Sage represents Luzitin (www.luzitin.pt) to develop a strategic alliance for its Redaporfin PDT combination therapy for solid tumours.
For decades Photodynamic Therapy (PDT) to treat cancer has held great promise due to its ability to selectively destroy tumours accessible to light along with the absence of harmful long term side effects often encountered with chemotherapy or radiotherapy.
However, technological limitations of current marketed products have heretofore prevented PDT from reaching its full potential. Luzitin has developed a new photosensitizer compound, Redaporfin™, which promises to bring PDT to routine daily practice for treatment of solid tumours. Luzitin’s Redaporfin™treatment is a novel product which is applicable to virtually all solid tumours accessible to minimally invasive illumination through an optical fibre.
Redaporfin is a patented, third generation photosensitizer compound which was specifically designed to overcome the pitfalls of the marketed photosensitizers of systemic administration for cancer (i.e. porfimer sodium - Photofrin®, and temoporfin - Foscan®).
Redaporfin™ exhibits a higher efficacy because it is more phototoxic than Photofrin® and Foscan® (higher capacity to absorb light and generate ROS) and the observed depth of tissue necrosis is much higher (up to 18 mm versus 2-6 mm).
The entire PDT treatment with Redaporfin™ is concluded in 30 minutes while the entire PDT treatment with Foscan and Photofrin lasts for more than 2 days which is very inconvenient for patients and doctors and has a high cost due to long hospital stays.
Pharmacodynamic studies of Redaporfin™ have demonstrated its potent antitumor effect and immunologic activity. Using human colon carcinoma tumor cells in a mouse model, Redaporfin, across three different doses, achieved a 38% “cure rate” (no visible tumour) after 60 days following a 15 minute treatment. At the highest dose, an 87% “cure rate” was achieved. Additionally, 67% of these Redaporfin™ treated mice rejected a post treatment challenge indicating a potent immunologic memory effect. Moreover, in a separate mouse study using the same colon carcinoma tumor cells, there was a significant reduction compared to the control group in the amount of lung metastases when the primary tumor was treated with Redaporfin PDT. In fact, two of the seven Redaporfin treated mice had no lung metastasis.
These immunologic effects are valuable in their own right and also establish a basis for considering the combination of Redaporfin PDT with immune checkpoint inhibitors.
Based on the Redaporfin™’s promising results in the non-clinical studies and in a Phase I/IIA PoC study for advanced head and neck cancer, Luzitin plans to meet with EMA to propose a pivotal study of Redaporfin™ PDT in biliary tract cancer for which Luzitin has already received orphan drug designation from EMA. Luzitin plans to seek the same designation in the next few months from the FDA.