PCI Biotech reports successful completion of second dose group in a Phase I/II Amphinex® trial. Stro
(Thomson Reuters ONE) - PCI Biotech reports successful completion of second dose group ina Phase I/IIAmphinex® trial. Strong anti-tumour response observed in all patientsOslo, 19 January 2010 - PCI Biotech reported today that it has completed thetreatment of the second dose group in the phase I/II study of its proprietaryphotosensitiser Amphinex® used in combination with the cytotoxic agent bleomycinin cancer patients. To date seven patients have been given a singlephotochemical internalisation (PCI) treatment of Amphinex® with all the treatedtumours in all patients disappearing within a few weeks of treatment.Furthermore, no drug-related serious adverse events have been recorded."We are veryexcited by the positive results that have been reported fromUniversity College Hospital (UCH) in London. The strong antitumour responseseen in all patients treated with Amphinex® is far better than expected at thefirst dose levels and indicates that the positive pre-clinical results obtainedwith our PCI technology are transferrable to treatment in humans", says PCIBiotech CEO Per Walday.When activated by light, Amphinex® promotes effective local delivery of avariety of therapeutic molecules, e.g. bleomycin, through triggered endosomalrelease. The primary objective of the UCH study is to assess the maximumtolerated dose of Amphinex®, in PCI treatment with bleomycin. Secondaryobjectives include determination of the antitumor activity of the treatment, aswell as the pharmacokinetics of Amphinex®. The study has also been designed toinclude patients with as wide as possible a range of cancers and has alreadyincluded sarcoma, breast, and head and neck cancer patients. The effectivenessof the PCI treatment seems to be similar across all cancers treated so far, withall the treated tumours disappearing within a few weeks of treatment. ThePCI-technology could therefore potentially be used for local treatment ofseveral different cancers.The patients at the third dose level of Amphinex® will now be treated as soon aspossible, with preliminary results from the complete trial expected within thefirst half of 2010.About PCI BiotechPCI Biotech is a Norwegian biopharmaceutical company developing a novel lightdirected drug delivery system based on its patented photochemicalinternalisation (PCI) technology. Originating from world leading research at theNorwegian Radium Hospital, the PCI method involves first injecting target cellswith a photosensitiser.Therapeutic molecules are then delivered to the cells and when these areilluminated the cells' endosomes are ruptured to allow successful uptake.PCI can enhance the delivery of all molecules taken into the cell byendocytosis. This includes most types of macromolecules, drugs carried byantibodies or nanoparticles, as well as some small molecule drugs. In addition,PCI enables the use of more toxic compounds by restricting their effects to thetarget site.PCI Biotech follows a dual strategy of using its technology to improve theeffect both of existing drugs and for emerging treatments such as gene therapy.PCI Biotech's first clinical study couples the proven photosensitiser Amphinex®with the cytotoxic agent bleomycin. Other studies are planned for the deliveryof other cancer drugs in relevant indications.For more information visit: www.pcibiotech.comContact information:PCI Biotech Holding ASA, Strandveien 55, N-1366 LysakerPer Walday, CEO, pw(at)pcibiotech.no, Mobile: +47 917 93 429Bernt-Olav R?ngsnes, CFO, bor(at)pcibiotech.no, Mobile: +47 913 47 021International media inquiries:Richard Hayhurst, Schwartz Commuications UK LimitedRHayhurst(at)schwartz-pr.co.uk
Datum: 19.01.2010 - 08:33 Uhr
Sprache: Deutsch
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