PCI Biotech (PCI) has initiated the phase I/II trial with the first patient treatment with its lead candidate, Amphinex.
PCI’s proprietary photosensitiser Amphinex is in the study combined with the therapeutic agent bleomycin. When activated by light, Amphinex promotes effective delivery of large therapeutic molecules such as bleomycin through triggered endosomal release.
Reportedly, the trial will investigate a broadly representative spectrum of cancers including head and neck cancer and breast cancer, to demonstrate the safety and potential of the new approach.
The primary objective of the study is to assess the maximum tolerated dose of Amphinex, in PCI treatment with bleomycin. Secondary objectives include determination of the antitumor activity of Amphinex when used in combination with bleomycin, as well as its pharmacokinetics.
Per Walday CEO of PCI, said: This first in man trial is an important step forward for the company. We are confident that our approach addresses one major challenge in oncology – how to deliver therapeutics with large enough loads to effectively destroy tumours while at the same time reducing the risk of damaging healthy cells. Bleomycin is ideal for demonstrating this – there is no doubt about its therapeutic potential, but until now delivery problems and associated toxicity have prevented the realisation of its full potential. We expect to have the first preliminary results of the trial early in 2010.