According to a press release from American biotechnology company Soligenix, the European Medicines Agency’s (EMA) Pediatric Committee recently agreed to the Company’s Pediatric Investigation Plan (PIP) for experimental oral mucositis drug SGX942 (dusquetide).
Pediatric investigation plans are a part of European pharmaceutical regulation. They are a sort of plan outlining future clinical trials that will be conducted to evaluate the effectiveness of a new drug in pediatric patients. All drugs seeking market approval in Europe must first get a PIP approved, in addition to numerous other hurdles.
About Oral Mucositis
Oral mucositis is one of the most frequently experienced adverse reactions to radiation and chemotherapy in cancer patients. Mucosal tissue, such as the tissue forming the walls of your intestines or the roof of your mouth, is highly susceptible to damage from these aggressive but often-necessary cancer therapies.
Oral mucositis is a condition where the oral mucosa, the mucosal lining of the mouth, becomes heavily inflamed and irritated. Bloody sores can develop, and painful burning sensations may be common – especially when eating. The sores and associated pain may make it difficult to speak or swallow as well.
40% of patients receiving chemotherapy experience some degree of oral mucositis. In cases originating with chemotherapy it typically stems from low white-cell count, while radiation therapy can more directly damage oral mucosa through the inflammatory effects of radiation on the tissue.
SGX942 is an experimental drug designed to treat oral mucositis in head and neck cancer patients. As you may have guessed from the name, these are cancers chiefly affecting parts of the neck. Because of where these cancers are typically located, radiation therapy might be especially damaging to the oral mucosa.
Currently SGX942 is undergoing a phase 3 clinical trial designed to evaluate the drug’s effectiveness in combating oral mucositis in adult patients. The EMA agreed that Soligenix could wait for the conclusion of the phase 3 trial before beginning research for the PIP. Normally that wouldn’t be the case, but in this instance, the regulatory agency agreed that the biotech firm could finish evaluating the potential risks and benefits in adult patients before beginning pediatric research.
Recruitment from the phase 3 trial is set to begin this year, with results expected to come some time in 2020. That means any action on the PIP could be as much as a year away.
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