07:00 , Jun 29, 2015 |  BC Week In Review  |  Clinical News

Amphinex: Phase II discontinued

PCI Biotech discontinued the open-label, European Phase II ENHANCE trial of 0.25 mg/kg IV Amphinex followed by laser therapy. The company cited increased competition by emerging immunotherapies for the indication and said optimization of the...
08:00 , Feb 10, 2014 |  BC Week In Review  |  Clinical News

Amphinex: Phase I/II started

PCI began an open-label, dose-escalation, European Phase I/II trial to compare a single treatment of Amphinex plus IV gemcitabine followed by gemcitabine plus IV cisplatin vs. gemcitabine plus cisplatin in about 61 patients with locally...
08:00 , Mar 4, 2013 |  BC Week In Review  |  Clinical News

Amphinex: Phase II amended

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...
08:00 , Dec 17, 2012 |  BC Week In Review  |  Clinical News

Amphinex: Phase II amended

PCI Biotech will modify the treatment regimen for intra-tumor illumination in the open-label, European Phase II ENHANCE trial evaluating Amphinex followed by laser therapy while continuing enrollment of patients who only require surface illumination. According...
07:00 , Jun 4, 2012 |  BC Week In Review  |  Clinical News

Amphinex: Extension study completed enrollment

PCI Biotech completed enrollment of 3 patients in an extension study of a U.K. Phase I/II trial evaluating IV Amphinex plus bleomycin given at doses below the maximum tolerated dose. The extension study was slated...
07:00 , Apr 9, 2012 |  BC Week In Review  |  Clinical News

Amphinex: Phase II started

PCI Biotech began an open-label, European Phase II trial to evaluate a single treatment of 0.25 mg/kg IV Amphinex in combination with bleomycin followed by laser therapy in about 80 head and neck cancer patients....
08:00 , Mar 5, 2012 |  BC Week In Review  |  Clinical News

Amphinex: Extension study started

PCI Biotech began an extension study of a U.K. Phase I/II trial to evaluate IV Amphinex plus bleomycin given at doses below the maximum tolerated dose (MTD) in up to 9 patients. Last year, PCI...
07:00 , Oct 31, 2011 |  BC Week In Review  |  Clinical News

Amphinex regulatory update

PCI said EMA's CHMP recommended the biotech develop Amphinex as a single product for use with bleomycin to treat head and neck cancer instead of a combination package of Amphinex and bleomycin. The biotech said...
07:00 , Jul 4, 2011 |  BC Week In Review  |  Clinical News

Amphinex: Additional Phase I/II data

Additional data from an open-label, dose-escalation, U.K. Phase I/II trial showed that IV Amphinex plus bleomycin chemotherapy led to complete clinical regression of target tumors in 14 of 16 evaluable patients at week 4 and...
07:00 , Apr 18, 2011 |  BC Week In Review  |  Clinical News

Amphinex regulatory update

The Norwegian Medicines Agency approved PCI Biotech's Amphinex for compassionate use in a single patient to treat sarcoma. The photosensitizer for photodynamic therapy (PDT) is in Phase I/II testing to treat cancer. PCI Biotech Holding...