Photocure: First patient enrolled in Hexvix®/Cysview® Phase 3 Market Expansion Study
Oslo, Norway, October 2, 2015: Photocure (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology, today announces that the first patient has been enrolled in the Hexvix/Cysview Market Expansion Phase 3 study. The study will investigate the use of Hexvix/Cysview in the outpatient / surveillance setting and is designed to fulfill the FDA post marketing commitments. Results from the Phase 3 study are expected to be available in 2017.
The study is a prospective, multicenter Phase 3 study comparing the detection and potential positive impact on patient management of bladder cancer in the outpatient setting with Hexvix/Cysview using Blue Light enabled flexible cystoscopy versus white light flexible cystoscopy. Eighteen top rated cancer hospitals in the USA will participate in the study, which is planned to enroll approximately 360 patients with non-muscle invasive bladder cancer.
There are approximately 1.2 million flexible cystoscopy procedures conducted on a yearly basis in the United States. The use of Blue Light Flexible Cystoscopy with Hexvix/Cysview in the outpatient / surveillance setting could allow Urologists to detect recurrences at an earlier stage, which is of great clinical benefit. Furthermore, as has been demonstrated with the current use of Hexvix/Cysview during bladder cancer resection with blue light rigid cystoscopes, the addition of Hexvix/Cysview in the surveillance of bladder cancer patients may lead to better and earlier patient management decisions resulting in improved clinical outcomes and health economic savings.
Dr. Raj Pruthi, Professor and Chair, Department of Urology, University of North Carolina, Chapel Hill said: "The positive benefits of Hexvix/Cysview are well documented in numerous trials for patients undergoing bladder cancer resections during cystoscopy examination in the operating room. We are looking forward to conducting the study with Blue Light Flexible Cystoscopy with Hexvix/Cysview to confirm the benefits of this technology also in the outpatient setting. Early detection of more lesions is expected to result in better treatment decisions as well as more appropriate referrals and follow-up regimens, which in turn will reduce the burden on patients and the health care system."
Kjetil Hestdal, President & CEO said: "This is an important milestone for Photocure as we seek to expand the use of Hexvix/Cysview into the bladder cancer surveillance market. Enabling Blue Light flexible cystoscopy with Hexvix/Cysview in the surveillance setting will allow patients with non-muscle invasive bladder cancer access to optimal treatment earlier, resulting in improved long-term benefits for these patients. While this trial is ongoing in the USA, we will be obtaining additional clinical and health economic data in EU from the use of Hexvix/Cysview in the same setting in order to optimize best clinical practices and patient outcomes."
For more information about the clinical trial: https://clinicaltrials.gov/ct2/show/NCT02560584
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no
CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.no
About Photocure ASA
Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions in disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions that can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.
About Hexvix®/Cysview®
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology 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®/Cysview® is approved in Europe, Canada and the USA.
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)