Update on Clinical Study Assessing Visco-ease for Treatment of Radiotherapy-Induced Xerostomia (RIX)
Bellshill, Glasgow, UK 12 May 2017- Lamellar Biomedical, a biotechnology company developing a range of patent-protected medical and pharmaceutical products, based on LAMELLASOMETM technology, provides an update on the results of the clinical study assessing the ability of Visco-ease to restore the function of saliva in patients undergoing radiotherapy for the treatment of Head and Neck Cancer.
The study, which was conducted in conjunction with NHS Greater Glasgow & Clyde (GG&C) and the Beatson West of Scotland Cancer Centre, involved a total of 44 patients. The study reported that Visco-ease was very safe and highly tolerable. The primary efficacy end-point of the study was the comparison of Visco-ease to placebo in ameliorating dry mouth targeting a 30-point reduction in the Groningen Radiotherapy-Induced Xerostomia (GRIX) questionnaire. While the primary endpoint was not met, post hoc analysis indicated sufficient efficacy (a ~15-point change) to support the continued investigation of Visco-ease as a treatment for RIX.
Lamellar Biomedical, in conjunction with NHS GG&C and the Beatson, are currently exploring a number of strategies that will optimize the effectiveness of Visco-ease. A key development under way is a Visco-ease formulation change, specifically analysing the concentration and volume of product applied. Once the new formulation has been developed, Lamellar plans to conduct a further clinical study with the support of both NHS GG&C and the Beatson, both of whom remain positive about the ability of Visco-ease to provide a solution to patients suffering from RIX. It is planned to run this study in patients with chronic RIX as this provides a group with more stable, established symptoms, compared to those actively receiving radiotherapy.
Alec McLean, the CEO of Lamellar Biomedical, said: “The outcome of this clinical study with Visco-ease, while disappointing, has provided us with important insights that will allow us to re-formulate the product to enhance the treatment benefits that it delivers to patients with RIX. We are looking forward to working with both NHS GG&C and the Beatson as work to bring this innovative product to the market continues.”