Photocure is developing its new fluorescence-based photodynamic diagnostic (PDD) product, named Lumacan(TM), to improve standard colonoscopy in patients with suspected colorectal cancer. This new product is based on its Hexvix® product, which is already approved in Europe for the improved diagnosis of bladder cancer lesions.

Patients with suspected colorectal cancer are routinely examined by visual inspection of the colon (colonoscopy). The entire colon is examined to find tumors and polyps, however, this approach is effective in identifying fewer than 80% of lesions, and those missed may progress to colorectal cancer.

Photocure has performed a dose-finding Phase I/II study at two hospitals in Germany using its PDD product in 32 patients with suspected colorectal cancer. Patients received local instillation of the photosensitive compound hexaminolevulinate (HAL) in the colon before proceeding with standard colonoscopy using both white and blue light. HAL is rapidly accumulated in metabolically active cancerous and precancerous cells and fluoresces red when illuminated with blue light.

The results from the first 12 patients have now been published in the February 2008 issue of Endoscopy* by Dr. Brigitte Mayinger, Hospital Munich-Pasing, the principle investigator of the study. Using histological findings as the gold standard, 52 of 53 (98%) of premalignant/malignant lesions showed red fluorescence under the PDD examination and 38 of 53 (72%) lesions were detected with white-light endoscopy. Photocure's PDD approach therefore located 28% more polyps than identified with standard white-light endoscopic imaging.

No systemic or local side effects related to the use of HAL are reported. Patient recruitment for this trial was completed at the end of November 2007 and the full data from the study is currently being analysed.

Dr. Mayinger says, "Administration of HAL enema induces selective lesion fluorescence and increases the lesion detection rate in patients with colorectal adenoma and early carcinoma."

Kjetil Hestdal MD. Ph.D., President and CEO of Photocure, comments, "These published results strongly suggest that our new photodynamic diagnostic product will improve diagnosis of colorectal cancer to a similar extent to what we have shown can be achieved in patients with bladder cancer. We look forward to the full analysis of the trial, which we hope will confirm this highly encouraging result." 

Colorectal cancer is one of the most common cancers, but only about 50% of patients survive for more than five years after diagnosis, owing to its highly invasive and metastatic nature. Colorectal cancer develops over 10-15 years and early diagnosis and treatment has the potential to reduce mortality from this disease by more than 90%. Colorectal polyps are quite common in the elderly population and health authorities in EU and US recommend that all women and men above 50 years should be screened. There are more than 10 million colonoscopies performed in EU and US annually.

*Mayinger, B., Neumann, F., Kastner, C., Degitz, K., Hahn, E. G. and Schwab, D.

Early detection of premalignant conditions in the colon by fluorescence endoscopy using local sensitization with hexaminolevulinate. Endoscopy (2008) Vol. 40, Issue 02