Excellent clinical trial data from Photocure's photodynamic diagnostic Lumacan
- for detecting premalignant/malignant lesions in suspected colorectal cancer presented at Digestive Disease Week
OSLO, Norway, 21 May 2008 - Photocure's new fluorescence-based photodynamic diagnostic (PDD) product, named Lumacan(TM), continues to produce excellent results in a Phase I/II clinical trial evaluating its potential for detecting premalignant/malignant lesions in patients with suspected colorectal cancer. The final study results were presented today at Digestive Disease Week (DDW) in San Diego, CA, USA, in a talk by the principle investigator of the trial, Dr. Brigitte Mayinger from the Hospital Munich-Pasing, Germany.
Photocure has performed a dose-finding phase I/II study at two hospitals in Germany using fluorescence diagnosis in 38 patients with suspected colorectal cancer. Patients received local instillation of Lumacan in the colon before proceeding with standard colonoscopy using both white and blue (fluorescence) light. The light-sensitive active ingredient in Lumacan, hexalevulinate (HAL), is rapidly accumulated in metabolically active cancerous and precancerous cells and fluoresces red when illuminated with blue light.
The results of the study found that, of 91 lesions identified in 25 patients with suspected colorectal cancer using the gold standard approach of tissue histology, 90 lesions were detected using PDD examination with Lumacan, while only 55 lesions were detected using white-light endoscopy. Photocure's PDD approach with Lumacan therefore identified 36 more polyps than with the standard clinical procedure of white-light endoscopic imaging, an improvement of approximately 65 percent. No systemic or local side effects related to the use of Lumacan were reported.
Commenting on the results, Dr. Mayinger said, "In this trial, Lumacan conclusively demonstrated its ability to induce specific and selective fluorescence in colorectal lesions thereby significantly increasing the lesion detection rate in patients with colorectal adenoma and early carcinoma compared with standard methods. This new photodynamic diagnosis technique can also detect the flat, non-visible lesions and hidden polyps that are difficult to observe and which if missed can lead to recurrent or progressive disease. These results are very exciting and highlight clearly the potential of PDD for detecting precancerous and cancerous tissue and thereby enabling earlier and therefore more-effective treatment."
Kjetil Hestdal MD. Ph.D., President and CEO of Photocure, said: "These excellent results confirm and reinforce the interim results from this study, which were published in the February 2008 issue of Endoscopy. They strongly suggest that our new photodynamic diagnostic product could improve diagnosis of colorectal cancer significantly compared to standard procedure. We welcome this opportunity to present these promising results and to increase the awareness of PDD in the wider medical and pharmaceutical community. We look forward to the final publication."
Lumacan (hexaminolevulinate) is being developed by Photocure to improve standard colonoscopy in patients with suspected colorectal cancer. This new product is based on the Hexvix® product, which is already approved in Europe for the improved diagnosis of bladder and cancer lesions.
Patients with suspicion of 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 identifies fewer than 80% of lesions and the remaining undetected lesions may progress to colorectal cancer.
Colorectal cancer is one of the most common cancers, but only about 50% of the patients are alive five years after diagnosis. This is due to invasive and metastatic disease in more than 50% of the patients at the time of diagnosis. Colorectal cancer develops over 10-15 years and by early diagnosis and treatment, mortality from this disease may be reduced 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 of age should be screened. There are more than 10 million colonoscopies performed in EU and US annually.
Photocure ASA is a Norwegian pharmaceutical listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the diagnosis of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
Photocure®, Metvix®, Aktilite® and Hexvix® are registered trrademarks of Photocure ASA
For further information, contact: Photocure ASA Attn. Kjetil Hestdal (President and CEO) or Christian Fekete (CFO) Kjetil Hestdal (firstname.lastname@example.org), Mobile: +47 913 19 535 Christian Fekete (email@example.com), Mobile: +47 916 42 938
Posted: May 2008