Date: 2012-09-22
Type of information:
phase: 1
Announcement: results
Company: ActoGeniX (Belgium)
Product: AG013
Action
mechanism: AG013 is the lead product of the ActoGeniX’ pipeline of the proprietary ActoBiotics™ platform. ActoBiotics™ represent a novel concept for oral administration of therapeutic proteins, and are designed to be safer and more effective than injectable biopharmaceuticals in selected GI and inflammatory diseases.
Disease: prevention of oral mucositis
Therapeutic area: Cancer - Oncology
Country:
Trial details: The phase 1 PK study in healthy volunteers has been designed to evaluate the PK profile (bacterial count and protein level) of AG013 administered once or three times per day. Also, the influence of food and beverage intake on the PK profile of AG013 was evaluated. Overall, consistent levels of AG013 (bacterial count and protein) could be recovered from the different sample sites in the oral cavity, and this up to 24 hrs.
Latest
news: * On August 22, 2012, ActoGeniX, a clinical stage biopharmaceutical company focused on the development and commercialization of ActoBiotics™, a novel class of orally administered and locally acting biopharmaceuticals, has announced the positive results of a Phase 1 pharmacokinetic (PK) study evaluating the AG013 oral rinsing solution for the prevention of oral mucositis. Analysis of the pharmacokinetic profile showed that live AG013 bacteria adhere to the buccal mucosa and actively secrete protein locally, resulting in homogeneous exposure to the entire mucosal surface up to 24 hours after administration of a rinse. These data provide further support for the clinical development of AG013 in oral mucositis. Recently, a phase 1b study of AG013 provided initial efficacy data, including a 35% reduction in the duration of ulcerative oral mucositis in AG013-treated patients versus the placebo-treated patients, and close to 30% response rate in the active group versus no response in the placebo group. ActoGeniX is currently preparing to bring AG013 to the next phase of clinical development in cancer patients who develop oral mucositis as a result of chemotherapy or radiation therapy.
