FDA approval of Phase II clinical trial
July 11, 2012
Izun Pharma was granted approval by the FDA to enter into a Phase II clinical trial of IZN-6N4, its product for the prevention and treatment of Oral Mucositis (OM). OM, a side effect of radiation and/or chemotherapy, is characterized by ulceration of the oral cavity, causing patients to suffer from infection, intense pain and malnutrition.
Severe OM occurs in 35-50% of all patients undergoing chemotherapy as part of cancer treatment. Fifty percent of bone marrow transplant patients and 90% of head and neck cancer patients receiving radiation therapy also suffer from OM. Often, these potentially lifesaving treatments need to be interrupted as a result.
Results of Part 1 of the clinical trial, which was completed in Israel, showed a dramatic effect in preventing mucositis. Part II will include multiple US-based hospital centers, as well as the original Israeli sites. Recruitment for Part II of the trial is progressing well.