Released: Tuesday 6th December 2016
Lamellar Biomedical Announces Completion of Patient Recruitment in the Pivotal Registration Clinical Study Assessing Visco-ease for the Treatment of Radiotherapy-Induced Xerostomia (RIX)
Bellshill, Glasgow, UK 6 December 2016 - Lamellar Biomedical, a biotechnology company developing a range of patent-protected medical and pharmaceutical products, based on LAMELLASOMETM technology, announces that patient recruitment has been completed in the pivotal registration clinical study assessing Visco-ease’s ability to restore the function of saliva in patients undergoing radiotherapy for the treatment of Head and Neck Cancer. RIX (dry mouth) is the most significant clinical adverse event associated with radiotherapy for which there is no effective current treatment.
The pivotal trial is a double blind, randomised, placebo controlled, single centre, parallel group study. Patients have been randomised to receive Visco-ease or placebo, both of which are delivered via a spray device specially developed for use in the oncology setting. The study, which is being conducted in conjunction with The Beatson West of Scotland Cancer Centre, has recruited a total of 44 patients.
The primary end-point of the study is to quantify the effectiveness of Visco-ease when compared to placebo in ameliorating dry mouth as assessed by the Groningen Radiotherapy-Induced Xerostomia questionnaire (GRIX). The secondary endpoints of the study focus on the safety of Visco-ease.
The results of the study will be reported in March 2017.
Alec McLean, the CEO of Lamellar Biomedical, said: “The completion of patient recruitment in this pivotal clinical study with Visco-ease is an important corporate milestone for Lamellar Biomedical. I am looking forward to the release of the results of the study which we believe will show that Visco ease is an important advance in the treatment of RIX and will help achieve this innovative product’s approval.”
For further information, please contact:
Lamellar Biomedical Citigate Dewe Rogerson
Dr Alec McLean David Dible/ Pip Batty
Tel: 01698 748832 Tel: 020 7282 1022
NOTES TO EDITORS:
About Radiotherapy-Induced Xerostomia (RIX)
RIX is a common and the most severe complication of radiotherapy for Head and Neck Cancer (HNC) associated with hypo-secretion of saliva, thick viscous mucus, inflammation and infections (oral mucositis), which can greatly impact patients’ ability to eat, swallow and talk. The annual incidence of new HNC (laryngeal, oral and pharyngeal) is 139,000 in EU-28 and 57,000 in North America: of these, 90% of patients receive radiotherapy, with approximately 90% of these patients developing RIX. The 5-year survival of HNC is ~60%, with circa ~50% of patients needing treatment for life-long chronic RIX.
About Lamellar Biomedical
Lamellar Biomedical is the only company globally focused on LAMELLASOME™ technology (micron-scale lipid vesicles) which has multiple medical applications.
Lamellar Biomedical’s development pipeline includes a number of patent-protected medical devices and pharmaceuticals targeting RIX, Dry Eye Disease, Cystic Fibrosis and Infection. These are all conditions that are poorly served by current medications and therefore represent areas of high value unmet medical need.
LAMELLASOME™ technology produces mimetics of human serous lamellar bodies. These regulate the internal interfaces between human tissues as well as the interfaces between tissues and the external environment as in the mouth and lungs. They act biophysically are muco-restorative and have the potential to resolve a broad range of disease states that are associated with dry or sticky mucosal surfaces and topical infection.
Lamellar Biomedical is based near Glasgow, Scotland. It has been financed by a range of investors including Invesco, Barwell, TRI Capital and Scottish Enterprise.