Photocure ASA announced that its partner Asieris Pharmaceuticals has communicated its plan to unveil the first results of its Hexvix® (APL-1706) Phase III clinical trial in China. The pivotal clinical trial results have been selected as a "late-breaking abstract" for the 43rd Congress of the Societe Internationale d'Urologie (SIU) in Istanbul, Turkey, this month. The clinical study results will be presented for the first time in the form of an Oral ePoster on October 12, 2023, at 1:45pm local time.

The study is a prospective, self-controlled, multicenter Phase III study intended to confirm results from prior clinical trials regarding the safety and detection benefits of blue light cystoscopy (BLC) 4K high definition with Hexvix compared to white light cystoscopy (WLC) in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. The primary endpoint in the trial is the rate of additional detection of one or more lesions including tumors with stages of carcinoma in situ (CIS), Ta, and T1 by APL-1706 BLC compared to WLC. As previously communicated, the study reached its primary research endpoint in August 2023 and the full results are expected to be submitted to Chinese regulators in support of a new drug application (NDA) in the coming months.

Asieris Pharmaceuticals is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. In January 2021, Asieris entered into a license agreement with Photocure ASA to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan. Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence.

There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike. Bladder cancer is classified into two types, non-muscle invasive bladder Cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder.

These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (Cis) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.