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PCI Biotech completes treatment of third dose group in Amphinex study.

M2 EUROPHARMA-(C)1999-2010 M2 COMMUNICATIONS

17 March 2010 - Norwegian biopharmaceutical company PCI Biotech (OSL: PCIB) reported yesterday 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.

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 and 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.

Principal Investigator Colin Hopper at UCH in London said that the treatment results 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, Hopper added.

The primary objective of the UCH study is to assess the maximum tolerated dose of Amphinex, in PCI treatment with bleomycin. Secondary objectives include determination of the antitumor activity of the treatment, as well as the pharmacokinetics of Amphinex. Preliminary analysis of the pharmacokinetic data indicates that Amphinex has a half-life in blood of about 18 days.

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Publication:M2 Pharma
Date:Mar 17, 2010
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