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Drugs R D. 2005;6(4):235-8.

Hexyl aminolevulinate: 5-ALA hexylester, 5-ALA hexylesther, aminolevulinic acid hexyl ester, hexaminolevulinate, hexyl 5-aminolevulinate, P 1206.

[No authors listed]


Hexyl aminolevulinate [aminolevulinic acid hexyl ester, hexyl 5-aminolevulinate, 5-ALA hexylester, hexaminolevulinate, Hexvix, Hexvix PD, Hexvix PDT, P 1206] is being developed by PhotoCure, a Norwegian company, for the diagnosis and treatment of bladder cancer. The current standard diagnosis of bladder cancer involves cystoscopic examination of urine and bladder washings and is combined with biopsy for better detection of low-grade malignancies. However, the method largely relies on the experience of the surgeon and often results in false negatives especially for low-grade malignancies and pre-cancerous tissues. Photocure believes that imaging with hexyl aminolevulinate (Hexvix) offers significant advantages over standard diagnostic methods for detection of bladder cancer and also can be used in combination with those to ensure the optimal diagnostic accuracy. PhotoCure's procedure for diagnosis of bladder cancer involves filling of the patient's bladder with hexyl aminolevulinate solution and allowing the active agent to accumulate in the cancerous tissue. Following bladder emptying, blue light illumination is applied to the bladder causing red fluorescence that is clearly visible, thus identifying the cancerous tissue. Imaging with hexyl aminolevulinate improves detection of bladder tumours and also can be used together with transurethral resection to check the completeness of tumour removal. PhotoCure is looking for the opportunity to out-license hexaminolevulinate for all regions except the Nordic regions. PhotoCure has proprietary rights for hexyl aminolevulinate from the Norwegian Radium Hospital. Under the terms of the agreement with the Norwegian Radium Hospital, PhotoCure gains an access to, and an option to acquire, all of the new photodynamic therapy technologies developed by the Norwegian Radium Hospital. For its part, PhotoCure provides research and development funding to the Norwegian Radium Hospital. This 3-year agreement was extended in February 2003 until December 2006. PhotoCure and Karl Storz GmbH of Germany have signed a formal collaboration for the development and marketing of hexyl aminolevulinate (Hexvix) and Karl Storz's D-light system. The two systems will be used in the diagnosis of bladder cancer. PhotoCure and Karl Storz GmbH will jointly apply for a marketing approval of hexyl aminolevulinate (Hexvix) and Karl Storz' D-light system in the US for detection of bladder cancer. The D-light system is already approved in Europe. PhotoCure has also formed a collaborative agreement with the Swiss Federal Institute of Lausanne and the Municipal University Hospital in Lausanne. These institutions have conducted preclinical studies and some exploratory clinical research on the active ingredient of Hexvix in approximately 100 patients. The first MAA for hexyl aminolevulinate fluorescence was filed in Sweden, the reference member state, in December 2002, and was approved in September 2004. PhotoCure plans to launch hexyl aminolevulinate in Sweden in June 2005. Phase II clinical trials were conducted in 52 patients with known or suspected bladder cancer at the university clinics in Switzerland, Germany, Sweden and Norway. Clinical data suggests that hexyl aminolevulinate (Hexvix) is useful in the early diagnosis of bladder cancers allowing treatment to be performed at an earlier stage and, thus, improve the chance of a successful clinical outcome. The company believes that the data from the US phase III programme at 19 leading urology clinics and two multicentre European trials at 28 leading hospitals across nine countries, will sufficiently support an NDA with the US FDA. The US phase III programme with hexyl aminolevulinate was initiated in December 2001. The results from the first European multicentre study conducted in 19 centres in 286 patients confirmed the advantages of hexaminolevulinate fluorescence cystoscopy over standard white light cystoscopy in the detection of bladder cancer. The second multicentre phase III study at ten centres in Germany and the Netherlands in 146 patients with known or suspected bladder cancer was sucessfully completed in March 2003. The independent blind reviewer acknowledged that imaging with hexyl aminolevulinate would result in better treatment options in every fifth patient compared with standard cystoscopy. Hexaminolevulinate is also undergoing early feasibility studies for the diagnosis and treatment of gynaecological and gastrointestinal conditions. PhotoCure was granted a European patent No. 0820432 covering hexyl aminolevulinate, an active ingredient used in Hexvix for the diagnosis and treatment of bladder cancer. The company was also granted patents in Australia, China, the Czech Republic, New Zealand, Russia, Singapore, South Korea and the US.

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