Photocure ASA announced that its partner Asieris Pharmaceuticals has unveiled the results of its Hexvix[®] (APL-1706) Phase III clinical trial in China. A presentation scheduled for at the 43[rd] Congress of the Société Internationale d'Urologie (SIU), confirms that, in a Chinese population, Hexvix blue light cystoscopy (BLC[®]) outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability. The highly statistically significant results corroborate the findings of Photocure's own randomized controlled trials (RCTs) that demonstrate the clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection and a favorable tolerability profile with no serious adverse events.

Moreover, Asieris' Phase III Hexvix trial is the first RCT conducted with high definition 4K blue light capital equipment. The trial results have been selected as a "late-breaking abstract" at the 43[rd] Congress of the Société Internationale d'Urologie (SIU) in Istanbul, Turkey, October 11-14. The clinical study data will be presented on October 12, in the form of an Oral ePoster at 1:45pm local time.

The study is a prospective, self-controlled, multicenter Phase ? study intended to evaluate the safety and detection benefits of blue light cystoscopy (BLC[®]) with Hexvix compared to white light cystoscopy (WLC) in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. The study included a total of 158 patients, of which 114 underwent BLC.

Of the 97 patients diagnosed with NMIBC, a total of 42 patients (43.3%) had one or more additional lesions detected with Hexvix BLC compared to WLC (p<0.0001). Among the 114 patients, 11.4% (13/114) had CIS lesions, and among these, 11 patients (84.6%, 11/13) had additional CIS lesions detected under Hexvix BLC that were not found under WLC. The detection rates for PUNLMP, CIS, Ta, T1, and T2-T4 tumor lesions in the BLC group were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while in the WLC group, they were NA, 42.1%, 76.1%, 91.2%, and 100%, respectively.