Updated on 9 August 2012
This trial demonstrated the safety of this approach. The trial concluded that in the angiogenic application of the encapsulated cells by supraselective catheteriszation was shown to be both feasible and safe in humans; encapsulated cells are well tolerated (up to two years) without any evidence of inflammatory or immune reactions; and no major toxicities beyond grade 2 were observed.
In addition to safety, a number of therapeutic benefits of the treatment were documented including improved quality of life in most patients; tumour reductions in 4four patients with nine-out-of-ten 9/10 patients showing stable disease; a dramatic improvement (close to ~100 percent%) in median survival in comparison to a control group as well as to the current gold standard treatment, gemcitabine; and one year survival rates, which is twice-as-high as those for gemcitabine and three times higher than the control group.
Trial 2) Phase I/II clinical trial in dogs patients with spontaneously occurring mammary tumours
Dogs with mammary tumours were given encapsulated cytochrome P450 expressing cells as an injection of 20 capsules per cm3 of tumour volume, followed by four treatments with standard doses of the oxalophosphamide pro-drug cyclophosphamide, which cytochrome P450 can also activate. Cyclophosphamide was chosen as the pro-drug for the dog trial since it is commonly used for treatment of mammary cancer in dogs and breast cancer in humans.
Tumours were measured just before commencement of the treatment and then again eight weeks after treatment. They were then resected and analysed. As in the human pancreatic cancer trials, the capsules were well tolerated, with no major safety issues. Moreover, there was a therapeutic benefit in dogs receiving the encapsulated cells in addition to cyclophosphamide, with clearly greater degrees of tumour shrinkage being observed in these dogs as compared to those receiving cyclophosphamide alone.
One dog that had two tumours, allowed the comparison of the effect of systemic cyclophosphamide treatment alone with that of systemic cyclophosphamide, activated locally by encapsulated cells. The tumour that did not receive capsules was reduced by 14 percent whereas the tumour receiving capsules showed a 70 percent reduction in tumour volume, demonstrating a clear effect of enzyme conversion from the tumour localised capsules .
Both trials confirmed the results of the preclinical animal studies that encapsulated cells can be used as a targeting device for the treatment of solid tumours by increasing therapeutic efficacy. Moreover, when a lower dose of the chemotherapeutic agent is used, as was the case in the phase I/II pancreatic cancer trial, the side effects of conventional chemotherapy are also significantly reduced making the chemotherapy more tolerable.