R&D Development Strategy

R&D Development Strategy

ORIL has discovered a family of plant-based compounds, determined their unique biological mode of anti-cancer action, demonstrated proof-of-principle in anti-cancer activity, and conducted preliminary preclinical and safety testing. Due to the vagary of natural supply of these compounds, ORIL has synthesised the lead candidates in the laboratory, together with the design and synthesis of novel structural analogues.

ORIL plans to advance its compounds along a planned development path to achieve Phase II testing by 2015:

Preclinical Program

Clinical Program

The development strategy is designed to enable fast track of ORIL007 depending on the clinical outcomes from multiple Phase IB studies. Assuming positive outcomes this would (in consultation with FDA) enable pivotal Phase II study and orphan drug status. A summary is provided in the flow diagram below.

clinical dev

In parallel to the clinical and development program are ongoing studies that will underpin the technology and support the patent applications, thereby protecting ORIL’s valuable intellectual property. ORIL’s overall development strategy and timelines are shown below.

Gantt Chart2

Address

Registered Office
Oncology Research International Limited
Level 5, 45 St George Terrace,
Perth WA 6000 Australia