and safety signals in
Slide 3: Main Study Metrics
Main Study Metrics • Enrolled 262 patients (average age 29 years) with local histology confirmed CIN1 or CIN2 (safety population) Placebo • 191 patients with CIN 1 and 2 verified by N=68 central blinded review (efficacy population) HAL 0.2% 262 patients N=62 • 128 CIN1/2 patients with positive HPV D
Slide 4: Clinical Trial End Points
Clinical Trial End Points 4Q 2012 1H 2013 3 months after 6-9 months after two or one one or two PDTs treatment Histology, cytology, HPV Cytology, HPV • Primary efficacy /overall • Secondary efficacy response – Cytology – Histology (central review) – HPV DNA genotyping – Cytology – HPV DNA genotyping
Slide 5: Cevira Showed a Significant Efficacy in CIN2 Patients
Cevira Showed a Significant Efficacy in CIN2 Patients Overall response* in CIN2 patients Overall response* in CIN2 HPV positive** (N= 87) patients (N= 72) 100 100 90 90 % responders 80 80 70 70 60 60 50 50 40 40 30 30 20 20 10 10 0 0 HAL 5% HAL 1% HAL 0.2% Placebo HAL 5% HAL 1% HAL 0.2% Placebo p=0.
Slide 6: Cevira Demonstrated a Strong Efficacy in Eradication of HPV16/18
Cevira Demonstrated a Strong Efficacy in Eradication of the Leading Cause of Cervical Cancer (HPV16/18) • Several human papilloma virus (HPV) strains can cause precancerous lesions which lead to cervical cancer HPV CLEARANCE RATE • HPV strain 16 and 18 has the highest risk for causing cancer Cevira*
Slide 7: Tolerability
Tolerability • No serious or systemic treatment related events were reported • Treatment was well tolerated by the patients at all doses – 38% of the patients reported self-limiting local related events (e.g. discharge, discomfort, bleeding) • Five pregnancies reported during study – 4 normal delive
Slide 8: Summary of Initial Results at 3 Months
Summary of Initial Results at 3 Months • Cevira at the optimal dose demonstrated significant efficacy in the CIN2 patients • Significant overall response • Significant clearance of high risk HPV16/18 • Cevira at the optimal dose showed a clear effect in overall response and HPV clearance in the over
Slide 9: Thank you for your attention
Thank you for your attention 9