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Photocure ASA (OSL:PHO) New data confirms benefits of Hexvix cystoscopy and will form key part of documentation towards gaining regulatory approval in the USA
Oslo, Norway, 12 September 2008 - Photocure is very pleased to announce results from a phase III clinical study showing that fluorescence cystoscopy of the bladder using Hexvix (hexaminolevulinate) significantly improves the detection of non-invasive papillary bladder cancer. As a result of this improved procedure, more cancerous and precancerous lesions can be removed than when standard cystoscopy is used, and this significantly improves patient outcome by reducing the recurrence of bladder cancer after nine months follow-up.
The phase III study results were generated from a large, multi-center trial comparing Hexvix cystoscopy to standard cystoscopy, and involving 789 patients with bladder cancer at 28 leading hospitals in North America and Europe. Lesions identified in all patients were resected using the standard TURB procedure. The study ended in 2008 and patients were followed for possible disease recurrence for nine months after initial white light cystoscopy or Hexvix cystoscopy.
The results from the intention to treat (ITT) analysis shows that in the patients receiving Hexvix cystoscopy, the detection of non-invasive bladder cancer was significantly improved (p=0.001) compared to standard cystoscopy. These results confirm the findings from Photocure's previously completed phase III studies.
In addition, the results of this phase III study showed that the recurrence of bladder cancer lesions in patients that received Hexvix cystoscopy compared to standard cystoscopy was significantly reduced (p=0.026) nine months after the initial cystoscopy and tumor resection procedure.
This latest phase III study was conducted under a Special Protocol Assessment (SPA). Further, Photocure has been in dialog with FDA and this new data will be a key part of the additional information Photocure intends to submit in its response to FDA towards gaining approval for Hexvix in the USA.
Kjetil Hestdal, President & CEO of Photocure, comments: "We are proud that this latest study confirms and documents so clearly the medical benefit of Hexvix fluorescence cystoscopy for patients with bladder cancer. Recurrence of bladder cancer because of missed lesions represents a major healthcare issue and contributes towards it being one of the most expensive cancers to monitor and treat. This excellent new data therefore is very important to Photocure and offers the potential for a more effective diagnostic procedure and consequently improved treatment for bladder cancer patients. With these strong clinical data, we look forward to continuing our interaction with FDA in order to obtain approval for Hexvix in the USA."
Bladder cancer is the fourth most commonly diagnosed malignancy in men and tenth among women. The recurrence rate for patients with non-invasive bladder cancer is 50-70%. Bladder cancer is one of the most expensive cancers to treat because of its combination of long survival and intensive and costly routine monitoring and treatment due to the recurrent nature of the disease.
For further information, contact: President and CEO Kjetil Hestdal E-mail: kh@photocure.no Mobile: +47 913 19 535 Office: +47 22 06 22 10
CFO Christian Fekete E-mail: cf@photocure.no Mobile: +47 916 42 938 Office: +47 22 06 22 10 www.photocure.com
Photocure ASA is a Norwegian pharmaceutical company listed on the Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer.
Photocure has two proprietary pharmaceutical products on the market: Metvix®, for the treatment of sun-damaged skin and certain types of skin cancer, and Hexvix®, for the diagnosis of bladder cancer. In addition, the company has developed a proprietary light source, the Aktilite® lamp, which is used in combination with the Metvix cream. Through worldwide studies, Photocure is continuously testing its products for new indications, and the aim is to develop a pipeline of follow-on products and technologies.
Photocure®, Metvix®, Hexvix® and Aktilite® are registered trademarks of Photocure ASA.
