Safety and efficacy trial of whey growth factor extract for oral mucositis

TGR Biosciences has obtained the rights to a bioactive extract from milk named whey growth factor extract (WGFEA). Research on this product has included establishing a processing strategy to enrich the biologically active components in milk, characterising these components, and testing the biological activity of the material using in vitro and animal experimental models. A target symptom for treatment by the extract is chemotherapy induced mucositis. The damage to oral and gastrointestinal tissues from chemotherapy and radiation therapies is referred to as "mucositis" which is a painful and debilitating condition for which there is no available preventative treatment. With the advent of bone marrow or peripheral stem cell transplants to improve immune cell number, mucositis is now the limiting toxicity in patients receiving high-dose chemotherapy. The potential benefits of a successful preventative therapy for mucositis include reduced patient suffering, reduced cost of hospitalisation, an increased tolerance to higher dose chemotherapy and therefore more effective tumour treatment. WGFEA has been examined in two previous clinical trials including a Phase IA safety evaluation of the extract in healthy volunteers that demonstrated safety and tolerance in the form of mouthwash and slow dissolving mucoadhesive patch and a Phase IB trial that further demonstrated safety and tolerance of the mouthwash and also showed promising effects in decreasing the duration and severity of mucositis. As the next stage of this work, a Phase II study aims to further examine safety and efficacy. The trial will investigate the ability of the extract to reduce the severity of chemotherapy induced mouth ulcers and will also provide additional safety information about the product.