NG11
The company’s technology is currently
differentiated in three formulation
platforms with several product
pipelines for the protection of skin,
mucosa and hair for various types of
cancer patients.
NG11 Prevention and Reduction Of Radiation – induced Oral Mucositis (RIOM)
• NG11-1: Prevention of severe oral mucositis induced by high-dose chemotherapy (and whole body radiotherapy) in bone marrow transplantation patients
Status: US Investigator Initiated Trial (NCT02434146): 3 patients recruited (terminated)
• NG11-2: NG11-2 Phase Ib Clinical Trial for Prevention/Reduction of Radiotherapy-Induced Oral Mucositis (RIOM) in Head and Neck Cancer Patients
Status: UK Multicentre Phase-Ib Trial (IRAS ID: 1004528): ongoing
Oral mucositis is a major, acute complication of radiotherapy and chemotherapy.
Radiation-induced oral mucositis (RIOM) is a well-described, debilitating toxic side-effect affecting up to 80% of Head and Neck Cancer patients treated with radiotherapy. An estimated 56% of patients with RIOM develop a severe form of the side-effect.
Approximately 95,000 Head and Neck Cancer patients in the US are at risk of developing RIOM every year (VasoDynamics estimate based on published sources).
RIOM starts as an acute inflammation of the mouth, tongue and pharynx mucosa, followed by multiple erosions as a result of epithelial and basement membrane damage.
Symptoms of this tissue damage include oral pain and swallowing difficulties which can lead to weight loss and frequent opioid use (>50% of patients): ~70% of patients with Grade 3-4 RIOM require a feeding tube.
RIOM represents a major clinical challenge, and can result in radiation-dose limitations and changes in the dose fractionation protocol, with a potentially negative impact on the treatment outcomes, coupled with a dramatic, negative effect on the patient’s quality of life.
RIOM is associated with a significant additional healthcare cost, estimated at $17,000 per patient with Head & Neck Cancer.
Current therapy is palliative only (dietary change, pain relief medication and oral care) and no topical preventative therapy currently exists.
