PCI Biotech reported today that it has completed the treatment of the third dose group in the phase I/II study of its proprietary photosensitiser Amphinex® used in combination with the cytotoxic agent bleomycin in cancer patients. Complete clinical regression of all evaluable treated tumours is observed within a few weeks of treatment also on patients at the third dose level, although one patient died of the underlying disease before complete clinical regression could be achieved. No drug-related serious adverse events have been reported.
“The results of treatment in the patients seen so far continue to be very impressive. While this study is primarily aimed at investigating the safety of Amphinex®, the tolerability of normal tissues is an interesting observation that would prove highly beneficial in clinical practice.”
To date eleven patients have been given a single photochemical internalisation (PCI) treatment with Amphinex®. Patients with osteosarcoma and squamous cell carcinoma of the Head & Neck and adenocarinoma of the breast have been included and the effectiveness of the PCI treatment seems to be similar across all cancers treated so far. The PCI-technology could therefore potentially be used for local treatment of several different cancers. Three serious adverse events have been recorded; however not deemed drug-related by the investigator.
The investigators at University College Hospital (UCH) in London have observed an apparent high specificity for cancer cells of the PCI treatment. Tumours of very different depths have been treated and it seems that mainly the cancer cells are killed by the treatment, leaving the healthy tissue underneath the tumour largely unaffected. In addition, one patient with a tumour under the skin has been effectively treated with superficial illumination without ulceration of the skin.