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

PHASE II

155 patients:

PCM 201: 40 patients (Europe – Canada)

PCM 202: 30 patients (United States)

PCM203: 85 patients (Europe)

PCM 301 - EuropeOpen label study randomized

vs Active Surveillance

400 patients (200 /arm)Recruitment complete (n=413)

TOOKAD® Soluble-WST11Clinical Trials (Prostate Cancer)

PHASE III

PCM 304- Latin AmericaOpen label single arm study

80 patients

Recruitment complete (n=81)

Clinical Trial Program

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

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 Phase II Studies

Erectile Function and Urinary Symptoms

Baseline Month 1 Month 3 Month 6 (n = 149) (n = 149) (n = 147) (n = 150)

18.8

13.7

15.7

7.0

8.5

5.6 5.4

15.4

20

15

10

5

Mean IIEF-5 score (max = 25) and Mean IPSS score (max = 35) 25

IIEF score

IPSS score

TOOKAD® Soluble – Quality of Life Outcomes

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 5 (4.3%)

TOOKAD® Soluble - Safety profile

No Fistulae, No Phototoxicity, No Severe Incontinence

TOOKAD® Soluble Phase II studies

Long term Follow-up

123 Patients in post-study follow-up :

o 95 (77%) patients are still actively followed

o 24 (20%) patients have undergone further whole gland therapies for prostate cancer, including:

- 16 Radical prostatectomy - 7 Brachytherapy- 1 HIFU

o 4 (3%) patients are lost to follow-up

Summary: Phase II TrialsFocal 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)