First patient included in the phase II study of Amphinex® in head and neck cancer patients

PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that the first patient has been included in the phase II study of Amphinex in combination with the cytotoxic agent bleomycin in head and neck cancer patients, called the ENHANCE study. The first patient was included at the National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Germany. NCT is a joint project of the German Cancer Research Center (DKFZ), Heidelberg University Hospital, Thoraxklinik Heidelberg and Deutsche Krebshilfe (German Cancer Aid).

Coordinating investigator of the study, Dr Jürgen Krauss at NCT, said: "This is an important stage in the search to find improved treatments for patients with localised recurrent head and neck cancer. The phase I study has shown that Amphinex in combination with bleomycin has the ability to produce significant local tumour responses in these patients, who are lacking good alternative treatment options. The ENHANCE study is well designed to demonstrate the potential clinical benefit of Amphinex treatment in this patient group and I look forward to working with my fellow investigators to complete this study according to schedule."

Per Walday, CEO of PCI Biotech, said: "The start of the ENHANCE study is a major milestone for PCI Biotech. We have invested a great deal of time with international key opinion leaders, investigators and regulatory authorities to design a phase II study that will allow us to demonstrate the clinical benefit that Amphinex combined with bleomycin may provide to patients with recurrent head and neck cancer."

The ENHANCE study is a single arm, multi-centre, phase II study to evaluate the safety and efficacy of Amphinex in combination with bleomycin with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and without distant metastases. The study will include approximately to 80 patients, and patient inclusion will be in 2012 and 2013

The study will initially run at University College Hospital (UCH) in London, UK, National Center for Tumor Diseases (NCT) in Heidelberg, Germany, Ludwig Maximilian University Munich, Germany, The Netherlands Cancer Institute in Amsterdam, Netherlands and Centre Alexis Vautrin (CAV)-Nancy Université, France, all highly respected cancer institutes. Further hospitals in countries where the study protocol is already approved are being approached and will be considered for site selection in order to ensure rapid patient inclusion.

About PCI Biotech
PCI Biotech is a Norwegian biopharmaceutical company developing a novel light directed drug delivery system based on its patented photochemical internalisation (PCI) technology. Originating from world leading research at the Norwegian Radium Hospital, the PCI method involves first injecting Amphinex® and thereafter the therapeutic drug to be specifically delivered to the diseased cells. When these are illuminated the cells' endosomes are ruptured to allow successful intracellular delivery of the drug.

PCI can enhance the delivery of all molecules taken into the cell by endocytosis. This includes most types of macromolecules, drugs carried by antibodies or nanoparticles, as well as some small molecule drugs.

PCI Biotech follows a dual strategy of using its technology to improve the effect both of existing drugs and for emerging treatments such as gene therapy. PCI Biotech's first clinical study combines the proven photosensitiser Amphinex® with the cytotoxic agent bleomycin. Other studies are planned for the delivery of other cancer drugs in relevant indications.

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