Home About Products ProDermaCel™ DermX OralX Research Markets Contact News	OralX, a topically applied pharmaceutical, will protect normal oral, pharyngeal and esophageal mucosa from the mucositis that commonly follows head and neck radiotherapy and/or systemic chemotherapy. In National Cancer Institute scoring criteria, the severity of oral mucositis ranges from Grade 1 (mild erythema) to Grade 5 (death related to toxicity). Several recent reviews (e.g., Sonis et al., Cancer 100:1995-2025, 2004) have described the pervasive and severe nature of oral mucositis in cancer patients receiving head and neck radiotherapy and/or systemic chemotherapy, particularly with some common drug regimens such as a taxane + 5-FU where severe, Grade 3-4 mucositis is reported in as many as 40-65% of patients. Acute damage to the oral mucosa as a result of head and neck radiotherapy was reported to occur in 85% of patients based upon symptom reporting and in 100% of patients based upon histology. Mucositis is both painful and expensive when measured in the extra hospitalization days required to treat it ($42,000/patient in the year 2000; Sonis et al., J. Clin. Oncol. 19:2201-2205, 2001). Oral mucositis can also cause patients to withdraw from chemotherapy, either for days or even for entire cycles. Though rarely life-threatening, when oral mucositis occurs in immune-compromised cancer patients it carries significant risk because it can lead to septic infections and occasionally death. Radiotherapy-associated irradiation or delivery of cytotoxic chemotherapy drugs cause mucosal stem cells as well as mucosal endothelial and extracellular matrix cells to undergo apoptosis and die. Cell death causes gaps within the otherwise intact mucosal surface, and these gaps support the growth of bacterial and fungal organisms commonly present within the oral cavity, leading to the occurrence of large, pseudomembranous sores in the oral cavity. Product Specifications: OralX is formulated as a clear, colorless, odorless liquid that is topically applied to the oral, cheekpouch mucosa of hamsters minutes before the cheekpouch is irradiated from an external beam gamma source. Hamster model experiments (see insert) have shown complete prevention of Grade 1 through Grade 3 mucositis (grade 4 not tested). ProCertus believes that related topical formulations of OralX may have use for the prevention of radiotherapy-induced proctitis in prostate cancer patients and cervical cancer patients.