Pinnacle Biologics files for new indication in Germany and France

AMSTERDAM and BANNOCKBURN, Illinois, Dec. 5, 2012 /PRNewswire/ -- Pinnacle Biologics, BV., announced today it has filed a national pharmaceutical variation with the German and French health agencies, the Federal Institute for Drugs and Medical Devices and the National Agency for the Safety of Medicine and Health Products respectively, for Photodynamic therapy (PDT) with PHOTOFRIN® (porfimer sodium) for the therapeutic indication unresectable advanced hilar cholangiocarcinoma (CCA).  Pinnacle is a bio-pharmaceutical technology company developing and manufacturing novel therapies for oncology and rare diseases.

Hilar CCA (Klatskin tumor) proposed in the above indication is a rare cancer subset arising at the convergence of the right and left hepatic duct[1].

"This filing reflects our continued commitment to make PDT therapy available for physicians and patients worldwide and more importantly, to continue to develop therapies that treat rare diseases like cholangiocarcinoma," said Guillermo Herrera, Pinnacle Executive Chairman and CEO.

About Photodynamic therapy (PDT) and PHOTOFRIN

Photodynamic therapy with PHOTOFRIN is a two-stage process requiring administration of both drug and light. The first stage of PDT is the intravenous injection of PHOTOFRIN. The second stage of therapy uses illumination with non-burning laser light 40–50 hours following injection with PHOTOFRIN. When injected, PHOTOFRIN is attracted to certain tissues, especially cancer cells. Tumor destruction results from biochemical reactions, not heat.  Tumor selectivity occurs through a combination of preferential retention of PHOTOFRIN by the tumor and selective delivery of light to the tumor site.

Currently approved indications for PHOTOFRIN in France are for the treatment of recurrences of non-small cell bronchial cancer or esophageal cancer, which have been previously treated loco-regionally. In Germany, approved indications for PHOTOFRIN are for the curative treatment of patients with histologically proven non-small cell endobronchial early carcinomas (Stage T is NO MO or T1 NO MO), which according to the responsible physician could not be curatively treated by surgery or radiotherapy.

Pinnacle recently acquired the laser and fiber technology used in PDT. The acquisition creates a complete portfolio for the company, which now includes all the PHOTOFRIN PDT treatment components.

Important Safety Information

For important safety information about the currently licensed indications please refer to the local PHOTOFRIN Patient Information Leaflet.

About Pinnacle

Pinnacle Biologics Inc. is a privately held bio-pharmaceutical company specializing in revitalizing healthcare therapies to expand therapeutic potential and maximize favorable patient outcomes. The company is headquartered in Bannockburn, Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

[1] Bragazzi MC, Cardinale V, Carpino G, Venere R, Semeraro R, Gentile R, Gaudio E, Alvaro D. Cholangiocarcinoma: Epidemiology and risk factors. Transl Gastrointest Cancer 2012;1:21-32. DOI: 10.3978/j.issn.2224-4778.2011.11.04

SOURCE Pinnacle Biologics, Inc.