BioCentury
ARTICLE | Clinical News

Amphinex: Phase II amended

March 4, 2013 8:00 AM UTC

PCI Biotech said it will amend the open-label, European Phase II ENHANCE trial of 0.25 mg/kg IV Amphinex followed by laser therapy to include patients with metastatic head and neck cancer with a need for local disease treatment to speed up enrollment. The trial, which has treated 8 patients, is evaluating a single treatment of Amphinex in combination with bleomycin followed by either intra-tumor or surface illumination laser therapy in about 80 head and neck cancer patients. The company said the change is due to "slower than initially expected" patient inclusion. Additionally, PCI Biotech will optimize the intra-tumor illumination procedure in a parallel part of the trial. The total number of patients in the parallel study will depend on the number of dose escalations needed to find a safe and efficient light dose. Final confirmation of the light dose for the ENHANCE trial will be tested in 12-15 patients, who will be included in ENHANCE. PCI Biotech expects to start enrollment in the parallel part next quarter, with completion of the proof of concept (POC) for intra-tumor treatment slated next half or early next year. ...