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

2. 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

3. 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 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)

4. 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

5. 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

6. 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 Month Month 6
(n = 149) (n = 149) (n = 147) (n = 150) 6 6

7. 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

8. 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

9. 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)