I also came across this article in a German source
https://www.gelbe-liste.de/nachrichten/tookad-neueinfuehrung-prostatakarzinom
Translates to:
"
New launch Tookad
On April 1, 2018 Tookad was introduced for the treatment of adenocarcinoma of the prostate. The drug is a photosensitizer that exerts its effect upon excitation by laser light.
The preparation Tookad of the manufacturer Steba Biotech contains the active ingredient Padeliporfin. After the EU Commission granted marketing authorization in November 2017, Tookad has been on the market since April 2018. The medicine is subject to additional monitoring and, in addition to the product information and package leaflet, a guide for doctors and patients is part of the authorization.
Indication for the use of Tookad
Tookad is indicated for monotherapy in adult patients with previously untreated, unilateral, low-risk adenocarcinoma of the prostate with a life expectancy of ≥ 10 years. Further criteria for the indication are:
clinical stage T1c or T2a
Gleason score ≤ 6, determined by high-resolution biopsy strategies
Prostate Specific Antigen (PSA) ≤ 10 ng / ml
3 positive histological core samples with a maximum cancer core length of 5 mm in any histological core sample or 1 to 2 positive histological core samples with ≥50% cancer involvement in any histological core sample or a PSA density of ≥ 0.15 ng / ml / cm3.
What is Tookad and how is it used?
The active ingredient in Tookad, Padeliporfin, is a water-soluble photosensitizer derived from bacterial chlorophyll.
Tookad is given as a solution for injection. The activation of the drug takes place by means of vascular photodynamic therapy (vascular-targeted photodynamic therapy (VTP)). In the case of VTP, optical fibers are deliberately introduced into the desired areas of the prostate and activated by laser light. This leads to an activation of Padeliporfin, which triggers the production of oxygen radicals. These oxygen radicals lead to destruction of the blood vessels that supply the tumor and ultimately to local necrosis.
Sunscreen in the postoperative period
Due to the photosensitizing effect of Tookad, the patient must be medically monitored and protected from light for at least 6 hours after surgery in a light-attenuated atmosphere. The patient should avoid direct exposure to sunlight during the 48 hours following injection of Tookad.
side effects
The most common side effects, which may affect up to one in four patients, are urinary distress, erectile dysfunction, hematuria, urinary tract infections, and genital pain and bleeding.
Other side effects may occur as part of the general anesthesia necessary to perform VTP. In addition, there may be an increase in liver enzymes.
Contraindications to the use of Tookad
The medicinal product must not be used in patients with cholestasis and in patients with exacerbations of inflammatory bowel disease, e.g. Ulcerative colitis and Crohn's disease. Tookad can not be used in patients who are not considered anesthetized.
study location
The efficacy of Tookad has been investigated in a randomized, multicentre Phase III study.
methodology
413 patients with low-risk prostate cancer (Gleason sample 3, <3 biopsy specimens with tumor detection, length of findings <5 mm in the biopsy cylinder, PSA <10 ng / ml) who had received no prior therapy, were 1: 1 in the therapy arm or randomized to a group with active observation. Treatment failure (histological progression, Gleason> 6) was defined as the primary endpoint within the 24-month follow-up.
Results
In the VTP arm, 28% of patients showed tumor progression, while in the observation arm, 58% of patients progressed. 49% of patients in the VTP arm had a negative biopsy result compared to 14% in the active observation group (adjusted risk stratification: 3 67, 95% CI 2. 53- 5.33, p <0.001).
Probability of a negative biopsy improved
Almost half of Tookad-treated patients showed no signs of prostate cancer at 2 years in the Phase III study. The drug further doubled the average time of progression from low-risk carcinoma to high-risk carcinoma.
Long-term data on the efficacy and safety of Tookad beyond a period of 24 months are currently not available. Also, no conclusions can be made about the efficacy and safety of possibly necessary follow-up treatments such as a radical prostatectomy after Tookad therapy.
sources
Author: Dr. Melanie Klingler
As of: 06.04.2018
"
Tookad was mentioned in the 2017 AGM presentation, where Photosoft was found to generate greater immune responses "providing potential advantages over Tookad".
With Tookad getting EMA approval to begin commercialisation across Europe and seeking a fast tracked FDA approval in USA this could definitely bring PDT into some spotlights.
http://www.globes.co.il/en/article-eu-cttee-approves-israel-cancer-drug-1001206170
(20min delay)