Clinical study progresses to final dose level to assess the effect of NG11-2 mouthwash on Radiation Induced Oral Mucositis (RIOM) in patients with head and neck cancer

A Phase-1b Dose Escalation Study to Assess the Effect of NG11-2 mouthwash on Radiation Induced Oral Mucositis (RIOM) in Patients with Head & Neck Cancer.

VasoDynamics Ltd, the pharmaceutical company developing patient-friendly therapies for the prevention of debilitating side-effects induced by anti-cancer treatments, has successfully completed enrolment into the first three dose levels of NG11-2 treatment and the Safety Committee Meeting today agreed to escalate to the final, and highest, dose level. The dose escalation phase has now successfully enrolled six patients over three escalating dose levels. NG11-2 mouthwash administered once daily prior to each fraction of radiotherapy is well tolerated with no Dose-Limiting Toxicities identified at the three dose levels. Based on the safety profile seen to date, the Safety Committee decided to support further dose escalation to the final, and highest, dose level planned as per Protocol. Recruitment into the last cohort is open now with treatment anticipated to start in mid-Jan 2024.

The study is investigating the safety and preliminary efficacy of NG11-2 mouthwash in reducing and preventing severe Radiation-Induced Oral Mucositis (RIOM), a well-known and debilitating side-effect of radiotherapy on patients undergoing treatment for head & neck cancer. The study consists of a dose escalation phase followed by a dose expansion phase at the recommended phase 2 dose (RP2D) which will be selected following the dose escalation phase.

Ningfeng Fiona Li, CEO of VasoDynamics, said:

“We are very pleased with the successful progression of the dose escalation phase and entering into the final, and highest, dose level planned. In the coming year, we are looking forward to seeing the full safety and preliminary efficacy profile of NG11-2 through the four escalating dose levels.”

For enquiries, please contact:

Dr Ningfeng Fiona Li, CEO +44 7969132263
fiona.li@vasodynamics.co.uk
Gary Bower, COO +44 7960388412
gary.bower@vasodynamics.co.uk