A Phase-1b Dose Escalation Study to Assess the Effect of NG11-2 on Radiation Induced Oral Mucositis (RIOM) in Patients with Head & Neck Cancer.
20th January 2023 – VasoDynamics Ltd, the pharmaceutical company developing patient-friendly therapies for the prevention of debilitating side-effects induced by anti-cancer treatments, has today received the official approval from UK HRA/MHRA for their Phase-1b clinical trial application. The study will investigate the safety and preliminary effect of NG11-2 mouthwash of reducing or preventing the development of severe Radiation-Induced Oral Mucositis (RIOM), a well-known and debilitating side-effect of radiotherapy on patients undergoing treatment for head & neck cancer.
Dr Ningfeng Fiona Li, CEO of VasoDynamics, said:
“Following submission of a Clinical Trial Application (CTA) last October, we have completed a positive Ethics Committee meeting and effective communication with the MHRA, with strong support from our Chief Principal Investigator at Guy’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust. We are thrilled to have received formal approval of the CTA, which represents a key milestone in the development of our NG11 oral topical formulation platform. We are looking forward to commencing patient recruitment at 6 NHS oncology centres across the UK over the coming weeks.”
For enquiries, please contact:
Dr Ningfeng Fiona Li, CEO
Gary Bower, COO