Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Bioshares Investor Conference 2014
18 slides from Oncosil Medical's conference presentation, Jul 18, 2014
Slide 1: BioShares Presentation
BioShares Presentation For personal use only July 2014 ASX: OSL DR. NEIL FRAZER CHIEF EXECUTIVE OFFICER & MANAGING DIRECTOR @Dr_Neil_Frazer 1
Slide 2: Important Notice
IMPORTANT NOTICE For personal use only The purpose of the presentation is to provide an update of the business of OncoSil Medical Ltd (ASX:OSL). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. According
Slide 3: OncoSil - Potential Treatment for Pancreatic Cancer
ONCOSIL™ - POTENTIAL TREATMENT FOR PANCREATIC CANCER For personal use only MAJOR UNMET NEED • OncoSil Medical has an implantable nuclear medicine device that has commenced a pivotal study in pancreatic cancer. • Localised radiation therapy is inherently safe, effective and well tolerated, ideal for
Slide 4: About OncoSil
ABOUT ONCOSIL™ For personal use only • Pure beta radiation source (P32) to avoid systemic side effects • Localised radiation therapy using “sticky” microparticles • Carrier particles are inert silicon • Particles are suspended in fluid to allow direct injection into the tumour • Single Injection und
Slide 5: How OncoSil Works
For personal use only HOW ONCOSIL™ WORKS 5
Slide 6: OncoSil Administration
ONCOSIL™ ADMINISTRATION For personal use only Endoscopic ultrasound positions the injection of OncoSil™ in the pancreatic tumour 6
Slide 7: Completed Pilot Study
COMPLETED PILOT STUDY For personal use only RESULTS: 17 locally advanced pancreatic cancer patients Significant tumouricidal activity with a disease control rate of 82% : 4 Partial Responses, 10 Stable disease and 3 Progressive Disease Average reduction in pain of 35%, with a maximum reduction of 69%
Slide 8: Pancreatic Cancer: Major Unmet Clinical Need
PANCREATIC CANCER For personal use only MAJOR UNMET CLINICAL NEED 280,000+ pancreatic cancer incidence yearly world wide (1) Median survival ~8 months and 5 year survival less than 7% Severe abdominal and back pain is a significant complication in patients who develop pancreatic cancer Approximately
Slide 9: Treatment Choices for Most Human Cancers
TREATMENT CHOICES FOR MOST HUMAN CANCERS For personal use only Surgery: Cut out the tumour: - Only possible in 20% of PC patients Chemotherapy: Poison tumour growth Examples: Gemcitabine and Nab-paclitaxel Radiation therapy: Irradiate the body (external beam radiation shown) - 30 days of radiation -
Slide 10: OncoSil Micro Particles
ONCOSIL™ Micro Particles For personal use only OncoSil™ particles compared with a human hair and red blood cells ONCOSIL ™ 30 MICRON PARTICLES STERILE FILL FINISH (GERMANY) Red Cells HUMAN HAIR (SAME SCALE) REACTOR (NETHERLANDS) OncoSil ™ 0 100 200 u I________I________I 10
Slide 11: Medical Device Development
MEDICAL DEVICE DEVELOPMENT For personal use only Differences between drug and device development Drugs require Phase I, II and III clinical studies Expensive, slow and resource intense Typically 10 years to market (from bench) Devices require Pilot and Pivotal studies Faster, fewer patients, no drug
Slide 12: Registration Study: Study Purposes
REGISTRATION STUDY: PANCREATIC CANCER For personal use only STUDY PURPOSES Achievement of registration for OncoSil™ in key global markets Create state-of-the-art publication to influence key opinion leaders in treatment of pancreatic cancer Establish international credibility for OncoSil™ Create net
Slide 13: Registration Study: Study Design
REGISTRATION STUDY: PANCREATIC CANCER For personal use only STUDY DESIGN Randomized open label clinical trial (Gold Standard) Combination of OncoSil™ with standard of care (SOC) (gemcitabine, or gemcitabine plus Abraxane™) versus SOC alone Chemotherapy commenced within four weeks prior to implantati
Slide 14: Registration Study: Inclusion/Exclusion
REGISTRATION STUDY: PANCREATIC CANCER For personal use only STUDY DESIGN (Inclusion/ exclusion) Pancreatic cancer, locally advanced, non-resectable Concomitant chemotherapy (gemcitabine, or gemcitabine plus Abraxane™) Chemotherapy commenced within four weeks prior to implantation, or within three da
Slide 15: Registration Study: Endpoints
REGISTRATION STUDY: PANCREATIC CANCER For personal use only ENDPOINTS PRIMARY: Overall survival (time from randomization to death) SECONDARY: Progression free survival (time to clinical or radiological confirmed progression) Quality of Life (EORTC Scale) Pain (Brief Pain Index, point of time and 24
Slide 16: Registration Study: Challenges
REGISTRATION STUDY: CHALLENGES For personal use only To Boldly Go…… No prior state-of-the art studies to reference Study design for registration is open for discussion Investigator buy-in Global Study design Supply logistics Global coordination Opinion Leaders/ Opinionated Leaders Funding is king ….
Slide 17: Regulatory Strategy
REGULATORY STRATEGY For personal use only PLAN FOR GLOBAL DEVICE REGISTRATION H1 2014 H2 2014 H1 2015 H2 2015 H1 2016 H2 2016 H1 2017 CE MARK OncoSil™ Pivotal study US registration WITH EMA CE Marking EU, Canada and AU sales IDE PMA OncoSil’s global registration strategy is with CE (Conformité Europ
Slide 18: Conclusions
CONCLUSIONS For personal use only Device studies are different to drug studies No requirement for ADME and drug interaction studies Predictable device life No long term safety issues Building on existing technology No change of existing medical practice Strong KOL buy in to technology in this area R