Per Walday, CEO of PCI Biotech, said: “We are very excited by the positive results that have been reported from University College Hospital (UCH) in London. The strong antitumour response seen in all patients treated with Amphinex® is far better than expected at the first dose levels and indicates that the positive pre-clinical results obtained with our PCI technology are transferrable to treatment in humans.”
The company claims that when activated by light, Amphinex promotes effective local delivery of a variety of therapeutic molecules, for example, bleomycin, through triggered endosomal release.
The primary objective of the UCH study was to assess the maximum tolerated dose of Amphinex in PCI treatment, using bleomycin as the test molecule. Secondary objectives include determination of the antitumor activity of the treatment, as well as the pharmacokinetics of Amphinex.
The study was designed to include patients with as wide as possible range of cancers and has already included sarcoma, breast, and head and neck cancer patients. The effectiveness of the PCI treatment seems to be similar across all cancers treated so far, with all the treated tumours disappearing within a few weeks of treatment. The PCI-technology could therefore potentially be used for local treatment of several different cancers.
The patients at the third dose level of Amphinex is expected to be treated as soon as possible, with preliminary results from the complete trial expected within the first half of 2010.