Date: 2011-09-15
Type of information:
phase: 1b
Announcement: results
Company: Actogenix (Belgium)
Product: AG013
Action mechanism: AG013 is the lead product of ActoGenix\'s proprietary ActoBiotics™ platform, a novel class of orally administered and locally acting therapeutic proteins.
Disease: prevention of oral mucositis in head and neck cancer patients receiving chemo-induction therapy
Therapeutic area: Cancer Oncology
Country: USA
Trial
details:
The phase 1B study was a randomized, single blinded, placebo-controlled study evaluating safety and tolerability, as well as initial efficacy of AG013 administered as an oral rinsing solution in 3 dose frequencies (once daily, 3 times/day, and 6 times/day) over a 14 day treatment period. The study was conducted in 6 major US cancer centers. In total 19 patients (14 active, 5 placebo) fulfilled the criteria for a per protocol analysis of efficacy.
Latest
news: ActoGeniX has announced the results of a Phase 1B study evaluating the AG013 oral rinsing solution for the prevention of oral mucositis in head and neck cancer patients receiving chemo-induction therapy.
AG013 was proven safe and well tolerated. Analysis of initial efficacy showed a 35% reduction of the percentage of days with ulcerative oral mucositis in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of patients treated with AG013 were full responders (defined as no or 1 day of ulcerative oral mucositis) while all placebo-treated patients developed ulcerative oral mucositis.
The phase 1B study has been designed to be the initial step in evaluating AG013 in cancer patients who develop oral mucositis as a result of chemotherapy or radiation therapy. AG013 was safe and well tolerated. Analysis of initial efficacy showed a 35% reduction of the percentage of days with ulcerative oral mucositis in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of patients treated with AG013 were full responders (defined as no or 1 day of ulcerative oral mucositis) while all placebo-treated patients developed ulcerative oral mucositis.
Although the phase 1B study was designed and powered to primarily demonstrate safety and tolerability, the initial efficacy data demonstrate that AG013 may be effective in the prevention of oral mucositis in cancer patients.
ActoGeniX is currently preparing to bring AG013 to the next phase of clinical development and intends to start the phase 2 study in the course of 2012.
