NG11-2 Phase Ib clinical trial

NG11-2 Phase-Ib Clinical Study Report Complete

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 2025

VasoDynamics Ltd, the pharmaceutical company developing patient-friendly therapies for the prevention of debilitating side-effects induced by anti-cancer treatments, is pleased to announce that the Study Report on the Phase-1b study, using NG11-2 vasoconstrictor mouthwash to reduce and prevent severe Radiation-Induced Oral Mucositis (RIOM), has been completed. The results will be made available on the VasoDynamics website and public websites such as ISRCTN and clinical trials.gov.

In brief, a total of 15 patients with head and neck cancer have been successfully enrolled in this Phase-1b study with daily oral topical treatment of NG11-2 prior to each fractional radiation dose throughout their radiotherapy regime, for up to 7 weeks. Four dose levels of NG11-2 were tested and total of 9 patients treated at the highest dose level. The results indicated:

· No Dose Limiting Toxicities were seen among all four dose levels tested, and the Recommended Phase 2 Dose (RP2D) was determined accordingly.

· NG11-2 was considered well tolerated in the patient population included in this study.

· NG11-2 showed positive preliminary efficacy results with decreases in the duration and the incidence of severe RIOM, and increases in the time-to-onset of severe RIOM observed with escalating dose levels.

· The results from this study support the continued development of NG11-2.

Dr Ningfeng Fiona Li, CEO of VasoDynamics, said:

“We are delighted to announce the completion of the Clinical Study Report with the successful results which delivers an exciting development milestone for the NG11-2 programme, and also represents a safety validation milestone for all the topical vasoconstrictor platform programmes. We look forward to moving NG11-2 and the other vasoconstrictor platform programmes into the next stage of pivotal development.”

For enquiries, please contact:

Dr Ningfeng Fiona Li, CEO
fiona.li@vasodynamics.co.uk

Gary Bower, COO
gary.bower@vasodynamics.co.uk

Notes to Editors:

About VasoDynamics

VasoDynamics is a pharmaceutical development company based in Stevenage-London, UK. It is a clinical stage biopharma company with experienced and culture-diversified executives who have shared vision to improve the standard of cancer care globally. Recognising the mounting cost pressures facing healthcare payers all over the world, the company is developing a number of cost-effective medicines, all of which target the prevention of debilitating and often dose-limiting complications of cancer therapy, such as chemotherapy and radiotherapy induced mucositis, dermatitis, and hair-loss. We take great pride in our culture of scientific and development rigour, and our programmes are based on scientific finding and innovations from world-leading research bodies. The company’s proprietary technology platform utilises the different dynamics of normal and cancerous vasculatures developing a serials of pipeline products for various types of cancer patient cohorts, hence to achieve the most effective and patient friendly protections to prevent severe side-effects during various types of cancer treatments.