First dose cohort completed and enrolment to second dose cohort commenced in NG11-2 Phase-Ib clinical trial
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
28th July 2023 – VasoDynamics Ltd, the pharmaceutical company developing patient-friendly therapies for the prevention of debilitating side-effects induced by anti-cancer treatments, has completed the per-Protocol Safety Review of the first dose cohort. After at least 3 weeks of NG11-2 treatment, there were no Dose-Limiting Toxicities reported nor any significant safety findings on the patients treated at the first dose level of NG11-2 mouthwash prior to each radiation fraction, with concomitant immunotherapy or chemotherapy. The Safety Committee recommended to continue with the study as planned and initiate enrolment into the second, higher dose cohort.. The study is investigating the safety and preliminary efficacy of NG11-2 mouthwash for 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 the dose escalation phase followed by a dose expansion phase at the recommended phase-2 dose (RP2D), that is to be chosen following the dose escalation phase.
Dr Ningfeng Fiona Li, CEO of VasoDynamics, said:
“We are delighted with the successful completion of the first dose cohort safety review, and that the first dose level is well tolerated with some indication of promising effects on delaying the onset of severe Radiation-Induced Oral Mucositis. This is a major stepping stone in the progress of our NG11-2 Phase-Ib trial. We are looking forward to progressing the second dose cohort over the coming months.”
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
Notes to Editors:
About VasoDynamics
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-limiting 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 the most effective protection of normal tissue during cancer treatment whilst enhancing anti-cancer therapy efficacy.
