Luzitin’s Redaporfin treatment is a novel combination therapy which is applicable to virtually all solid tumors accessible to minimally invasive illumination with its optical fibre laser light source.
Redaporfin is a third generation bacteriochlorin molecule which has a greater ability to absorb light and convert it into active molecular species (reactive oxygen species), better depth penetration, and improved efficacy.
Redaporfin has promising Phase I/IIA POC clinical data in advanced head and neck cancer which clearly reinforces the favorable results from non-clinical studies.
PDT with Redaporfin has potential advantages over existing cancer treatments:
- Highly effective
- Good tolerability profile
- Easy to use
- Highly favorable cost-effectiveness
Redaporfin development has been partially funded by Quadro de Referência Estratégica Nacional (QREN), Project No. 5356.
Main target indications
ORPHAN DRUG DESIGNATION FROM EMA FOR BILIARY TRACT CANCER
Redaporfin has received Orphan Drug Designation (ODD) from EMA in Europe for Biliary tract cancer. A pivotal Phase III study is planned. This provides a further opportunity for fast track status. Application for ODD by the FDA is planned for later in 2016. Redaporfin has the potential to become a first in class product for biliary tract cancer/cholangiocarcinoma, with high unmet medical needs.
REDAPORFIN HAS POTENTIAL FOR COMBINATION THERAPY WITH IMMUNE CHECKPOINT INHIBITORS
Initial nonclinical in vivo studies have demonstrated an extraordinary level of immunologic effect including reduced metastasis and immunologic memory. Redaporfin’s demonstrated ability to induce activation of antigen-specific T cells, including neoantigens, could improve the efficacy of an unleashed immune system created by immune checkpoint inhibitors.