In addition to offering the Cell-in-a-Box® and Bac-in-a-Box® platform technologies to 3rd parties, SG Austria also is developing a highly innovative, in-house product pipeline.
SG Austria’s most advanced pipeline project is an oncology product designed primarily for the treatment of non-resectable pancreatic cancer. This Cell-in-a-Box® based product (CapCell in the graph below) can also be used to treat a variety of other solid tumours.
Multiple clinical trials have been performed with great success (see example below) and SG Austria is currently gearing-up for further clinical trial, planned to start in 2013.
A large scale cGMP facility for the manufacturing of biomedical grade encapsulated cell productswas previously established, and SG Austria is currently in the process of re-establishing this capability in SE Asia (see manufacturing).
A successful clinical trial using the Cell-in-a-Box® principal:
Use of encapsulated cells for cancer cell therapy from genetically modified cells over-expressing a chemo-activating enzyme. Shown to be safe and efficacious in a phase I/II clinical trial
Product:
A cell based therapeutic consisting of cells genetically modified to overexpress cytochrome P450 encapsulated in biologically inert cellulose sulphate polymers
– one “off the shelf “ product for all patients
Mechanism of Action:
The encapsulated cells are placed, using supraselective catheterisation, into blood vessels leading to the tumour where they locally convert a chemotherapeutic prodrug to its tumour toxic product
Proven Safety in the clinic:
Phase l/II Trial design
- Advanced non-resectable pancreatic cancer
- 14 patients treated
- One dose of 300 microcapsules
- Delivered by catheter into tumour artery
- 1/3 dose chemotherapy
Therapeutic Effect shown through Tumour Reductions:
Overall Results of Clinical Trial:
- Double survival rate over gold standard
- Tumour shrinkage
- Improvement in Quality of Life
- Proven safety record
- No obvious immune or inflammatory response to cells or capsule material
- Recognised by regulatory authorities EMEA, TGA, FDA, HSA
- EMEA previously granted Orphan Drug Status for this product which gave:
- Free Protocol Advice
- “fast track” thro‘ further clinical trial design together with EMEA
- recommended going straight to Phase III trial for market authorization and help in designing the trial
- Up to ten years market exclusivity
Results published in peer-reviewed journals Lancet and Cancer Therapy.
