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
14th December 2023 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
Gary Bower, COO +44 7960388412
Notes to Editors:
VasoDynamics is a UK-based pharmaceutical development company focused on improving the standard of cancer care globally. Recognising the mounting cost pressures facing healthcare payers all over the world, VasoDynamics is developing cost-effective medicines for the prevention and treatment of debilitating, and often dose-limitin,g complications of cancer therapy, such as chemotherapy and radiotherapy-induced mucositis, dermatitis and hair-loss. The company’s proprietary technology platform utilises the different dynamics of normal and cancerous vasculature to achieve selective protection of normal tissue during cancer treatment whilst facilitating anti-cancer therapy efficacy.