Date: 2016-07-28
Type of information: Publication of results in a medical journal
phase: 1
Announcement: publication of results in The Lancet Oncology
Company: PCI Biotech (Norway)
Product: fimaporfin - disulfonated tetraphenyl chlorin (TPCS2a) (Amphinex™)
Action mechanism:
Disease: advanced solid tumours
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On July 28, 2016, PCI Biotech reported that the first-in-man Phase I study with PCI Biotech’s proprietary drug fimaporfin (Amphinex™) performed at University College Hospital in London in patients with various advanced solid tumours has been published in Lancet Oncology. The article is entitled “Disulfonated tetraphenyl chlorin (TPCS2a)-induced photochemical internalization of bleomycin in patients with solid malignancies: A first-in-man phase I dose escalation clinical trial”. In this clinical phase I study PCI Biotech’s proprietary photosensitiser fimaporfin was given at escalating doses in combination with the cytotoxic drug bleomycin to 22 patients with advanced and recurrent cancer. The treatment was found safe and tolerable, and significant anti-tumour effect were seen at all dose levels in this patient population with aggressive cutaneous and sub- cutaneous tumours. PCI Biotech has a clinical Phase I/II program in bile duct cancer. The indication is well suited for PCI treatment, with easy light access through routine endoscopic methods and an active generic drug (gemcitabine) significantly enhanced by PCI. The company is also developing PCI as a vaccination technology. When applied in the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines.