Blue Light Cystoscopy (BLCTM) with Hexvix® was featured through abstract presentations, a symposium hosted by Ipsen, our strategic partner in Europe except the Nordic, and exhibited both at the Ipsen and Photocure booths.
Ditte Drejer, Aarhus University Hospital, Denmark, presented base line results from the Da-Bla-Ca 11 trial: Photodynamic diagnosis in flexible cystoscopy – initial findings in a randomized controlled trial (abstract 1140). 605 patients were enrolled from three urological departments in Denmark. The initial results indicate that Blue Light flexible cystoscopy with Hexvix can reduce the need of TURBT when biopsy and fulguration of small tumors is possible in the outpatient/office clinic. Further follow-up data on recurrences is ongoing and will be needed to estimate the clinical impact on reduction of recurrence risk and repeated procedures.
Dr. Siamak Daneshmand, University of Southern California Institute of Urology presented data from a registry study with 533 patients, 1632 identified lesions from 641 BLC™ procedures across 9 different centers: Blue light cystoscopy for diagnosis of urothelial bladder cancer: Results from a multicenter registry (abstract 1139). BLC with Cysview increases detection rates of all tumor types compared to standard white light, especially CIS lesions (43%), and changed the management in about 14% of patients. Furthermore, recent BCG therapy did not appear to impact the BLC accuracy.
Professor Morgan Roupret, Academic Department of Urology of Pitié-Salpétrière, Paris, France presented “Predicting the future of PDD - blue skies or dark clouds” at the Ipsen hosted symposium Saturday March 17. This presentation challenged the continuing role of photodynamic-diagnosis amidst the emerging trends in NMIBC management. It concluded that combined with biomarker testing and targeted biopsies, PDD will remain key to optimal treatment and patient follow-up.
Kjetil Hestdal, President and CEO comments: “It was a great pleasure to be present at the EAU congress in one of the European countries where we market Hexvix ourselves, and see the engagement and activities at our booth in addition to the new data on BLC with Hexvix/Cysview being presented. With the recent FDA approval of Cysview with flexible scopes it is especially encouraging with the initial data from the Danish investigator initiated trial indicating how BLC with flexible scopes might change the patient pathway and reduce the burden on health care costs and make life better for the patients”.
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCTM with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, less 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 Hexvix®/Cysview® 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://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.
For more information, company contacts:
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO). More information about Photocure is available at www.photocure.com, www.hexvix.com, www.cysview.com
About Bladder Cancer
There are 167 000 new cases of bladder cancer in Europe and more than 59 000 deaths from the disease 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 years, making the lifetime costs of managing bladder cancer one of the highest amongst all. Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence3,4. 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 2012.2
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 treat.5
1. Globocan. Incidence/mortality by population.
Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2. Leal et al, Eur Urol 2016; 69: 438-447
3. 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.
4. Sievert KD et al. World J Urol 2009;27:295–300
5. Bladder Cancer. American Cancer Society https://www.cancer.org/cancer/bladder-cancer.html
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