Photocure - Hexvix®/Cysview(TM) demonstrates long term benefit -Results from 5.5 year follow up of recurrence of bladder cancer
Oslo, Norway May 12th 2011: Photocure (OSE: PHO), a Norwegian pharmaceutical company specialising in cancer and dermatology, announces the results from a 5.5 year follow up of recurrence in patients with Non Muscle Invasive Bladder Cancer (NMIBC) showing a long term benefit of the use of Hexvix compared to patients who received white light cystoscopy alone. After a follow-up up period up to 5.5 years, the number of patients who have experienced recurrence of their bladder cancer is lower, and the time it takes before the recurrence occurs is longer when they had Hexvix-guided fluorescence cystoscopy.
This clinical study includes retrospective follow up from 526 patients included in a prospective randomized Phase III trial in 28 centers in EU and North America. The results from this Phase III study were published in Journal of Urology November 2010 by Stenzl et al. In this 5.5 year follow-up study data were collected related to additional bladder cancer recurrences after they had completed the prospective Phase III trial.
The results (Intention to Treat) showed that fewer patients who received Hexvix experienced recurrence of their bladder cancer compared to patients who did not receive Hexvix, e.g. 38% in the Hexvix group versus 31.8% in the group that did not receive Hexix had no recurrence during the 5.5 year observation period. A statistically significant difference was observed between the recurrence free survival curves, p=0.04.
Dr. H. Barton Grossman, Clinical Professor of Urology at MD Anderson Cancer Center, Houston, USA says," The results of this long-term follow up study are very impressive and demonstrate that Hexvix is an important tool to improve the detection and treatment of bladder cancer".
Bladder cancer has the highest rate of recurrence of all cancer types. This results in a very high prevalence of disease which requires patients to return for regular follow-ups and treatment. Per patient, bladder cancer is the most expensive cancer to treat, in part because of the diagnostic testing and treatment of recurrent disease.
Kjetil Hestdal, President & CEO of Photocure comments, "We are very pleased to see the results of this study which demonstrates the long-term benefit of using Hexvix-guided fluorescence cystoscopy for patients with bladder cancer. We have earlier demonstrated in two clinical studies that there is a reduction of bladder cancer recurrence after using Hexvix- guided fluorescence cystoscopy at 9 and 12 months. This is the first study to demonstrate that this effect is durable lasting for over 5 years".
About Photocure ASA
Photocure ASA is a worldwide leader in photodynamic therapy. Listed on the Oslo Stock Exchange (OSE: PHO), Photocure develops and sells products for the photodynamic treatment and diagnosis of cancer and selected dermatology indications. The company strives to solve unmet needs by developing new and innovative solutions based on its patented Photocure Technology(TM). Photocure markets and sells its own products in selected markets and has developed strong partnerships with leading pharmaceutical companies on a regional and global basis. Photocure's bladder cancer diagnostic product, Hexvix® is approved in the European Union and the US. Setting new standards for diagnosis and treatment of several different conditions, Photocure Technology(TM) is very selective, targeting only diseased cells and preserving healthy tissue. Photocure Technology(TM) is being tested for new products and indications including acne, improving the appearance of skin (Allumera(TM)), diagnosing colon cancer (Lumacan® which is outlicensed to Salix Pharmaceuticals) and the treatment of pre-malignant cervical lesions (Cevira®).
About GE Healthcare
GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease, so their patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
For more information, please contact:
Kjetil Hestdal, President and CEO
E-mail: kh@photocure.no
Mobile: +47 913 19535
Christian Fekete, CFO
E-mail: cf@photocure.no
Mobile: +47 916 42 938
This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)