New data presented on Blue Light Cystoscopy with Cysview®/Hexvix® at the Société Internationale d'Urologie (SIU) 2016 Annual meeting

Oslo, Norway, October 25, 2016 Photocure ASA announced that new data on Blue Light Cystoscopy with Cysview®/Hexvix® were presented at the Société Internationale d'Urologie (SIU) Annual meeting, October 20th to 23rd, Buenos Aires, Argentina: an ePoster from a US registry study and an ePoster video on Blue Light Flexible Cystoscopy.

Data from a prospective multicenter registry from three different centers in the United States (included 220 Blue Light Cystoscopy with Cysview® (BLCC) procedures on 175 patients with 548 lesions), showed that BLCC with Cysview® resulted in an upstaging or upgrading of tumor in 18% of the patients. The addition of BLCC to standard WLC (White Light Cystoscopy) increased the detection rate by 12% in any papillary lesions and 46% for CIS (Carcinoma in Situ).  Furthermore, 60 patients, (34%) received BCG therapy at least six weeks prior to BLCC with a positive predictive value (PPV) of 67% for malignancy (FP=25%). Please see the ePoster here.

“Prior treatment with BCG therapy appears to have no effect on BLCC accuracy.  Many patients receive BCG treatment and it is important to note that the benefits of BLCC can be seen in this patient population as well“, says Siamak Daneshmand, MD, Associate Professor of Urology (Clinical Scholar) Director of Urologic Oncology, at the University of Southern California Institute of Urology and study investigator.  

Additionally a video abstract demonstrated the excellent image quality of Blue Light Flexible Cystoscopy with Hexvix®, using the KARL STORZ Video cystoscopes was presented by Dr. Reza Zare, MD Head of Urology department, Baerum Hospital, Vestre Viken, Norway. Please see the ePoster video here.

“It is very satisfying to see the data from the prospective multicenter registry study and a video abstract on BLC with Cysview®/Hexvix® being presented at the prestigious SIU annual meeting.  The registry study demonstrates how BLCC is changing clinical outcomes and its utility for different patient types including those that have received BCG treatment.  In addition, the video abstract presented very clearly shows how well the new technology of BLCC with flexible cystoscopy performs.” says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA. 

About Bladder Cancer 

Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease1. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 Billion Euro in 20122. 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 is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer 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 treat.

About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydrochloride) is an optical imaging agent used in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence. 

Hexvix® is the tradename in Europe, Cysview® in U.S. and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®.  Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region.  Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

For more information, please contact:

Company contacts:

Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no

Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no


References

1. Globocan. Incidence/mortality by population.  Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx (accessed March 2015)

2. Leal et al, Eur Urol 2016; 69: 438-447

Data from a prospective multicenter registry from three different centers in the United States (included 220 Blue Light Cystoscopy with Cysview® (BLCC) procedures on 175 patients with 548 lesions), showed that BLCC with Cysview® resulted in an upstaging or upgrading of tumor in 18% of the patients. The addition of BLCC to standard WLC (White Light Cystoscopy) increased the detection rate by 12% in any papillary lesions and 46% for CIS (Carcinoma in Situ).  Furthermore, 60 patients, (34%) received BCG therapy at least six weeks prior to BLCC with a positive predictive value (PPV) of 67% for malignancy (FP=25%).  Please see the ePoster here.

"Prior treatment with BCG therapy appears to have no effect on BLCC accuracy.  Many patients receive BCG treatment and it is important to note that the benefits of BLCC can be seen in this patient population as well", says Siamak Daneshmand, MD, Associate Professor of Urology (Clinical Scholar) Director of Urologic Oncology, at the University of Southern California Institute of Urology and study investigator.  

Additionally a video abstract demonstrated the excellent image quality of Blue Light Flexible Cystoscopy with Hexvix®, using the KARL STORZ Video cystoscopes was presented by Dr. Reza Zare, MD Head of Urology department, Baerum Hospital, Vestre Viken, Norway.  Please see the ePoster video here.

"It is very satisfying to see the data from the prospective multicenter registry study and a video abstract on BLC with Cysview®/Hexvix® being presented at the prestigious SIU annual meeting.  The registry study demonstrates how BLCC is changing clinical outcomes and its utility for different patient types including those that have received BCG treatment.  In addition, the video abstract presented very clearly shows how well the new technology of BLCC with flexible cystoscopy performs." says Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.

About Bladder Cancer
Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease1. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 Billion Euro in 20122. 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 is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer 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 treat.

About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydrochloride) is an optical imaging agent used in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.

Hexvix® is the tradename in Europe, Cysview® in U.S. and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®.  Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region.  Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.