Prostate VTP: Clinical Trial Update

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Presentation transcript:

Prostate VTP: Clinical Trial Update Katie S. Murray, D.O. Urological Oncology April 24, 2015

WST-11 (TOOKAD® SOLUBLE ) Novel Class of photosensitizers derived from Chlorophyll Non-thermal localized treatment effect Water soluble, binds albumin Rapid Clearance (t1/2 = 37 minutes) IV Administration (4 mg/kg) Laser fibers pre-positioned using brachy template Light Activation of WST-11 at 753 nm Patient discharged after 6 hours - WST 11 was developed at the Weizmann Institute by Dr. Avigdor Scherz

Clinical Trial Program TOOKAD® Soluble-WST11 Clinical Trials (Prostate Cancer) PHASE II PHASE III 155 patients: PCM 201: 40 patients (Europe – Canada) PCM 202: 30 patients (United States) PCM203: 85 patients (Europe) PCM 301 - Europe Open label study randomized vs Active Surveillance 400 patients (200 /arm) Recruitment complete (n=413) PCM 304- Latin America Open label single arm study 80 patients Recruitment complete (n=81)

Phase 2 Studies: Trial Endpoints Pathologic Negative biopsy in the treated lobe at Month 6 Serious Adverse Events (SAEs) Graded SAEs, QOL (IPSS, IIEF) Markers Volume of hypoperfusion area shown by MRI at Day 7 Serum PSA levels and PSA changes from baseline at 6 months

Patients treated unilaterally with optimal conditions: TOOKAD® Soluble Phase II Studies Phase 2 Studies Patients treated unilaterally with optimal conditions: 4 mg/kg-200 J/cm Mean % Necrosis* Negative biopsies n (%) PCM 201 8 99.0% 7 (87.5%) PCM 202 15 74.3 % 11 (73.3%) PCM 203 42 90.7% 34 (81.0%) All studies 65 87.6% 52 (80.0%) * Mean % Necrosis = Volume of necrosis/ Vol prostate pre+post treatment/2

TOOKAD® Soluble – Quality of Life Outcomes Erectile Function and Urinary Symptoms 20 15 10 5 Mean IIEF-5 score (max = 25) and Mean IPSS score (max = 35) Mean Score ( IIEF and IPSS) 25 IIEF score IPSS score 15.7 18.8 15.4 13.7 8.5 7.0 5.6 5.4 Baseline Month 1 Month 3 Month 6 (n = 149) (n = 149) (n = 147) (n = 150) 6 6

Perineal pain/Hematoma Urinary tract infection TOOKAD® Soluble - Safety profile Adverse events Adverse events in phase II patients treated with 4 mg/kg N = 117 Dysuria 39 (33.3%) Perineal pain/Hematoma 18 (15.4%) Hematuria 16 (13.7%) Urinary retention 13 (11.1%) Urinary urgency 11 (9.4%) Polyuria 9 (7.7%) Urinary tract infection 7 (6.0%) Prostatitis 5 (4.3%) Hematospermia No Fistulae, No Phototoxicity, No Severe Incontinence

TOOKAD® Soluble Phase II studies Long term Follow-up 123 Patients in post-study follow-up : 95 (77%) patients are still actively followed 24 (20%) patients have undergone further whole gland therapies for prostate cancer, including: 16 Radical prostatectomy 7 Brachytherapy 1 HIFU 4 (3%) patients are lost to follow-up

Summary: Phase II Trials Focal Treatment with WST-11 VTP Feasible and Safe for Hemiablation and Bilateral Tx Efficacy Approx. 80% in treated site (by biopsy) Retreatment also suggests ≈ 80% efficacy Well Tolerated Urinary Function Erectile Function Adverse Events Results of Phase 3 studies anticipated Long Term Outcomes are pending (48 mos)