Regulatory Filings • May 15, 2020
Regulatory Filings
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OSLO, Norway, 15 May2020 -- Photocure ASA (OSE: PHO) today announced key data was published by the 2020American UrologicalAssociation (AUA) Annual Virtual Meeting. Three abstracts featured Blue Light Cystoscopy (BLC™) with Cysview, and on June 27, 2020 BLC with Cysview will be included in a virtual session of the AUA program: "Surgical Techniques: Tips & Tricks Oncology: Bladder Cancer Blue Light" with Dr. Anne Schuckman.
MP 73-11: Role of blue light cystoscopyin detecting invasive bladder tumor: Data froma multi-institutional registry https://www.auajournals.org/doi/10.1097/JU.0000000000000959.011
MP 24-06:Gender based Variations in the Detection of Bladder Cancer with Blue Light Cystoscopy: Insights froma Multicenter Registryhttps://www.auajournals.org/doi/10.1097/JU.0000000000000857.06
MP 73-02: Malignant urinarycytologyof unknown origin-blue light flexible cystoscopyat the outpatient clinic maybe a valuable diagnostic tool https://www.auajournals.org/doi/10.1097/JU.0000000000000959.02
The Role of blue light cystoscopyin detecting invasive bladder tumor: Data froma multi-institutional registryshowed that in the registry enrolled patients, a considerable proportion of invasive bladder tumors were detected by BLC alone: A total of 55 invasive lesions, of the 494 invasive lesions detected, were detected only by blue light cystoscopy. The benefit of using BLC in earlier detection of invasive bladder tumors could have an effect on the treatment approach and potentially lead to improved survival in the high-risk population. The study included 3514 lesions (1257 unique patients), from 9 sites in the U.S.
"Out of the overall 494 invasive lesions detected, 11% of them were only detected by BLC alone. Also, of 47 patients with BLC-only positive invasive lesions, 60% had concurrent CIS and 49% had an additional T1 lesion. Knowing when these high-risk tumors are present, especially concurrently, is critical to the optimal management of a patient's disease. We need this information in order to make the best treatment decisions, which can have a significant impact on the prognosis and quality of life, for our patients." says Siamak Daneshmand, MD, Director of Urologic Oncology Associate Professor of Urology, USC Institute of Urology.
Gender based Variations in the Detection of Bladder Cancer with Blue Light Cystoscopy: Insights froma Multicenter Registry showed that similar to existing evidence, BLC-alone was significantly more sensitive than WLC-alone in males (91.1% vs 80.0%, p<0.001) and in females (86.7% vs 79.5%, p = 0.036). Furthermore, the sensitivity with BLC between the genders was significantly greater in males than in females (91.1% vs 86.7%, p = 0.035). Additionally, the false-positive rate in females was significantly higher than in males in BLC (35.9% vs 28.5%, p=0.008) and WLC (33.8% vs 27.4%, p=0.029). These findings highlight the differences in detection rates of NMIBC between genders, an area that warrants further investigation, and they continue to validate the existing evidence of increased sensitivity of BLC with Cysview in the detection of NMIBC.
Malignant urinarycytologyof unknown origin ‒ blue light flexible cystoscopyat the outpatient clinic, a Nordic prospective multicenter registry study, showed that the majority of patients, 93% (27/29), stated that they preferred to have BLC with Cysview performed with a flexible cystoscope at the outpatient clinic versus the operating room under general anesthesia. It was concluded that using BLC with Cysview with a flexible cystoscope at the office may be a simple way to solve unclear cases with malignant or suspicious urinary cytology.
"At a time when patients and physicians are seeking to ensure bladder cancer detection and surveillance are being maintained in appropriate intervals, it is encouraging to see more data supporting the use of BLC with Hexvix/Cysviewin the office setting." says Dan Schneider, President and CEO of Photocure. "Additionally, Cysviewfor use in high-risk patients helps both physicians and patients make difficult decisions that can impact patients' outcomes and quality of life. As The Bladder Cancer Company we are proud to see that more data is being collected, and that it continues to add to the already existing evidence that the use of Hexvix/Cysviewcan play a critical role in disease management."
Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000 prevalent cases (5-year prevalence rate), 550 000 new cases and almost 200 000 deaths annually in 2018.1
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
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. NMIBCremains 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 MIBCthe 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.4
1 Globocan. Incidence/mortalitybypopulation. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KDet al. World JUrol 2009;27:295–300
4 Bladder Cancer.American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
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 PhotocureASA
This press release may contain product details and informationwhich are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such informationwhich may not comply with any legal process, regulation, registration or usage in the country of your origin.
Dan Schneider President and CEO PhotocureASA Tel: + 1-609 759-6515 Email: [email protected]
Erik Dahl CFO PhotocureASA Tel: +4745055000 Email: [email protected]
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com
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