Initiated pre-clinical trials for the use of PCI in the treatment of
Bladder Cancer
(Thomson Reuters ONE) - PCI Biotech has initiated pre-clinical trials for the use ofPhotochemical Internalisation (PCI) in the treatment of Bladdercancer. The pre-clinical trials will be concluded during the firsthalf of 2010, and a phase I/II study (first in man) is expected tostart during 2010.Bladder cancer is a very interesting disease area for the use of thePCI technology. Bladder cancer is the 5th most expensive cancerindication, with the highest average per-patient lift-time cost,mainly due to a high recurrence rate. The currently usedpharmaceutical treatments have limited effect on recurrence andprogression, and there is a large unmet medical need. The bladder iseasily accessible for the three components of the PCI technology; theproprietary photosensitizer Amphinex®, light and a cytotoxic agent.When activated by light, Amphinex® promotes effective delivery oflarge therapeutic molecules through triggered endosomal release andcan thereby enhance the efficacy of drugs. Screening studies in cellcultures indicate that several of the chemotherapeutic drugscurrently used in the treatment of bladder cancer may be enhanced byPCI. Several different chemotherapeutic drugs will be tested in thepre-clinical trials, of which most are already approved for bladdercancer,.The trials will be performed at The Norwegian University of Scienceand Technology (NTNU) in Trondheim, Norway and at Radboud UniversityNijmegen, Holland. The research at Radboud University is performed atone of the leading urology clinics in Europe under the supervision ofProfessor Fred Witjes, and PCI Biotech is very pleased that they haveshown interest in the PCI technology. The pre-clinical trials areexpected to be concluded during the first half of 2010 and PCIBiotech aims to start a phase I/II study during 2010.The company is currently performing a Phase I/II trial at UniversityCollege Hospital (UCH) in London. Amphinex® is in this study combinedwith the cytotoxic agent bleomycin. The study is primarily enrollingpatients with Head & Neck cancer, a disease with local control issuesthat the PCI technology could potentially contribute to solve. Theprimary objective of this study is to assess the maximum tolerateddose of Amphinex®, in PCI treatment with bleomycin. Secondaryobjectives include determination of the antitumour activity ofAmphinex® when used in combination with bleomycin, as well as itspharmacokinetics. The first dose group in the Phase I/II study hasbeen completed, and no serious adverse events have been recorded sofar. Tumour response was seen even at the first low dose. The firstpatients at the next dose level have been treated with Amphinex® andthe results from this dose level and additional results from patientsin the first dose level is expected within the end of the yearAbout PCI BiotechPCI Biotech is a Norwegian biopharmaceutical company developing anovel light directed drug delivery system based on its patentedphotochemical internalisation (PCI) technology. Originating fromworld leading research at the Norwegian Radium Hospital, the PCImethod involves first injecting target cells with a photosensitiser.Therapeutic molecules are then delivered to the cells and when theseare illuminated the cells' endosomes are ruptured to allow successfuluptake.PCI can enhance the delivery of all molecules taken into the cell byendocytosis. This includes most types of macromolecules, drugscarried by antibodies or nanoparticles, as well as some smallmolecule drugs. In addition, PCI enables the use of more toxiccompounds by restricting their effects to the target site.PCI Biotech follows a dual strategy of using its technology toimprove the effect both of existing drugs and for emerging treatmentssuch as gene therapy. PCI Biotech's first clinical study couples theproven photosensitiser Amphinex® with the cytotoxic agent bleomycin.Other studies are planned for the delivery of other cancer drugs inrelevant indications.For more information visit: www.pcibiotech.comContact information:PCI Biotech Holding ASA, Hoffsveien 48, N-0377 Oslo v/Per Walday, CEO, pw(at)pcibiotech.no, Mobile: +47 917 93 429Bernt-Olav Røttingsnes, CFO, bor(at)pcibiotech.no, Mobile: +47 913 47021This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 03.12.2009 - 07:49 Uhr
Sprache: Deutsch
News-ID 9189
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 463 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Initiated pre-clinical trials for the use of PCI in the treatment of
Bladder Cancer"
steht unter der journalistisch-redaktionellen Verantwortung von
PCI Biotech Holding (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
