Oslo, 10 December 2012 - PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that it will modify the study protocol for the ENHANCE study in head and neck cancer patients. Two different light application procedures are used in this study; surface and intra tumour illumination. The ENHANCE study will continue to include patients where the tumour can be treated with surface illumination, while the treatment procedure for intra tumour illumination will be optimized.
Preliminary findings from some of the patients included in the ENCHANCE study indicates that treatment with intra tumour illumination causes stronger local treatment effects than expected and desired, and stronger treatment effects than what was observed with surface illumination in the Phase I/II-study at University College Hospital in London, UK. The Independent Data Monitoring Board has therefore recommended the company to optimise the treatment regime for intra tumour illumination before further patients are treated with this procedure.
The company will now start to assess how to optimise the intra tumour procedure, and evaluate possible changes to the protocol to speed up the development of Amphinex used in combination with bleomycin.
The development of Amphinex used in combination with gemcitabine in treatment of bile duct cancer, and the development of PCI used to enhance the effect of vaccines is progressing according to plan. The new information about the effects with intra tumour illumination will be taken into consideration in the dose finding part of the clinical study in patients with bile duct cancer.
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. A clinical study for the use of PCI in treatment of patients with bile duct cancer is being planned. In this indication, Amphinex will be used in combination with the generic cytotoxic agent gemcitabine. The aim is to include the first patient by end of 1H 2103. A preclinical program to investigate the use of PCI to enhance the effect of vaccines is ongoing, with the aim to establish a protocol for a clinical study that can start in 2013.
For more information visit: www.pcibiotech.com
Contact information:
PCI Biotech Holding ASA, Strandveien 55, N-1366 Lysaker
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429
Bernt-Olav Røttingsnes, CFO, bor@pcibiotech.no, Mobile: +47 913 47 021
Preliminary findings from some of the patients included in the ENCHANCE study indicates that treatment with intra tumour illumination causes stronger local treatment effects than expected and desired, and stronger treatment effects than what was observed with surface illumination in the Phase I/II-study at University College Hospital in London, UK. The Independent Data Monitoring Board has therefore recommended the company to optimise the treatment regime for intra tumour illumination before further patients are treated with this procedure.
The company will now start to assess how to optimise the intra tumour procedure, and evaluate possible changes to the protocol to speed up the development of Amphinex used in combination with bleomycin.
The development of Amphinex used in combination with gemcitabine in treatment of bile duct cancer, and the development of PCI used to enhance the effect of vaccines is progressing according to plan. The new information about the effects with intra tumour illumination will be taken into consideration in the dose finding part of the clinical study in patients with bile duct cancer.
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. A clinical study for the use of PCI in treatment of patients with bile duct cancer is being planned. In this indication, Amphinex will be used in combination with the generic cytotoxic agent gemcitabine. The aim is to include the first patient by end of 1H 2103. A preclinical program to investigate the use of PCI to enhance the effect of vaccines is ongoing, with the aim to establish a protocol for a clinical study that can start in 2013.
For more information visit: www.pcibiotech.com
Contact information:
PCI Biotech Holding ASA, Strandveien 55, N-1366 Lysaker
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429
Bernt-Olav Røttingsnes, CFO, bor@pcibiotech.no, Mobile: +47 913 47 021
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.