Photocure: New data from Hexvix® trials presented at the BLADDR 2019 congress

Oslo, Norway, October 28th, 2019: today Photocure ASA announced highlights from the BLADDR 2019 congress, October 25-26 in Paris, France. The BLADDR congress is solely focused on bladder cancer and attracts bladder cancer experts from all over the world.

Data from two Hexvix studies were presented at the congress:

Antitumor effect and induced systemic immune effects of HAL and blue light in an orthotopic model of rat bladder cancer, presented by Kari Myren, MD, Head of Global Medical Affairs and Clinical Development, Photocure, Oslo, Norway. These are the first published data from a pre-clinical study investigating potential treatment effects of Blue Light Cystoscopy (BLC™) with Hexvix. The results of the study indicate for the first time that a treatment effect could be related to immunogenic cell death responses and anti-tumor immune cell activation.

Here is a link to the abstract: https://bit.ly/2kKnE7Y

The second abstract was based on results from the Nordic registry study with Hexvix and flexible cystoscopes in the office setting: Malignant urinary cytology of unknown origin – blue light flexible cystoscopy with Hexaminolevulinate (HAL) at the outpatient clinic may be a valuable diagnostic and therapeutic tool, presented by Marie Andersson, Department of Urology, Helsingborg hospital, Sweden.

The author concluded that flexible BLC with flexible cystoscopes in the outpatient clinic may in a simple way solve many unclear cases with malign or suspicious urinary cytology. The procedure is well tolerated and generally preferred by patients over a procedure in the operating room under general anesthesia.

Here is a link to the abstract: https://bit.ly/2kzsRQf

“It is encouraging to see new data on Hexvix being presented at an international bladder cancer expert congress, clearly showing the immense potential Hexvix has. The flex study demonstrating how using Hexvix in the outpatient clinic/office can solve challenging cases for the benefit of patients and providers, and the first pre-clinical data indicating that Blue Light cystoscopy with Hexvix might have a treatment effect. These early data are very exciting, and we look forward to exploring this further”, says Dan Schneider, President and CEO of Photocure.   


About Bladder Cancer

Bladder cancer ranks as the ninth most common cancer worldwide with 430 000 new cases and more than 165 000 deaths annually. Approx. 75% of all bladder cancer cases occur in men1. It has a high recurrence rate with an average of 61% in year one and 78% over five years2. Bladder cancer has the highest lifetime treatment costs per patient of all cancers3.

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. MIBC is when 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 treat4.

About Hexvix®/Cysview® (hexaminolevulinate HCl)

Hexvix®/Cysview® is a drug that is selectively taken up by tumor cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLC™ with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Cysview® / Hexvix® directly in the US and the Nordic region and has strategic partnerships for the commercialization of Hexvix® / Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on our commercial partners.

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

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References

1. Globocan. Incidence/mortality by population.  Available at: http://globocan.iarc.fr/Default.aspx
2. Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al. EAU Guidelines on non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016 Guidelines Edition:1-40.
3. Sievert KD et al. World J Urol 2009;27:295–300
4. Bladder Cancer. American Cancer Society.  https://www.cancer.org/cancer/bladder-cancer.html